Susan Hewlings, Douglas Kalman, and Luke V. Schneider
Department of Nutrition, Central Michigan University, Mount Pleasant, Michigan, USA.
HPD-Exercise Science, Nova Southeastern University, Davie, Florida, USA.
Department 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
(BiovaFlex) 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