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The Effect of Crocin Supplementation on Glycemic Control, Insulin

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The Effect of Crocin Supplementation on Glycemic Control, Insulin Behrouz et al. Diabetol Metab Syndr (2020) 12:59 https://doi.org/10.1186/s13098-020-00568-6 Diabetology & Metabolic Syndrome RESEARCH Open Access The efect of crocin supplementation on glycemic control, insulin resistance and active AMPK levels in patients with type 2 diabetes: a pilot study Vahideh Behrouz1, Ali Dastkhosh1, Mehdi Hedayati2, Meghdad Sedaghat3, Maryam Sharafkhah4 and Golbon Sohrab1* Abstract Background: Crocin as a carotenoid exerts anti-oxidant, anti-infammatory, anti-cancer, neuroprotective and car- dioprotective efects. Besides, the increasing prevalence of diabetes mellitus and its allied complications, and also patients’ desire to use natural products for treating their diseases, led to the design of this study to evaluate the ef- cacy of crocin on glycemic control, insulin resistance and active adenosine monophosphate-activated protein kinase (AMPK) levels in patients with type-2 diabetes (T2D). Methods: In this clinical trial with a parallel-group design, 50 patients with T2D received either 15-mg crocin or placebo, twice daily, for 12 weeks. Anthropometric measurements, dietary intake, physical activity, blood pressure, glucose homeostasis parameters, active form of AMPK were assessed at the beginning and at the end of the study. Results: Compared with the placebo group, crocin improved fasting glucose level (P 0.015), hemoglobin A1c (P 0.045), plasma insulin level (P 0.046), insulin resistance (P 0.001), and insulin sensitivity= (P 0.001). Based on the= within group analysis, crocin led= to signifcant improvement= in plasma levels of glucose, insulin,= hemoglobin A1c, systolic blood pressure, insulin resistance and insulin sensitivity. The active form of AMPK did not change within and between groups after intervention. Conclusions: The fndings indicate that crocin supplementation can improve glycemic control and insulin resistance in patients with T2D. Further studies are needed to confrm these fndings. Trial Registration This study has been registered at Clinicaltrial.gov with registration number NCT04163757 Keywords: Crocin, Diabete, Glycemic control, AMPK, Insulin resistance Background Diabetes has become a critical health issue throughout the world and one of the leading causes of disability, mor- bidity and mortality. Despite advances in knowledge and therapeutic approaches, signifcant challenges associated *Correspondence: [email protected] with management of diabetes remain [1, 2]. Increased 1 Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research incidence of diabetes mellitus along with insufciency Institute, Shahid Beheshti University of Medical Sciences, West Arghavan of the Conventional antidiabetic medications in man- Street, Farahzadi Blvd., P.O. Box:19395-4741, Tehran, Iran agement of disease have led to the search for alternative Full list of author information is available at the end of the article © The Author(s) 2020. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creat iveco mmons .org/licen ses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creat iveco mmons .org/publi cdoma in/ zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Behrouz et al. Diabetol Metab Syndr (2020) 12:59 Page 2 of 9 strategies for diabetes treatment [3]. Changes in lifestyle Participants were recruited from the Imam Hossein behaviors and dietary habits have immensely contributed Hospital in Tehran, Iran, from January to June 2019. to the prevention and treatment of diabetes mellitus. Te Te study protocol was explained for eligible subjects, efects of some dietary components on amelioration of and written informed consent was signed by all patients diabetes have been shown previously [1, 4–7]. if they agreed to participate in the study. Participants Crocin, a phytochemical component, is the main bio- could withdraw from the study by their own decision active constituent of Crocus sativus linne (safron) and without any penalty. Gardenia jasminoides [8]. It is a water soluble carot- Tis trial was performed in patients aged between 30 enoid compound and has the structure as an ester of and 70 years, with a clinical diagnosis of diabetes melli- disaccharide gentiobiose with dicarboxylic acid crocetin tus (1–10 years) according to Standards of Medical Care [9, 10]. Crocin possesses a wide range of pharmacologi- in Diabetes Guidelines (American Diabetes Association) cal and therapeutic properties including anti-oxidant or [27], body mass index (BMI) between 18.5 and 30 kg/ radical scavenger, anti-infammatory, anti-cancer, anti- m2, and also the use of oral hypoglycemic agents for con- depressant, neuroprotective and cardioprotective efects trolling diabetes. Participants who took insulin, herbal [11–16]. Tere are evidence demonstrating that crocin and/or nutritional supplements, glucocorticoids, and has protective efects against diabetes mellitus, hyper- non-steroid anti-infammatory drugs within 3 months lipidemia, metabolic syndrome and obesity [17–22]. before the start of the study and during the study were In animal model, crocin showed signifcant and dose- excluded from the study. Other major criteria for exclu- dependent antihyperglycemic and antioxidant activi- sion were clinically diagnosed chronic diseases such as ties in diabetic rat [23]. Shirali et al. reported that crocin renal, hepatic, cardiovascular, autoimmune or any kind of improved insulin sensitivity and serum glycemic pro- infammatory diseases, being pregnant or lactating, being fle in animals with diabetes and modifed lipid profle on a weight loss diet within last 6 months, and having through enhancing insulin receptors sensitization [24]. uncontrolled diabetes (HbA1c ≥ 8.5%). Further, crocin has been shown to prevent elements of metabolic syndrome in rats via enhancing adenosine monophosphate-activated protein kinase (AMPK) [17]. Randomization and treatment Activation of AMPK by pharmacological or natural A total of 112 patients were assessed for eligibility for agents may reverse the metabolic abnormalities associ- inclusion in the trial. Fifty-seven of 112 subjects met ated with diabetes mellitus [25, 26]. the inclusion criteria, seven of whom were reluctant to Current evidence supports the hypothesis that crocin attend (consort diagram, Fig. 1). Patients were selected can play an imperative role in the management of dia- using a simple sampling procedure and stratifed (1:1) betes mellitus and allied complications such as oxidative into two groups based on their sex and age, they were stress and infammation. Despite these promising results, randomly allocated to receive either the crocin supple- to the best of our knowledge, no randomized clinical trial ment (n = 25) or the placebo supplement (n = 25) for to date has been designed to show the efect of crocin 3 months. Randomization sequence was computer-gen- supplementation on diabetes mellitus. Tis study evalu- erated by a blinded biostatistician who was not involved ated the hypothesis that crocin supplementation would with recruitment, using permuted block randomization efectively improve metabolic abnormalities, and acti- (block size 4) and given to the interviewer. Patients were vate AMP-activated protein kinase when given orally to randomly assigned to the trial groups in accordance with patients with diabetes mellitus. the randomization list (code letters A or B) in chrono- logical order. All investigators, staf related to the care of Methods and materials the patients, and participants were blinded to the treat- Study design and participants ment assignment until the fnal statistical analysis was Tis study was a randomized, double-blind, single- completed. center, parallel-group, controlled clinical trial. Te Te intervention group was administered orally 2 research protocol was approved by the Ethics Com- tablets of 15 mg crocin (Samisaz CO., Mashhad, Iran), mittee of the National Nutrition and Food Technol- and the control group was given two tablets of placebo ogy Research Institute at Shahid Beheshti University of (starch), with main meals (breakfast and dinner), for Medical Sciences (IR.SBMU.nnftri.Rec.1398.009). Tis 12 weeks. Placebo tablets were similar to the crocin sup- trial was registered at Clinicaltrial.gov under the iden- plements in terms of the size, color, shape, smell and tifcation number: NCT04163757 and has been car- distribution bottles. Crocin was extracted from safron ried out in accordance with Te Code of Ethics of the stigmas using crystallization method with a purify more World Medical Association (Declaration of Helsinki). than 97%. Behrouz et al. Diabetol Metab Syndr (2020) 12:59 Page 3 of 9 Fig. 1 The study consort fowchart Sample size
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