Research

InterHealth paves the way for future joint health research with positive healthy-subject study for UC-II

29-Oct-2013
Last updated on 29-Oct-2013 at 17:02 GMT - By Stephen DANIELLS
InterHealth paves the way for future joint health research with positive healthy-subject study for UC-II
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A daily dose of InterHealth’s UC-II, an un-denatured type II collagen, may boost joint comfort in healthy individuals who only experience discomfort with exercise, according to a clinical trial with implications for substantiating nutraceutical efficacy in healthy subjects.

A daily 40 milligram dose of UC-II for 120 days led to improved knee joint extension and could potentially lengthen the period of pain-free strenuous exertion in healthy adults, according to findings published in the Journal of the International Society of Sports Nutrition.

In addition, scientists from InterHealth Nutraceuticals and Medicus Research LLC associated the outcome with a physiological mechanism of action, with the effects of the supplements linked to activation of T regulator cells, which then down-regulate a number of pro-inflammatory processes.

“UC-II is a unique ingredient that supports healthy joints,” wrote the researchers. “Previous studies have focused on the efficacy of this ingredient in osteoarthritis subjects. By including healthy subjects in this study, and using non-disease endpoints as a measure of efficacy, it is believed that the benefits that derive from UC-II usage now extends to include healthy individuals.”

Key to success

While many joint health studies focus on people with osteoarthritis or rheumatoid arthritis, the new study only included health subjects.

“Using healthy subjects who may be at risk for future joint issues, but who do not present with diagnosable disease, not only helps substantiate dietary supplement structure/function claims, but is in alignment with FDA and FTC enforcement of DSHEA,” explained the study’s principal investigator, Jay Udani, MD, CEO of Medicus Research.

Dr Jay Udani, Medicus Research, explains the study principles in an interview with NutraIngredients-USA at SupplySide West 2012

Dr Udani added that he believes the key to the success of this research in the dietary supplement industry is the population group used in the study. Click here to watch Dr Jay Udani present the principles of designing a clinical trial for healthy populations.

“This healthy-subject study, which excluded individuals with arthritic disease, could be the basis for future research in the joint-health category,” added James Lugo, PhD, VP of Business Development and Research for InterHealth, and lead author of the paper.

“With this publication, we hope to pave the way for future research that promotes not only InterHealth’s ingredients, but the industry’s growth as well.”

A poster presenting results of the 17-week randomized, double-blind, placebo-controlled study with 55 participants took first place at the 2013 Scripps Natural Supplement Conference earlier this year.

Study details

Drs Udani and Lugo and their co-workers recruited 55 people to participate in their randomized, double-blind, placebo-controlled study. Participants were randomly assigned to receive either placebo or UC-II for 120 days. Dr Lugo explained that 40 mg is the standard dose of UC-II.

Results showed that the UC-II group had statistically significant improvements in average knee extension compared to both the placebo group and to their values at the start of the study.

In addition, participants in the UC-II group could exercise for longer before experiencing any initial joint discomfort at day 120 during a strenuous stepmill exertion, compared to the levels at the start of the study.

At the end of 120 days, data also showed that five individuals in the UC-II group (21%) said they did not experience any pain during or after the stepmill protocol, compared to one subject in the placebo group (5%).

“We show for the first time that UC-II can improve joint function in healthy subjects undergoing strenuous physical exercise,” wrote the researchers. “This observation, when considered in context with normal chondrocyte [cells in healthy cartilage] physiology, suggests that activated T regulator cells, specific for undenatured type II collagen, home to an overstressed knee joint where their release of the anti-inflammatory cytokines, IL-10 and TGF-beta reverse the catabolic changes caused by strenuous exertion.”

‘World-class research’

“This healthy-subject study, which excluded individuals with arthritic disease, could be the basis for future research in the joint-health category,” - Dr James Lugo, InterHealth

The study was welcomed by InterHealth CEO, Paul Dijkstra. “Studying active, healthy individuals expands the joint health market to include younger individuals who may be interested in extending a healthy lifestyle,” he said.

“The healthy subject research demonstrates InterHealth’s commitment to the scientific development and global expansion of UC-II. World-class research is an invaluable resource supporting the growth of new and existing UC-II business in the United States and worldwide.”

UC-II, a patented form of undenatured type II collagen derived from chicken sternum, holds novel foods status in Europe.

Source: Journal of the International Society of Sports Nutrition
2013, 10:48 doi:10.1186/1550-2783-10-48
“Undenatured type II collagen (UC-II(R)) for joint support: a randomized, double-blind, placebo-controlled study in healthy volunteers”
Authors: J.P. Lugo, Z.M. Saiyed, F.C. Lau, J.P. Molina, M.N. Pakdaman, A.N. Shamie, J.K. Udani

Related topics: Research, Proteins, peptides, amino acids, Bone & joint health