A few months ago, Vedic Lifesciences, a food supplement CRO, proclaimed that it has been recruiting for joint health studies. Its CEO, Jayesh Chaudhary, explained that “Joint health studies always contribute to about 15% of our overall business. However, this year is something different. We can safely say that claim substantiation studies for joint and bone health supplements are here to stay.” He further added that “Supplement companies are constantly looking for functional ingredients that are not only fast acting on areas such as joint pain and stiffness, but can also help with joint degradation markers on moderate-intensity aerobic exercise.” The organization announced that preclinical and clinical studies outcomes were used for regulatory submissions such as Health Canada and New Dietary Ingredient applications.
“Today, while most joint products rely on data from condition-specific studies, we have seen keen interest in healthy volunteers’ clinical trials,” stated Shalini Srivastava, Director of Clinical Development. He elucidated that their studies are a unique blend of sports-related results like treadmill exercise protocols and joint function measures like Range of Notion and WOMAC scores. The Vedic Lifesciences operations team explained that it had been recruiting extensively during the pandemic. In fact, for some research, the team validated the effect of several factors that affect joint pain and the overall quality of life. This outcome was achieved by statistically analyzing the data from volunteers recruited before and after the first lockdown.
While the recruitment for joint health studies has some challenges, such as placebo response and compliance, the company adopted placebo run-in periods, multi-center recruitment, and interim analyses to ensure the highest data quality. In the first quarter of 2021, Vedic Lifesciences completed two massive osteoarthritis studies for supplement companies in Australia and China, respectively. The 200-volunteer study was dose-finding research to establish the effect of a novel ingredient on joint pain and functionality through the WOMAC scores, quality of life, use of rescue medication, and serum markers of joint inflammation and structures like Interleukin-6 and C-reactive protein. The second 90-volunteer research compared the 12-week effects of popular functional ingredients on WOMAC scores against glucosamine and chondroitin.
Vedic Lifesciences is currently recruiting for its most comprehensive osteoarthritis study. It is 336-days research that will measure the effects of a Health Canada approved branded ingredient on the transformation in joint space narrowing (JSN) in the tibiofemoral joint of the knee. The measurement will be done by magnetic resonance imaging (MRI) as compared to placebo. It will also evaluate the change in diagnostic and prognostic markers of cartilage degradation such as cartilage oligomeric matrix protein (COMP) and treatment responders as analyzed by Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index. Studies show that as people age, they are likely to require joint health supplements. However, clinical trials must be conducted to compete with NSAIDs and analgesics that offer fast onset of action and sustained relief from pain.