Daily intake of a keratin-based dietary supplement may provide relief for the symptoms of knee osteoarthritis, suggest results of a clinical trial published in the Journal of Dietary Supplements .
A daily dose of the Cynatine FLX-branded product (Roxlor LLC, Wilmington, DE) for 60 days was associated with significant reductions in pain and stiffness, report scientists from CB Food Consulting LLC (Salt Lake City), the University of British Columbia (Vancouver), and Roxlor.
While a large placebo effect was also observed by the researchers, they state that this was expected and similar to other reports in the literature for osteoarthritis studies.
“A significant placebo effect is reported in osteoarthritis studies, especially for pain,” they wrote. “It is noteworthy that subjects randomized to Cynatine FLX presented with a greater severity of disease than those randomized to placebo.
“Cynatine FLX acted faster, within six days, for both pain and stiffness scores, and showed a higher reduction in mean total pain score for both WOMAC and SF-36. Cynatine FLX improved symptoms faster (less than seven days) across the board than the subjects on placebo treatment.”
The study was funded by Roxlor LLC and the company provided the supplements for the study.
Building the science
Robert Veghte, general manager of Roxlor and co-author of the study, told NutraIngredients-USA that the new study adds human clinical science to the already existing animal and in vitro science.
“The product is definitely known better in the marketplace for its internal beauty aspects (even though the joint application has been around for longer) but there are a number of products with it on the shelf,” he said. “The companies who use it get great response from their customers as it does work and works quickly.”
According to the study authors, the ingredient is a unique type of protein called keratin, by proprietary processing of New Zealand sheep wool.
“This novel ingredient is stable over a wide range of pH and under conditions of elevated temperature. It stimulates proteoglycan synthesis to prevent joint breakdown and to build joint polymers, thereby increasing shock absorption,” they added. “It is a natural, non-allergenic alternative to many other consumer health ingredients, including glucosamine and chondroitin, and requires no stabilizers such as sulfate or hydrochloride.”
To investigate the ingredient’s potential for joint health, the researchers recruited 50 men and women with knee osteoarthritis to participate in their randomized, double-blind, placebo-controlled clinical trial.
Participants were randomized to receive either the keratin supplement (500 mg per day) or placebo (maltodextrin) for 60 days.
Using the WOMAC Osteoarthritis Index, the results showed that, for pain, the keratin ingredient was associated with average improvements of 13% after six days, compared to 0.73% in the placebo group.
After 30 days, both the active and placebo groups showed significant improvements in pain measures, said the researchers, but the improvements in the Cynatine FLX group were almost twice those of placebo compared to baseline. No significant differences between the groups were observed after 60 days.
Similar results were observed for stiffness. After six days, the group taking the keratin supplements experienced a statistically significant 19.4% reduction in stiffness, compared to a non-significant 4.9% change in the placebo group.
After 30 days, the researchers found that both groups had significant improvements in stiffness measures, and there were no significant differences between the groups were observed after 60 days.
“The results of this study indicate that a study with larger subject population stratified by osteoarthritis severity is needed,” wrote the researchers. “Results from the Framingham osteoarthritis Knee Study also suggest that knee osteoarthritis is more prevalent throughout the older female population and thus a sub-analysis on the female population should be considered in the future.
“As Cynatine FLX contains cysteine and this amino acid has been found to increase the antioxidant glutathione and reduce malondialdehyde (MDA), these two antioxidants could be used as biological markers of oxidative stress in future studies on osteoarthritis with Cynatine FLX.”
Source: Journal of Dietary Supplements
September 2013, Volume 10, Number 3, Pages 184–194
“A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Investigate the Effect of Cynatine FLX on Symptoms of Osteoarthritis”
Authors: C. Beer, S. Wood, R.H. Veghte