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A Randomized, Double-Blind, Placebo-Controlled, Prospective JOURNAL OF MEDICINAL FOOD J Med Food 22 (9) 2019, 875–884 FULL COMMUNICATIONS Mary Ann Liebert, Inc., and Korean Society of Food Science and Nutrition DOI: 10.1089/jmf.2019.0068 A Randomized, Double-Blind, Placebo-Controlled, Prospective Clinical Trial Evaluating Water-Soluble Chicken Eggshell Membrane for Improvement in Joint Health in Adults with Knee Osteoarthritis Susan Hewlings,1 Douglas Kalman,2 and Luke V. Schneider3 1Department of Nutrition, Central Michigan University, Mount Pleasant, Michigan, USA. 2HPD-Exercise Science, Nova Southeastern University, Davie, Florida, USA. 3Department of Chemical and Process Engineering, University of Canterbury, Christchurch, New Zealand. ABSTRACT Osteoarthritis (OA) is a chronic condition that impacts quality of life and functionality for which consumers often seek dietary supplements to provide some relief. The purpose of this double-blind, placebo-controlled clinical trial was to assess the safety and efficacy of a water-soluble chicken eggshell membrane hydrosylate (WSEM) dietary supplement (BiovaFlexÒ) 450 mg daily on knee function, mobility, and general health and well-being in 88 adults with OA randomized into intervention (n = 44) or placebo (n = 44) groups. Outcomes were assessed periodically over 12 weeks, including the Western Ontario McMaster Osteoarthritis Index (WOMAC), the six-minute walk test (6MWT), knee range of motion (ROM) testing, and safety. Normalized analysis (improvement over baseline) showed that the poorest initial performers benefited the greatest from the WSEM by day 5 in the 6MWT, with the rest of the population showing significant improvement over placebo by week 12. The normalized WOMAC Stiffness score was also significantly improved over placebo by day 5 (P < .05). Without normalization, no statistically significant improvements were seen in WOMAC, 6MWT, and ROM testing. The Product was also found to be safe in this study. In conclusion, daily consumption of WSEM significantly enhanced average individual physical capacity (walking distance and ability), reduced stiffness by the fifth day of supplementation with the greatest benefit seen by the most compromised individuals, and was maintained over 12 weeks. A WSEM dietary supplement may offer a safe option for relief from symptoms and increased mobility for those with OA. KEYWORDS: cartilage chondroitin hyaluronic acid collagen glucosamine dietary supplement osteoarthritis water soluble egg shell membrane INTRODUCTION alleviation protocols are prescribed, only half of the patients experience pain reduction.5 Some improvements may be steoarthritis (OA) is a chronic joint condition that achieved by weight-loss and physical activities, including Oaffects millions of people worldwide, with significant physical therapy; however, this often does not lead to a full impact on quality of life, activities of daily living, and health alleviation of symptoms.6 Although surgery is often the only care costs.1–3 According to The World Health Organization option for more severe cases it is not always an option due to (WHO) Global Burden of Disease Study 2010, hip and knee cost or co morbidities.7,8 Therefore, there is a need to in- OA is the 11th leading cause of disability and is predicted to vestigate alternative therapeutics and nutritional supple- increase.4 There is no standard for treatment and what is ments as an option for symptom management. Perhaps one available is typically focused more on pain alleviation by a of the most known nutritional supplement combinations to combination of pharmacological and nonpharmacological be investigated is chondroitin-sulfate, glucosamine, and approaches rather than curative treatment. Even when pain hyaluronic acid.4–6 In a double-blind, placebo-controlled study, subjects taking a herbal extract in combination with Manuscript received 21 May 2019. Revision accepted 18 July 2019. hyaluronate and glucosamine for 8 weeks demonstrated a 9 Address correspondence to: Susan Hewlings, PhD, RD, Department of Nutrition, Central faster return to joint health and greater quality of life. In Michigan University, 1200 South Franklin Street, Mount Pleasant, MI 48859, E-mail: another study, the effect of UP1306, a standardized, pro- [email protected] prietary extract of Morus alba and Acacia catechu, com- # Susan Hewlings et al. 2019; Published by Mary Ann Liebert, Inc. This Open Access pared with glucosamine chondroitin was evaluated in 135 article is distributed under the terms of the Creative Commons Attribution Non- adults with OA of the knee in a randomized, placebo- commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits any noncommercial use, distribution, and reproduction in any medium, provided the original controlled, 12-week study. Similar improvements were author(s) and the source are cited. found for the UP1306 group and the placebo group based on 875 876 HEWLINGS ET AL. the Western Ontario McMaster Osteoarthritis Index (WO- Water-Soluble Eggshell Membrane (WSEM) is a novel, MAC) scales (discomfort, stiffness, and activities of daily patented, water-soluble version of EM (United States Patent living) as well as range of motion (ROM) and distance Numbers: 7,584,909, 8,056,844, 8,197,852, 8,211,477, and walked measures. Degradation of cartilage as measured by 8,425,943) containing naturally occurring collagen, elastin, urinary C-telopeptides of type II collagen was significantly glycosaminoglycans (GAGs), and proteins, which typically less at 12 weeks in subjects given UP1306. The authors are essential for maintaining healthy articular cartilage and suggested that early treatment with UP1306 might act to the surrounding synovium. GAGs, one of the components of prevent joint cartilage damage.10 A pilot clinical trial in- WSEM, are large, linear polysaccharides constructed of vestigated the effect of daily supplementation with oral repeating disaccharide units with the primary configurations hyaluronic acid extracted from chicken combs (Hyal-JointÒ, containing an amino sugar (either GlcNAc or GalNAc) and a Bioberica, Spain). Twenty subjects aged ‡40 years with knee uronic acid (either glucuronic acid and/or iduronic acid). OA (pain for at least 15 days in the previous month, symp- Examples include hyaluronan, chondroitin, dermatan, hep- toms present for ‡6 months, Kellgren/Lawrence score ‡2) arin/heparan, and keratan, some of which have been shown participated in a randomized, double-blind, placebo-controlled to benefit joint health in multiple studies.9–11,13,15–18 trial. Ten subjects received the study product (80 mg/day) In a randomized, double-blind, placebo-controlled cross- and 10 received placebo for 8 weeks. The WOMAC scale over study of 22 adults with joint pain/stiffness, Jensen et al. and a quality-of-life questionnaire (the Short Form-36 [SF- reported that supplementation of 450 mg WSEM (Biova- 36v2Ò]) were administered at baseline and after 4 and 8 FlexÒ) for 4 weeks led to a significant improvement in weeks of treatment. The results for subjects in both groups quality of life, physical function,18 ROM of the shoulder showed statistically significant improvements in WOMAC (P < .01), neck, spine, hips, and knees compared with placebo Pain, Stiffness, and Physical Function subscales, and in the (P < .05). Physical activity levels were significantly higher aggregate WOMAC score, with higher magnitudes of change after WSEM than after placebo consumption (P < .05). Sub- in the treatment group for WOMAC Physical Function and group analysis of those who participated in the study in the Total symptoms. Within-group changes indicated signifi- winter season showed improvement of lower back pain af- cant improvement for both groups on the SF-36v2 at 4 and 8 ter 5 days of WSEM consumption compared with placebo weeks; greater change occurred in the treatment group for consumption (P < .05).17 These findings demonstrated ef- bodily pain and social functioning. The results indicated ficacy of the intervention, deserving continued exploration that daily supplementation with oral hyaluronic acid from and follow-up. a natural extract of chicken combs was useful in enhanc- Therefore, to further evaluate the WSEM product, this ing several markers of quality of life in adults with OA of randomized, double-blind, placebo-controlled trial was un- the knee.11 dertaken, specifically in adults who were experiencing symp- Eggshell membrane (EM) is a naturally rich source of toms associated with OA of the knee to the extent that it was combined protein, elastin, collagen, glucosamine, chondroi- impacting quality of life, yet not severe enough to warrant tin, and hyaluronic acid and has been studied as a treatment prescription medication. for management of symptoms related to OA. EM’s high content of bioactive components, as well as properties of moisture retention and biodegradability, suggests that it MATERIALS AND METHODS has potential use for clinical,12 cosmetic, nutraceutical, and Study design nanotechnology applications.13 Studies have demonstrated that EM leads to a reduction in the production of pro- This was a randomized, double-blind, placebo-controlled, inflammatory cytokines, such as interleukin-1 beta and tu- parallel-design, prospective study conducted at a single re- mor necrosis factor-alpha both in vitro14 and in vivo.15 EM search site located in Springfield, Missouri, USA (QPS- has been shown to improve recovery from exercise-induced BioKinetics). The purpose of the study was to assess the joint pain (day 8), decrease stiffness (day 4), and reduce safety
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