Integrative and Functional Medicine: The Role of a Registered Dietitian Nutritionist in Treating and Preventing Chronic Disease

by

Whitney Parkinson

The University of North Carolina at Chapel Hill

Gillings School of Global Public Health

A paper submitted to the faculty of the University of North Carolina at Chapel Hill in partial fulfillment of the requirements for the degree of Master of Public Health in the Department of Nutrition

May 5, 2021

1 Integrative and Functional Medicine: The Role of a Registered Dietitian Nutritionist in Treating and Preventing Chronic Disease

Statement of the Problem:

Chronic health conditions and healthcare costs are rising and the current conventional medicine model of treatment is not solving the problem. The emergence of the novel COVID-19 virus magnified the devastating effects chronic disease has on the U.S. population, as well as our current reliance on expensive pharmaceutical drugs and in-patient care as a ‘band-aid solution’ for chronic issues. Most chronic diseases can be treated and prevented with lifestyle and diet, leading patients to shift their focus towards nutrition and lifestyle-centered-personalized treatment options.

Integrative and Functional Medicine Nutrition Therapy (IFMNT) is individualized and patient- centered, and requires a detailed understanding of each patient’s genetic, biochemical, and lifestyle factors and leverages that data to direct personalized treatment plans that lead to improved patient outcomes. It targets the prevention and treatment of chronic disease by emphasizing healthy lifestyle changes and a well-balanced intake of nutrient-rich foods. The knowledge and critical thinking of Registered Dietitian Nutritionists (RDNs) is the core of IFMNT and facilitates a new set of diagnostic tools and a treatment philosophy. IFMNT is important to incorporate into the current system of care to help solve the chronic health crisis. However, systemic inequities, including income and education-level disparities, as well as disparities in access to healthful foods and health insurance, create limitations on the effectiveness of IFMNT and need to be addressed for IFMNT to impact those who need it most.

Introduction: Current Health Challenges

Our country is facing a current healthcare epidemic and economic crisis. The health conditions significantly contributing to persistent disease and economic cost are chronic conditions. According to the National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), 90% of the nation’s healthcare expenditure goes towards treating chronic and mental health conditions, which amounts to an estimated 3.8 trillion dollars annually (NCCDPHP, 2021). A chronic disease is defined as a health condition that lasts one or more years, which limits a patient’s ability to complete daily activities and requires ongoing medical attention.

The burden of chronic disease on the nation is staggering. Over 50% of the U.S. population suffers from chronic diseases, such as diabetes, cardiovascular disease and cancer, which are the leading causes of death and disability in the United States (Valencia et al., 2018). U.S. healthcare costs continue to rise annually (4.7% in 2018, 4.6% in 2019), with 17.7 percent of the U.S. economy allocated to healthcare spending in 2019.

The costs associated with healthcare spending mostly include prescription drugs, hospital care, and clinical and physician services (Martin et al., 2020). Prescription drugs are more expensive in the U.S., with prices being twice as high as in Canada, Australia and the U.K. To exacerbate

2 the problem, the average adult in the U.S. takes more prescription drugs than adults in almost every other country (The Commonwealth Fund, 2015). As a result, the United States spends roughly 1.5 to 2 times more per person treating disease than other countries, but the population reports higher rates of chronic disease and lower life expectancy, with rates of chronic conditions and obesity being higher in the U.S. than all other countries globally (Hanaway, 2016). Studies estimate that by 2022 healthcare costs will rise to more than 20% of the GDP (Hanaway, 2016).

In 2014, 42 percent of Americans had multiple chronic conditions. Americans with five or more chronic health conditions make up 12 percent of the population, but account for 41 percent of total healthcare costs and spend 14 times more on health services than those without chronic conditions. People with five or more chronic conditions use twice as many prescription drugs on average per year and make about 20 doctor’s visits per year. Their out-of-pocket cost was six times higher with private insurance, than people with no chronic conditions. This spending was nearly five times higher with Medicare and nine times higher with public insurance (Buttorff, et al., 2017).

Despite the magnitude of chronic disease and healthcare costs in the U.S., conventional healthcare has not changed significantly and is still largely focused on temporary fixes, or acute remedies. Medical education has also not changed significantly in response to the current crisis, with studies and critiques giving little or no attention to the rising dominance of chronic disease in the U.S. (Holman, 2020). Now, with the emergence of the COVID-19 virus, mortality and healthcare costs from chronic disease have risen dramatically as a result of the increased mortality experienced by the chronically ill.

The emergence of COVID-19 has exposed how deadly pre-existing chronic conditions can be to survival. The National Center for Immunization and Respiratory Diseases (NCIRD) cites that COVID-19 poses a direct threat to those with any chronic disease (NCIRD, 2021), particularly hypertension, diabetes, cardiovascular disease, chronic lung disease, chronic kidney disease, chronic obstructive pulmonary disease (COPD) and asthma (Khan et al., 2020). With over 50% of the U.S. population suffering from chronic diseases, over 568,000 people have died from the virus. (CDC, 2021).

The deadly effects of COVID-19 are not only experienced by the chronically ill but by the entire population through a disruption of routine healthcare, unemployment, and related mental health issues. Many Medicare beneficiaries have already experienced substantial disruptions in their care and surveys done by the Primary Care Collaborative reveal that more than a third of primary care physicians found that their patients with chronic conditions are in “noticeably worse health resulting from the pandemic,” with over one half experiencing increased negative health burdens due to delayed or inaccessible care (The Commonwealth Fund, 2021). The effect of low socioeconomic status on overall health has repeatedly been highlighted in the U.S.; those with socio-economic problems are more likely to consume unhealthy food and engage in less physical activity (Danhieux et al., 2020).

Chronic conditions do not appear overnight, but are typically the result of years of poor diet and lifestyle choices, combined with increased exposure to environmental toxins. In the past, preventive healthcare has taken a backseat in our medical system. The staggering number of

3 chronic conditions and comorbidities in the country have left the U.S. unequipped to deal with the pandemic, leaving healthcare workers and hospitals overwhelmed and unprepared.

Dietitians can play an important role in addressing the current healthcare challenges. Due to the gradual onset of chronic disease, nutrition and integrative lifestyle treatments are the foundation for preventing and reversing these conditions. Chronic diseases with the highest mortality rate and prevalence in the United States, such as diabetes, cardiovascular disease and cancer, are lifestyle-related health conditions (GBD CKD Collaboration, 2020). However, most primary care providers do not feel confidently equipped with the education, or the time, to provide these recommendations (Clarke et al., 2016). Dietitians use evidence-based and personalized approaches to treat disease by providing cells the nutrients they need to properly function and thrive.

Nutrition education, however, can only play a limited role. Low levels of income and education, as well as access to health insurance and food, are directly correlated with prevalence of chronic disease. The cost of IFMNT, which can include expensive lab tests and supplement regimens, would be a barrier to access for those in lower income groups. Access to insurance and limitations on insurance coverage for nutrition therapy, especially preventive therapy, would make IFMNT an unattractive option of care. Food deserts and food insecurity can limit access to diet changes and nutrition recommendations indicated by IFMNT directed therapies. Therefore, the reader should keep in mind that some aspects of IFMNT therapies are currently less accessible to many of those who need it most, namely the underserved communities who most suffer from chronic disease. To change this requires not only targeted IFMNT for these communities, but also continued efforts to address the systemic inequities in our healthcare system, including addressing universal health insurance, increased coverage for nutritional therapies provided by RDNs, and increased access to healthful foods. This paper focuses specifically on the functional medicine portion of IFMNT as it presents currently, namely the personalized, systems biology-oriented, diagnostic process. This key aspect of IFMNT is already well defined, included under the Academy of Nutrition and Dietetics (AND) umbrella, and providing value. However, the associated diagnostics and MNT have practical limitations for currently underserved communities, particularly cost and access issues.

Introduction: Development of Integrative and Functional Medical Nutrition Therapy

Functional and integrative medicine grew rapidly in popularity starting in 1990s. Functional medicine was born in 1991, with the creation of the Institute for Functional Medicine (IFM), founded by Jeffrey and Susan Bland. Meanwhile, the first training program in integrative medicine was created at the University of Arizona, by Andrew Weil and colleagues, in 1994 (Marian & Mullin, 2017). Interest in integrative and functional medicine naturally spread to nutrition practitioners, due to the important role of nutrition and lifestyle treatments in the approaches. In 1998, a group of RDNs established the Nutrition in Complementary Care DPG, later called Dietitians in Integrative and Functional Medicine (DIFM), as a way to broaden their skill sets in topics like nutritional genomics, functional foods, dietary supplements, Chinese dietary therapy and Ayurveda (Ford et al., 2011).

4 Building upon the Nutrition Care Process and Model, advocates of DIFM developed Standards of Practice (SOP) and Standards of Professional Performance (SOPP) for Registered Dietitians in Integrative and Functional Medicine (Ford et al., 2011). In addition, the conceptual framework called the IFMNT Radial, was created as a model for critical thinking, using science-based ideologies, as well as personalized nutrition care, to identify and treat disease, incorporating conventional and alternative medicine modalities.

DIFM remained active in supporting RDNs practicing IFMNT. In 2014, DIFM surveyed Academy members on integrative and functional nutrition (IFN) practices (Augustine et al., 2016). In 2017, DIFM studied experienced IFN RDN roles and critical thinking (Goodman et al., 2018) and then described the roles and practices of experienced IFN RDNs (Goodman, et al., 2018b). This work led to the new SOP and SOPP for RDNs in Integrative and Functional Medicine (Noland, et al., 2019). Today over 5,500 Academy of Nutrition and Dietetics members participate in the DIFM DPG (DIFM, 2021).

The following sections of this paper provide important definitions, describe functional medicine and its effectiveness, describe the nutrition care process’s application using the radial for IFMNT, identify some of the types of assessments and treatments, explains the role of RDNs, and describes the various research centers, certifying bodies and information sources, and government organizations that play an important role in IFMNT. The paper then discusses some of the critiques and limitations that have been ascribed to integrative and functional medicine and IFMNT, and summarizes the possible impact of RDNs in IFMNT on healthcare and wellness.

Definitions

Functional medicine (FM)- The Institute for Functional Medicine defines functional medicine as a process by which a provider will find how and why an illness is occurring, get to the root cause of the disease, and restore health (IFM, 2021). Complementary and alternative medicine (CAM) - Includes an array of modalities that are not conventionally used to treat disease. Modalities include acupuncture, biofeedback therapy, hypnosis, yoga, tai chi, and meditation (NCCIH, 2021a). Integrative medicine (IM)- combines conventional and alternative therapies, such as FM and CAM, to treat and prevent disease. It focuses on the mental, physical and spiritual aspects of health (NCCIH, 2021a). It incorporates functional medicine approaches while recognizing the importance of nutrition. Integrative and functional medical nutrition therapy (IFMNT)- A type of medical nutrition therapy incorporating integrative and functional medicine practices. Nutrition therapy that follows the nutrition care process providing patient-centered care, looking at food, lifestyle and environment; biomarkers, nutrition physical signs and symptoms; metabolic pathways and networks; and systems to identify and address the root causes of disease (Noland & Raj, 2019).

Functional Medicine

As the annual healthcare expenditure increases consistently, so does the prevalence of chronic disease. The rise in chronic diseases is mirrored by a significant rise in healthcare costs, with seemingly no solution. The current healthcare system and its modalities of treatment have not

5 significantly changed and patients have started seeking treatment outside of the conventional healthcare system. There has been an increase in clinics providing complementary and integrative medicine, including university medical centers.

Conventional medicine uses signs and symptoms to diagnose a patient, and then manages these symptoms, often with pharmaceutical drugs or surgery (Wahls Protocol, 2020). Many times, these pharmaceutical drugs have side effects, exposing the patient to a myriad of possible comorbidities, and without ever getting to the root cause of the original problem. For example, patients with prediabetes are oftentimes preemptively prescribed metformin, without a consult to a dietitian to change diet and lifestyle behaviors that are likely causing the symptoms.

Functional medicine uses an evidence-based, systems biology approach to treat imbalances that occur in the body (Bland, 2019). Each organ system, and the tissues and cells that make up that system, are a structure of interacting networks that influence the function of our bodies over time. Disease occurs on a continuum, with risk of disease rising and falling as our unique set of genes, physiology and behaviors, interact with our environment (Hanaway, 2016).

The principles of functional medicine (Jones, et al., 2010) are:

● Focus on patient/client-centered approach ● Acknowledges biochemical uniqueness of individual ● Seek balance between mind, body & spirit ● Acknowledges that all body systems are interconnected and influenced by physiological and/or metabolic factors ● Identifies health as positive vitality

Functional medicine uses a combination of modalities, allopathic and integrative, to treat imbalances and improve vitality. Analysis of conventional and functional labs and completion of comprehensive patient questionnaires and patient visits, aid the provider in getting to the root cause of an imbalance. Treatment modalities can include diet and lifestyle changes, nutraceutical supplements, and mind body therapies, like qi gong, yoga and meditation (Kalish, 2012).

The root of disease can often come from our diet choices. Food provides our cells nutrients to function properly, and when we are starving our cells of the functional nutrients they need, that is when disease can begin (Wahls, 2020). A study found that the Standard American Diet (SAD) did not meet the recommendations from the Dietary Guidelines for Americans (DGA), with many of the choices being nutrient-poor foods, leading to a population affected by malnutrition and obesity (Grotto & Zied, 2010). Diseases like diabetes, cardiovascular disease, hypertension, and even mental disorders can all be treated with diet, by providing our cells the nutrients they need to function optimally.

The provider-patient relationship is a vital part of the functional medicine practice. Some patients that seek out alternative therapies report not feeling heard by their primary care provider, or feel rushed and dismissed (McCaffrey et al., 2007). Functional practitioners are encouraged to form a therapeutic relationship with their patient, viewing the patient as a person with a unique combination of experiences and stressors that can influence health outcomes. Creating an

6 environment of listening and trust is crucial in a successful patient-provider relationship (Hanaway, 2016).

Effectiveness of Integrative and Functional Medicine

As more patients turn to functional and integrative modalities to treat disease, there has been a continued rise in studies on the efficacy and effectiveness of functional treatments in healing chronic conditions. Functional and integrative medicine has proven useful in the treatment of different health conditions. A retrospective cohort study done by the Cleveland Clinic, measured functional medicine patient’s health-related quality of life (HRQoL) as compared to conventional patients. The study found that, at 6 months, the functional medicine patients had an increase in HRQoL relative to those treated at the conventional clinic (Beidelschies et al., 2019).

Dr. Terry Wahls used the tenets of functional medicine to treat herself, after her diagnosis of multiple sclerosis (MS). Even with conventional treatment, she spent the majority of her day laying in a zero-gravity chair. However, after adopting a largely Paleolithic diet, using supplements to enhance mitochondrial health, and using electrical stimulation therapy, her movement started to come back and she can now walk and even do sports with her family. She created the Wahls Protocol, to help other people with autoimmune disorders treat their conditions through diet, supplementation and lifestyle changes (Wahls Protocol, 2020). Continued studies based on diet therapy for MS are in place, and preliminary studies find that the Paleolithic diet may aid in relieving symptoms of fatigue from MS (Titcomb et al., 2020). Furthermore, other studies are currently underway, looking into diets that are beneficial for MS treatment, looking specifically at gluten-free diets, ketogenic and low-fat diets, intermittent fasting, and vegetarian diets (Chenard et al., 2019).

Functional and integrative therapies can cost less overtime, relative to conventional medicine treatments. A study done at a tertiary care hospital in Minneapolis found that patients receiving treatment with integrative therapies had pain reduction of 2.05 points on average, with a cost savings of $898 per person. Pain was measured on an 11-point, patient-reported scale, after each integrative care session (Dusek et al., 2018). One particular study in the United Kingdom found that if 10% of the population consumed a strictly Mediterranean diet, the estimated savings in healthcare costs over the next 20 years, would be 7.523 billion pounds, around 10.4 billion dollars (Schepers & Annemans, 2018).

In recent years, the treatment for chronic disease has moved toward a personalized approach, using psychology-based techniques like motivational interviewing, to assess the patient's readiness for change to illicit the best outcomes for a patient. Due to its chronic nature, treatment for these diseases can be a lifelong undertaking, and the willingness of the patient to adhere to lifestyle changes is vital. Functional and integrative treatments rely on a close, therapeutic relationship, between patient and practitioner, in which health coaching principles are used. The Duke Integrated Health coaching program conducted a number of studies on the value and effectiveness of coaching, including a type 2 diabetes randomized 6-month trial of 56 patients that showed that barriers to treatment adherence decreased and patient activation, perceived social support and benefit, increased, and patients with significantly reduced their A1C from

7 baseline measurements. A significant strength of the study was the diversity of the patient sample (Wolever et al., 2010).

Certain CAM therapies, like acupuncture, are ancient therapies that have been used for healing for centuries. Recent research has shown the effectiveness of acupuncture, and functional brain imaging showed that the use of acupuncture affected neural networks that are directly involved in how we process pain and regulate emotions (Huang et al., 2012). Another meta-analysis found that acupuncture was more useful in treating and managing pain than standard medical care (Vickers et al., 2012). A systematic review of randomized controlled clinical trials done by the Institute of Medicine (2021), assessed 80 CAM therapies used in integrative oncology. Results found that consistent use of meditation, yoga and relaxation with imagery, helped to improve mood and mental health, and decreased stress. Acupuncture was given a grade B in its effectiveness in helping chemotherapy patients lessen side-effects, including nausea and vomiting. (Greenlee et al., 2014).

In 2011, 25 of 29 integrative medicine centers (86%) conducted research. The multi-million- dollar research programs at the University of Maryland Center for Integrative Medicine and the UCSF Osher Center for Integrative Medicine are both NIH Centers of Excellence for Research (Horrigan et al., 2012). Much of the focus of research is on evidence for integrative medicine, including randomized clinical trials. The Integrative Medicine Program at the University of Texas has conducted randomized controlled trials, incorporating yoga into radiotherapy for women with breast cancer, quality-of-life (QOL) benefits of expressive writing for patients with renal cell carcinoma, and QOL benefits from telemedicine delivered mind-body imagery-based group interventions for breast cancer survivors. Studies found benefits for patient QOL outcomes in each study (MD Anderson Cancer Center, 2021).

At the University of Arizona, the Integrative Medicine Primary Care Trial (IMPACT) considers the Andrew Weil Center for Integrative Medicine’s own integrative primary care model as the intervention. IMPACT analyzed integrative treatment modalities, focusing on nutrition care, acupuncture, health coaching, mind-body medicine and education. IMPACT found that after 1 year of integrative treatment, patients reported beneficial impacts on sleep quality, physical activity, pain, mental, physical and overall health and work productivity (Crocker et al., 2019).

The Nutrition Care Process and the Model for FN/IM and the IFMNT Radial

Medical Nutrition Therapy (MNT) is an effective treatment for many chronic and acute diseases. It is used in the management and care of a myriad of diseases and syndromes, including diabetes, cardiovascular diseases, hypertension, obesity and even acne. MNT was found to significantly reduce HbA1c levels in patients with diabetes, and increases in quality-of-life outcomes were reported in patients with diabetes (Franz et al., 2017). MNT involves a patient-centered care process through an assessment of the patient’s signs and symptoms, a nutrition-related diagnosis, a targeted intervention, followed up by monitoring and evaluating the patient to assess and/or change the intervention as needed, for optimal recovery of the patient.

The IFMNT Radial compliments and builds upon the conventional MNT framework. The radial analyzes five different spheres, food, lifestyle and environment, biomarkers, metabolic pathways

8 and networks, systems, as well nutrition physical signs and symptoms, to best assess what is the root cause of a disorder.

The Food, Lifestyle and Environment sphere looks at many of the social determinants of health, including food access, a safe built environment for exercise and physical activity, spiritual wellness, and stressors including acute and chronic causes due to factors like systemic racism or cultural bias. The main tenet of this domain is using whole, plant-based foods as treatment and prevention of disease, looking specifically at a patient's unique biochemistry and environmental influences (Ford et al., 2011).

The Biomarker sphere will evaluate imbalances found in conventional and functional laboratory results, looking at specific organic acid metabolites, micro and macronutrients, and immune or inflammatory markers to inform a care plan. Certain biochemical assessments used in functional care include an organic acids test, comprehensive stool analyses, such as a PCR test, hormone testing, nutrigenomic screenings and enzyme assays (Cunningham, 2016).

The Nutrition Physical Signs and Symptoms sphere uses data and observations from a nutrition focused physical exam, in-depth patient questionnaire, and patient consultations, to create a picture of the imbalance. Physical signs and symptoms are vital clues in diagnosing the root cause of a patient's ailments, and are used in tandem with information from other spheres to best treat a patient.

The Metabolic Pathways and Networks sphere uses biochemical pathways, to analyze what is going on at a cellular level in the patient. This can include anabolic and catabolic pathways of metabolism, mitochondrial health and function, detoxification pathways, and cellular respiration (Cunningham, 2016). IFMNT evaluates the functionality of the patient's entire biochemical pathways, analyzing metabolites and precursors, to find a dysfunction (Ford et al., 2011). Correcting imbalances at a cellular level, figuring out what metabolic pathways are not functioning optimally, is essential in treatment of disease.

Finally, the Systems sphere correlates the health at a cellular level to the health of the greater organ systems. This assessment can include looking at digestion and absorption, oxidative stress, endocrine systems, and inflammation. An imbalance in one area of the body, possibly due to genetic and environmental factors, can trigger cellular and organ dysfunction. The systems biology approach speaks to the connection of cellular imbalances with physical signs and symptoms. Information gleaned from a nutrition focused physical exam, as well as laboratory results, can paint a picture of how networked organ systems are interacting to create one or multiple disease states in a patient (Ford et al., 2011).

Outside of the spheres, triggering factors are depicted including allergens and intolerances, pathogens, stress and toxins. The spheres come together in the center, to list the mind, earth, body, community and spirit, emphasizing the importance of the holistic mentality in integrative and functional nutrition care.

Types of Assessments and Interventions

9 Integrative and functional RDNs use evidence-based research and clinical data from nutritional evaluations to assess nutrition status and guide the use of a personalized therapeutic dietary approach, including phytonutrient diversity and appropriate supplementation. RDNs use assessment and treatments that complement conventional medicine approaches. The Nutrition Care Process (NCP) is the RDNs guideline for Assessment, Diagnosis, Intervention, Monitoring and Evaluation (ADIME). RDNs practicing NIFM augment the traditional NCP, using a framework like the IFMNT Radial to assess and treat.

The patient’s story is a vital part of assessment and interventions. This comprehensive intake record, provides a detailed history of a patients past medical history, as well as their overall health status throughout their life. This piece of information is especially important in NIFM because of the emphasis of the unique metabolic individuality of each patient. Capturing possible genetic and environmental factors that could be playing into each patient’s story is crucial in discovering the root cause of an imbalance. Moreover, research captured by the Institute for Functional Medicine (IFM) suggests that patients will be more engaged in treatment plans when the patient’s history is patient-centered (IFM, 2021b) so that the patient can describe all of the concepts they consider to be important. (Basch et al., 2011) and feel that the RDN understands their lived experiences (Lasch et al., 2010).

In addition to the IFMNT Radial, other tools have been created to aid RDNs practicing NIFM. IFM designed the Functional Medicine Timeline (IFM, 2021b). The Timeline allows the provider to gain insight into the patient’s previous life events while validating the patient’s experiences. The Timeline is patient-centered and provides a graphical representation that allows clinicians to identify factors that predispose, provoke and contribute to pathological changes and dysfunctional processes in the patient’s physiology.

IFMNT also uses therapeutic food elimination diets, food journals, detoxification programs, medical symptom questionnaires, and dietary supplements to assess and treat patients. CAM modalities like yoga and meditation, can also be incorporated into a patient care plan Ford et al., 2011).

The Nutrition-Focused Physical Exam (NFPA) is a useful assessment tool for RDNs. The NFPA allows the RDN to observe physical signs and symptoms in a patient that can be vital in assessment of root causes. The NFPA is useful in identifying malnutrition, as well as possible micronutrient deficiencies in a patient. The NFPA is a physical examination, used to assess changes in weight, dietary intake, GI signs, as well as possible loss of subcutaneous fat and muscle wasting or edema (Esper, 2015). These findings can be used in combination with anthropometric data and biochemical markers, to provide clues to possible nutrient deficiencies and assess nutrition status.

The ReNew Food Plan, created by IFM and the Cleveland Clinic Center for Functional Medicine, is a food plan that assists the body in eliminating dietary causes of inflammation, and can help identify food sensitivities and remove addictive foods. The goal of the food plan is to stabilize blood sugar and insulin levels and can be used as a tool by functional RDNs to treat patients with autoimmune diseases, fatigue and pain, and other nutritional disorders (IFM, n.d.).

10 Conventional and Functional Labs

The RDN practicing NIFM can perform lab tests to get a clear view of what is causing an imbalance in a patient. Conventional and functional labs are used to assess what is happening in the body at a cellular level. A wide array of assessments are done in a functional clinic to diagnose the root cause of a disease in a patient, including laboratory tests looking at GI function, inflammation markers, nutritional deficiencies, hormonal imbalances, amino acid precursors and metabolites, as well as environmental toxin exposures. Once an imbalance has been identified, a personalized care plan is created for the patient.

GI Testing.

One way that functional nutrition differs from more allopathic training, is the focus on the gut. An unhealthy gut microbiota can translate to neurodegenerative disorders, mental disorders, musculoskeletal disorders and endocrine disorders, to name a few. Many functional practitioners believe that most, if not all, disease can be traced back to the gut. The health and diversity of a patient's microbiota can affect their immune system, hormones, as well as metabolic and digestive health (IFNA, 2021a).

Diet has a direct correlation with inflammation. Seventy percent of the immune system resides in the gut, and when there is a breakdown of the gut barrier due to diets low in fiber and high in sugar and processed foods, it can set the stage for immune dysfunction. Pro-inflammatory diets, like the SAD, increase inflammation in the gut, causing leaky gut. Leaky gut occurs when inflammation increases the permeability of the gut lining, allowing pathogens to get into our blood and travel throughout our body, overactiviating our immune system and overtime, creating dysfunction and disease (IFNA, 2021a).

RDNs can use comprehensive stool tests to analyze the health of the gut and how the state of the gut is influencing a patient's disease state. Polymerase chain reaction (PCR) tests look at the RNA and DNA in a stool sample, and analyze specific biomarkers that can indicate a cause of a disease or imbalance. For example, the measurement and analysis of these biomarkers could show a practitioner if a patient is experiencing malabsorption of nutrients due to increased intestinal permeability from inflammation and continued breakdown of the GI barrier. This malabsorption can influence cell health, and overtime impact organ systems, creating chronic disease (IFNA, 2021a).

Food Sensitivity Testing.

Functional RDNs can use specific tests to measure food sensitivities in patients. A food sensitivity differs from the possibly life-threatening food allergy, and can be more difficult to diagnose in patients, due to delayed expression and gradual onset of symptoms. Food sensitivities occur when particles of a particular food protein enter the body, usually due to increased intestinal permeability. Once the food protein is in the blood, antibodies bind to the antigen, causing a systemic immune response (IFNA, 2021a) A practitioner could test a patient for a possible food sensitivity if the patient presents with symptoms of gas, bloating, fatigue, skin issues, and headaches. Results from this test can indicate a variety of disorders, such as certain

11 autoimmune diseases. Food sensitivity panels look at IgA and IgG antibodies and different food immunoglobulins. One type of food sensitivity test is a Mediator Release Test, that measures the proinflammatory mediators, like cytokines and prostaglandins, released from immune cells. The test measures the change in the number of different types of immune cells to more accurately measure which foods are causing a sensitivity reaction (MRT, 2021).

Organic Acids Testing.

Organic acids tests are useful to provide insight into cell and metabolic health from a biochemical standpoint. It measures different enzyme, cofactor and substrate statues. Enzyme status is a good marker of metabolic health, since enzymes are responsible for many metabolic processes. Enzyme health and efficiency are dependent on our nutrient status, as many vitamins and minerals are used as cofactors in reactions and are essential for enzyme functionality (IFNA, 2021a). The organic acid test is a urine test, directly measuring how many organic acids are found in the urine. An elevated level of the organic acids can signal a block in a metabolic pathway. This can be due to a variety of factors, such as a nutrient deficiency or toxic build up causing enzyme dysfunction (Genova Diagnostics, 2021).

The organic acids test is comprehensive and can be used to look at a number of syndromes and conditions. A provider may use an organic acids test when a patient presents with inflammation, fatigue, chronic stress, mitochondrial dysfunction, diabetes, cardiovascular disease, or anxiety. The test can be used to inform treatment by giving a detailed report of markers of vitamin and mineral status, essential and non-essential amino acids, TCA cycle intermediates and fatty acids (Genova Diagnostics, 2021).

The assessment differs from more conventional tests that look specifically at the serum level of a specific vitamin or mineral. Looking at the end metabolites in urine, the test is measuring that the vitamin or mineral is being effectively utilized in the body. The results show how well the body is functioning at digesting, absorbing and utilizing nutrients at a cellular and metabolic level (IFNA, 2021a).

Environmental Testing.

Environmental testing uses urine and blood tests to assess heavy metal and environmental toxins in the body. Our bodies are constantly being exposed to toxins, from heavy metals, xenobiotics, food preservatives and even from the cosmetic products we put on our skin. Experts estimate our body contains around 300 different chemicals in our blood (CDC, 2009). Our liver, kidneys, and GI tract function to break down these toxins and excrete them, but these systems can become overwhelmed and toxins can build up, leading to adverse health outcomes. Toxins can function as endocrine disruptors, interfering with our hormones, or as neurotoxins, creating symptoms of chronic fatigue, brain fog and immune system suppression (Genuis et al., 2013).

These tests are utilized to evaluate a patient's degree of exposure to environmental toxins and heavy metals. They can be used when a patient presents with unexplained fatigue and an increase in inflammation, or if other tests you have done have turned up inconclusive. Heavy metals, such

12 as cadmium, lead and mercury can cause a wide range of health issues, including neurological, gastrointestinal, and respiratory.

Additional Testing.

Functional nutrition tests also include tests looking at adrenal fatigue, measuring cortisol levels through saliva, as well as tests that look at neurotransmitter levels to give patients with ADHD, mood disorders or sleep dysfunction insight into possible imbalances that can be corrected through supplements and diet. The DUTCH test, is a dried urine test, that provides a comprehensive panel of results on female and male sex hormones, as well as cortisol levels. These tests would be important for patients with questions about adrenal health, hormone imbalances, and infertility issues (DUTCH, 2021).

The tests listed above are just a few of the wide variety of tests a DIFM can offer. Functional nutrition relies heavily on complementary and alternative modalities to treat patients and often refers patients to other integrative and alternative care providers. Integrative, complementary and alternative care provide a plethora of different modalities that can help treat a wide-array of ailments, including chronic diseases.

Role of Dietitians in Integrative and Functional Medicine

One of the modalities of treatment that has fallen through the cracks during the time of pharmaceutical drugs, is diet. Most medical schools do not provide the required nutrition training to their students, and many registered dietitians are underpaid and undervalued (Margolis, 2016). Less than half of US medical schools surveyed taught nutrition in clinical practice, while studies continue to show that poor nutrition and lifestyle factors greatly increase the likelihood of development of chronic conditions (Adams et al., 2015).

A core tenet of functional medicine is using diet and lifestyle to restore health. RDNs practicing IFMNT deliver nutrition care using systems biology, clinical biomarkers, and lifestyle habits as indicators and guides for identifying and treating disease (Noland & Raj, 2019). Principles of RDNs in Nutrition in Integrative and Functional Medicine (NIFM) include highlighting a therapeutic patient-practitioner relationship, examining individual lifestyle, environmental and genetic components of the patient, pertinent use of conventional and complementary treatments, as well as the employment of natural, evidence-based, noninvasive treatments (Noland & Raj, 2019).

Many patients are turning to functional and integrative providers for treatment, creating a rising demand for more functional providers. Integrative and functional medicine relies on a team of healthcare professionals, including a RDN. RDNs are experts in the role of nutrition and diet in health, and can counsel patients in prevention and treatment of disease using IFMNT. RDNs in NIFM cover the fundamentals of nutrition, as well as complete comprehensive patient intakes and sessions, perform lab tests and analyze results, diagnose nutrition problems using expert reasoning and evidence-based protocols and provide patient-centered intervention plans, using motivational interviewing techniques. One main role of NIFM is to plan, create, and provide educational interventions for patients. Certain patients are deficient in nutrients and need to

13 supplement to rebalance the health and efficiency of their cells. NIFM can provide evidence- based education on which supplements are enhanced when taken in the presence of another nutrient, to aid the body in uptake and utilization of that nutrient.

RDNs in NIFM believe that nutrition is not just essential for physical health, but mental and emotional health as well. Studies show the importance of the gut-brain connection, tying specific foods to emotional wellbeing (Mayer et al., 2015) (Hyman, 2009). Furthermore, deficiencies of certain vitamins and minerals, like folate and vitamin B12, have been linked to depression (Coppen & Bolander-Gouaille, 2005). Dietitians are trained in health coaching and use motivational interviewing skills to encourage and support behavior changes in patients (Wolever et al., 2010).

NIFM RDNs use high-quality, plant-based diets, including the Mediterranean diet, in the treatment and prevention of disease. An abundance of studies highlight the importance and effectiveness of plant-based eating in reducing the risk of diseases, including diabetes, cardiovascular disease, and lowering overall mortality, as well as maintaining health of our planet (Hemler & Hu, 2019) (Baden et al., 2019) (Fresan & Sabate, 2019) Plants are nutrient- dense, providing the nutrients our cells need to function optimally. Including more nutrient- dense, plant options into the diet of patients, can reduce the risk of disease, and help to reverse chronic conditions.

Optimal nutrition varies across the lifecycle and an adequate and balanced diet can reduce the risk of disease at every age, while malnutrition can feed disease. (Ozdemir, 2016). RDNs practicing NIFM go a step further, looking at the biochemical role of phytonutrients and antioxidants on metabolic processes. Tests, like the organic acids test, show the effects certain antioxidants and phytonutrients can have on metabolic systems, and the synergistic effect different nutrients have on our health at a cellular level (Lund, 2013). Furthermore, plants and herbs can be utilized for their medicinal functions. Certain foods are anti-inflammatory, such as those high in omega-3 fatty acids, and can be used as treatment and prevention of chronic inflammatory conditions. Herbs, like turmeric, ginger or aloe vera, can be used in place of or with pharmaceutical drug therapies.

RDNs are an integral part of the patient care team and numerous studies have shown the increase in positive patient-health outcomes through lifestyle interventions incorporated in the treatment plan by RDNs. The Look AHEAD study, evaluated the effect of weight loss on patients with type 2 diabetes. The intensive lifestyle intervention, given by a care-team, including RDNs, found that over the 8-year period, 50% of the patients had clinically meaningful weight loss, and greatly improved secondary outcomes, including quality of life, sleep apnea mood and physical function (Look AHEAD Research Group, 2014). The dietitian-led ICAN study demonstrated that moderate-cost lifestyle interventions could ameliorate health indicators in obese type 2 diabetes patients, highlighting the importance of dietitians in health-related outcomes (Wolf et al., 2004). RDNs provide cost-effective therapy in disease treatment. A systematic review and meta- analysis reviewed 34 studies and found that continuous individual, in-person sessions over 3 to 21 months, with a RDN, found improvements in BMI, lipid profiles, fasting blood glucose and A1c levels in patients with dyslipidemia, with economic savings from a reduction in medication use (Sikand et al., 2018).

14

The Standards of Practice (SOP) of NIFM RDNs, state that practitioners must use critical thinking skills and evidence-based dietetic and medical knowledge to provide the best possible care for patients (Noland & Raj, 2019). There are strict competencies needed to provide NIFM services provided by the SOP and SOPP and the Academy, and educational materials, programs and tools are all evidence-based. The DIFM Best Available Evidence Decision Tool helps guide and assist RDNs in finding and assessing available scientific research and the level of evidence for clinical recommendations. The Academy of Nutrition and Dietetics offers a webinar on the five-step evidence-based process for nutrition care (Noland & Raj, 2019).

Lastly, an important and sometimes overlooked role of RDNs is combating nutrition misinformation that is prevalent in today's society. A myriad of health blogs, Instagram accounts, and YouTube channels share information about health and diet, encouraging fad diets and supplements, that are not always backed by science. Many people use forms of complementary and integrative care, like supplements, without telling their healthcare provider. Furthermore, most people do not have the training required to understand which supplements will be the most beneficial, safe and efficacious for their unique body, and oftentimes spend large sums of money on non-targeted treatments that do not yield results (Wansink, 2006).

Registered dietitians are experts in the field, that are trained in evidence-based prevention and treatment of disease using medical nutrition therapy. RDNs practicing NIFM need to be particularly well versed in the use of recommended supplements and herbal treatments. Misinformation in this area of practice can reflect on the credibility of NIFM RDNs and it is in their interest to speak out against certain supplements and fad diets that are suggested without scientific backing.

Organizations Providing Guidance, Knowledge and Support for FN/IM

The credibility and popularity of Integrative Medicine and IFMNT is demonstrated by their certification organizations, by a number of integrative medical centers affiliated by prestigious university medical programs and by the U.S. government organizations adopting the politics (Veterans Affairs) and funding further research (National Cancer Institute and the National Center for Complementary and Integrative Health).

Resource and Credentialing Organizations

While there are many organizations providing Integrative and Functional Medicine resources for RDNs, three of the most influential are discussed below.

Integrative and Functional Nutrition Academy (IFNA).

IFNA provides resources and credentialing to healthcare practitioners, dietetic interns, and students in the medical field. A participant can earn continuing education and training credits. This program is more geared towards nutritionists and dietitians, teaching traditional medical nutrition therapy with integrative and functional therapies and modalities included in the care model, which will be discussed in further detail, below (IFNA, 2021b; IFNA, 2021c).

15

Institute for Functional Medicine (IFM).

IFM provides education, courses and resources for functional medicine practitioners. The coursework is designed for licensed practitioners and eligible degrees range from conventional medical doctors, chiropractors and dentists, to naturopathic doctors, registered dietitians and physical therapists (IFM, 2021c).

IFM provides certification, education and an IFM Toolkit to help practitioners implement functional medicine. IFM considers Functional Nutrition as integral in emphasizing the importance of food quality and adequate nutrition, using this therapy to reverse disease and attain health. IFM is expanding its Functional Nutrition content throughout its curriculum, containing videos with instructions on how to create food plans and do a nutrition focused physical exam, as well a nutrition focused tool kit (IFM, 2021d).

Dietitians in Integrative and Functional Medicine Dietetic Practice Group (DIFM DPG).

DIFM DPG is a practice group of the Academy of Nutrition and Dietetics. There are over 5,500 members who use an integrative and personalized approach to nutrition, health and healing. Integrative Nutrition RDNs recognize each person has their own genetic, biochemical, environmental and lifestyle influences that uniquely impact each person's health status and healing protocol. The group believes that 21st century nutrition practice requires forward thinking professionals that have a wide range of skills in systems biology, nutritional genomics, and dietary supplements (DIFM, 2021).

Functional and Integrative Medical Centers

Many organizations, top medical centers and hospitals have embraced functional and/or integrative medicine. Academic institutions nationwide have adopted integrative strategies. Three top, representative integrative medicine centers in the United States are Duke Integrative Medicine, University of Texas Integrative Medicine Center at MD Anderson Cancer Center and the University of Arizona Andrew Weil Center for Integrative Medicine (Horrigan et al., 2012).

Duke Integrative Medicine.

Duke Integrative Medicine offers a diverse portfolio of clinical services, research and medical education. Personalized health plans, created by an interdisciplinary team of providers, including RDNs, are provided to members of the annual membership program. Duke Integrative Medicine offers pre-and-post-surgery in-patient services, including personalized mind-body sessions, acupuncture, massage, yoga therapy and mindfulness training.

University of Texas Integrative Medicine Center at MD Anderson Cancer Center.

The MD Anderson Integrative Medicine Center uses an evidence-based approach to provide cancer care, as well as knowledge classes for patients and caregivers and a guide to resources on

16 natural products and complementary therapies. The oncology team and integrative health team, including dietitians, work closely together and the center offers mind-body programs, massage and educational sessions (MD Anderson Cancer Center, 2021).

The University of Arizona Andrew Weil Center for Integrative Medicine (AWCIM).

AWCIM is recognized internationally for its educational programs, evidence-based clinical practice and research that substantiate the field of integrative medicine and influences public policy. AWCIM offers integrative healthcare education and research and the Weil Integrative Medicine Library books by Oxford University Press provides students, patients and practitioners access to studies and education on integrative medicine and its treatment on common health conditions. Nutrition plays an important role throughout the series. AWICM participated in the formation of The National Center for Integrative Primary Healthcare, created to address strategies to expand integrative medicine to underserved populations (AWICM, 2021).

U.S. Government Organizations

The National Center for Complementary and Integrative Health (NCCIH).

NCCIH is a U.S. government agency that explores complementary and alternative medicine (CAM). The NCCIH supports a variety of research programs and career development opportunities to aid in increasing the number, quality, and diversity of CAM clinicians. They provide resources to practitioners, including the NCCIH Integrative Medicine Research Lecture series and Herbs at a Glance (NCCIH, 2021b). Each provides research-based information on integrative health modalities, such as information about specific herbs or botanicals and perspectives on integrative health approaches. Materials are also available on dietary supplements.

The National Cancer Institute (NCI).

NCI recognizes complementary and alternative treatments as adjunct therapies to augment allopathic methods. These treatments are encouraged to minimize side effects of cancer treatment, reduce stress, and to treat and even cure cancer (NCI, 2020). The treatments include biologically based practices, such as supplements, botanicals, and special foods or diets. The NCI and NCCIH sponsor clinical trials that test CAM treatments and therapies.

The U.S. Department of Veterans Affairs (VA).

The VA has created the Whole Health Initiative, a program focused on treating the whole person, mind, body and soul, and using complementary and integrative treatments to offer healthcare to veterans. In 2011, 90% of VA facilities offered complementary or integrative therapies. In 2015, the VA learned that mindfulness therapy may be more effective than standard group therapy in treating PTSD (Polusny et al., 2015). VA researchers are committed to critically examining the effectiveness of approaches that have not been rigorously tested through formal research (VA, 2021).

17 Limitations and Critiques of Integrative and Functional Medicine and IFMNT

Although functional and integrative medicine is useful in the prevention and treatment of chronic disease, in its current form, many of these modalities are more likely to be used by individuals with higher income or, level of education and those with adequate health insurance. Because the highest prevalence of chronic diseases in seen among low income, uninsured individuals in underserved communities, the effectiveness of these modalities on the treatment of chronic health conditions will be constrained.

The influence of these social determinants of health are staggering. For each additional year of education, the odds of dying are reduced by 1-3% (Oates et al., 2017). Furthermore, earlier onset and severity of disease, and decreased survival rates are seen in minorities, relative to whites. (Oates et al., 2017). Income and prevalence of chronic disease are inversely related, and as the prevalence of chronic disease rises, the level of income decreases (Dickman et al., 2017). Uninsured Americans with chronic diseases, like diabetes, pay more out-of-pocket for care each year, and over 30% do not have a primary care provider (Dickman et al., 2017). Furthermore, there is a higher prevalence of diabetes in rural populations, and a higher rate or diabetes-related death, which represents the concern of healthful food access in these patient populations (Towne et al., 2017).

Most people agree that eating fruits and vegetables is important for health, however, this does not mean that everyone has access to healthful foods, grown without the use of pesticides. Many patients have practical limitations to the foods they can purchase, monetary or access related. It is reported that about one out of eight American households are food insecure (Castleberry & Wetherill, 2017). Those with food insecurity are at greater risk for metabolic and chronic diseases, due to the calorie-dense, nutrient-low diet typically consumed due to higher availability of processed foods as compared to fresh foods. RDNs can mitigate this problem by implementing oral or written food insecurity screenings, as well as connecting patients with foods banks. However, reducing food insecurity with more uniform access to high quality fresh foods, would make IFMNT interventions more effective.

Integrative and functional medicine care is usually provided through a private outpatient clinic, that may or may not take insurance. Out-of-pocket costs for functional practitioners, usually over $100 per session, are not feasible for every income level, and the health of people in lower income categories is disproportionately affected. Income inequality in the United States is one of the highest in developed countries and wealthier Americans are expected to live 10-15 years longer than low income Americans (Dickman et al., 2017). Even with the Affordable Care Act, around 27 million Americans do not have health insurance and low and middle-income individuals pay more for care (Dickman et al., 2017)

Treatment by a functional medicine provider can be limited to certain groups. IFMNT and personalized nutrition practices, will most likely be used by a population that already has a lower prevalence of chronic disease, namely a population with a higher income to spend on treatments and insurance to cover certain treatments. For IFMNT to be successful, it will have to lower the cost of visits and tests, - through technology development or increased efficiencies in care, or by

18 obtaining more insurance coverage, through incorporation into conventional practices or extended coverage on insurance plans.

These inequities make it clear that any nutrition therapy, including IFMNT, should be evaluated by its effectiveness for groups at an increased risk for chronic health conditions. Practitioners of IFMNT hoping to provide care for these groups could benefit from considering the results of culturally appropriate, community-based lifestyle interventions when designing and delivering therapies. For example, a RCT used the Mediterranean dietary pattern as a treatment to reduce disparities in cardiovascular risk in minority populations in the southeastern U.S. (Keyserling et al., 2016).

For those with the ability to pay or who have applicable insurance coverage, the market for IFMNT is likely to grow due to increasing consumer focus on improving health. Interest in the global wellness industry from consumers and finance industry investors/researchers has grown rapidly (GWI, 2018). Consumer interest in health and nutrition is also growing, as indicated by food industry surveys (IFIC, 2020). The International Food Information Council’s (IFIC) 2020 Food & Health Survey shows an increase in consumer interest on wellness and nutrition, with 54% of all consumers caring more about the healthfulness of their choices, compared to interest in 2010 (IFIC, 2020). Health interest is particularly high in certain groups. Of consumers with a college degree, 85% indicated that they emphasize their overall health a great deal. Forty-five percent of women surveyed reported that their motivation for adopting a new diet was to protect their long-term health and to prevent future health conditions.

This higher level of consumer and investor excitement in personalized nutrition and associated technology has been noticed by financial investment research organizations (GWI, 2019) (Fortune Business Insights, 2020) (McKinsey, 2021). The use of mobile health monitoring devices and apps for food consumption, exercise/physical activity, or overall health, is rising in popularity. App use is 50-100% higher in women, parents, and those with higher income and education, and 66% of app users saying it has led to healthy changes that they otherwise would not have made. Due to the rise in popularity of diet and lifestyle apps, consumers are paying more attention to ongoing innovations like genetic profiling, DNA testing, and gut-microbiome testing.

In the US, demand is shifting towards holistic health management and functional foods and beverages, building on earlier growth in the use of health supplements. The only thing slowing consumers is the current high cost of retail personalized nutrition (Fortune Business Insights, 2020). However, this rapid industry growth and competition may also lead to reductions in personalized nutrition related costs, and could affect IFMNT, including lab tests and supplement costs.

Furthermore, the COVID-19 crisis is causing large numbers of normally stubborn consumers to change their behaviors rapidly. McKinsey expects increased spending on nutrition apps, diet programs, juice cleanses and subscription foods in the wake of COVID-19. In addition, a greater shift towards holistic services such as personal training, nutritionists, and counseling, is anticipated (McKinsey, 2021).

19 This general increase in interest in health and wellness, as well as a specific increase due to COVID-19, IFMNT, with its core tenets of prevention and treatment through personalized, holistic, noninvasive methods, is currently poised to increase in consumer interest. However, without changes in cost or increased insurance coverage, IFMNT will likely remain primarily available to a patient population with higher income, education and access to insurance and healthful foods.

While functional and integrative therapies are rising in popularity in the medical world, there are still naysayers who critique these modalities. David Gorski wrote a review on integrative oncology in Nature Reviews Cancer, citing issues with the practice. He claimed that the majority of integrative therapies are not backed by scientific evidence, and that their efficacy and safety has not been validated. Gorski states that CAM therapies are not well-defined and many times- CAM merely to appropriates and medicalizes mainstream therapies, like nutrition and exercise. He also saw integrative care as blurring the lines between science-based modalities and pseudoscience. Specifically citing the field of acupuncture as a pseudoscience, Gorski claimed that the meridians, or pathways through which energy flows, are a fallacy and that there is no scientific evidence backing their existence (Gorski, 2014).

As demonstrated in this paper, integrative and functional therapies are backed increasingly by science, although not all therapies have sufficient evidence. The U.S. Government funded NCCIH provides numerous informational resources for both IFMNT practitioners and consumers, as well as sponsors clinical trials of integrative and functional therapies. Furthermore, the fact that many integrative and functional medicine organizations are associated with prestigious university research centers (Horigan et al., 2012) notably encourages research on measuring outcomes.

Importantly, a core tenet of integrative and functional nutrition therapy states that the modalities used and recommendations made, are evidence-based and thoroughly studied (Noland & Raj, 2019). As stated earlier, DIFM and the Academy provide tools and databases to help RDNs in their critical thinking and evaluations. A simple examination of the first SOP and SOPP (Ford et al., 2011) and its recent revision (Noland & Raj, 2019) illustrates a significant evolution in the detailed guidance for RDNs practicing IFMNT, particularly in the evidence-based practices of the Nutrition Care Process.

Gorski specifically targeted the efficacy of integrative oncology therapies, but evidence published by the Society for Integrative Oncology clinical guidelines, developed from randomized controlled trials, uses rigorous standards to evaluate the efficacy and safety of these therapies, even creating a grading system as a guide for practitioners who may want to use these therapies (Greenlee et al., 2014). Furthermore, integrative therapies for lifestyle-related diseases, like cancer, provide patients with education and resources for healthful lifestyle modifications, like diet and physical activity, which may improve cancer outcomes (Greenlee et al., 2014).

The field of nutrition has been lacking in high-quality, large clinical trials, in part due to difficulties in dietary assessment methods, pinpointing effects from specific nutrients, and the complex nature of diet (Willett, 2012). Since everyone must eat, there can be no real control group, void of any nutrients and possible nutrient interactions. Diet is dynamic, varying due to

20 food security, seasonal food availability, socioeconomic status, and climate and age. Eating patterns can also change overtime, making direct causal relationships between a specific diet or nutrient and disease difficult (Willett, 2012). Diets are also deeply rooted in culture, and data from one study may not be easily generalizable. Nutrition studies are also not well-funded, compared to pharmaceutical studies, and critics cite the lesser number of conclusive studies to question the importance of diet in treating disease.

Others also criticize CAM techniques as well as the more expensive testing sometimes done as part of functional medicine and IFMNT. Dr. Harriet Hall, a well-known alternative medicine skeptic, claims naturopathic and functional medicine practices have no evidence to back-up their claims (Hall, n.d.). Some critics also claim that the ‘imbalances’ that functional medicine seeks to treat are imaginary, and that the practitioners overcharge for visits and costly supplements (Bellamy, 2013). For many reasons, including the importance of increasing access to underserved communities, IFMNT therapies will most certainly have to become less costly to be widespread and as effective as its advocates claim they can be. However, organizations like the DIFM, IFM and AWCIM are actively trying to address this issue.

Other critiques of the field state that functional medicine plays into the fallacy that everything natural is good for you (Sampson, 2009). Furthermore, Sampson calls into question functional medicine credentialing organizations, like IFM. These critics cite that the organizations have partnerships with supplements and dispensaries that they advertise and encourage their students to use, which can be a conflict of interest, especially if IFM is benefiting financially from these partnerships. (Sampson, 2009). However, many of these critiques are frequently leveled at conventional medicine and the relationships between doctors and “big pharma.” Functional Medicine practitioners are subject to the same malpractice risks as conventional practitioners and it is incumbent on both to aggressively establish evidence-based and cost-effective programs.

Conclusion

The increased prevalence of chronic disease has brought a wave of increased interest in health and wellness. With 42 percent of Americans having multiple chronic diseases and healthcare costs rising, patients are advocating for longevity by looking for alternative modalities and treatment options, outside of conventional methods. Most chronic diseases can be treated and prevented with lifestyle and diet, and there is a growing interest in nutrition and lifestyle- centered, personalized treatment options. With patient’s already ‘opting-in’, functional medicine and integrative therapies are well-positioned to provide personalized and effective treatments for patients. By collaborating more closely with RDNs, providers have the opportunity to marry preventive and personalized medicine focused on lifestyle changes, with clinical care, lowering the total cost of care with better patient outcomes (Hanaway, 2016). Although there are limitations with functional and integrative medicine, the incorporation of functional and integrative modalities into conventional clinical settings through the work of RDNs is a necessary step in reversing the chronic healthcare crisis.

Patients want a wider variety of treatment choices than those offered by conventional medicine, including a greater emphasis on nutrition, as well as complementary and alternative medicine techniques. The functional medicine approach directly targets prevention and treatment of

21 chronic disease and includes nutrition as a central tenet. Functional medicine also includes integrative and CAM techniques as appropriate. Functional nutrition is a cornerstone of the approach to chronic disease treatment and prevention. It is an enhancement of the conventional Nutrition Care Process, representing an advanced practice of the steps of Assessment, Diagnosis, Intervention, Monitoring, and Evaluation (ADIME).

The DIFM dietetic practice group of the Academy of Nutrition and Dietetics, developed the conceptual assessment framework, IFMNT Radial. This framework builds upon integrative and functional medicine concepts. The knowledge and critical thinking of functional RDNs is at the core of IFMNT. It includes a new set of diagnostic tools for addressing chronic disease, as well as looks for core critical imbalances that can be the source for multiple chronic illnesses. This patient-centered, evidence-based approach to treating disease that gets to the root cause, while using comprehensive lab tests and personalized treatment plans. This approach expands and compliments the conventional approach currently taken by RDNs and should be utilized to help solve our continuing health crisis.

While the DIFM approach shows promise in treating and preventing chronic disease, currently it is not accessible to subgroups of the population with the highest prevalence of chronic health conditions. Suggestion for functional and integrative medicine going forward is to push for treatments to be incorporated into the current conventional model, increasing integrative treatments that are commonly used and covered by insurance. The market for nutrition, health and wellness is currently growing and consumer and financier interest is growing. Due to this trend, industry growth and competition in personalized nutrition services could lead to reductions in costs for functional lab tests, as well as supplement treatments and increased likelihood for coverage of DIFM office visits. If so, integrative and functional medicine and IFMNT may yet achieve the promise envisioned by its advocates.

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