A Randomized, Double-blind Study Evaluating the Effectiveness of Two Different Doses of MyCondroTM on Physical Mobility and Joint Health Using Participant-Reported Outcomes in Individuals With Self-Reported Mobility Issues Associated With Knee Osteoarthritis
Lesaffre International
Summary
This study evaluates the effect of two different doses of a consumer-grade product, MyCondro™, on individuals experiencing mobility issues related to knee osteoarthritis. The primary goal is to measure improvements in overall joint health and mobility by tracking changes in participants' total WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) scores from the beginning to the end of the trial. Additionally, the study aims to assess secondary outcomes, including the product's impact on pain, stiffness, knee function, patient-reported improvement, inflammatory blood markers (CRP), and daily physical activity.
Description
This decentralized, consumer-driven clinical study is designed to evaluate the impact of two different doses of MyCondro™, a consumer-grade product, on physical mobility and joint health in adults aged 45 and older with self-reported knee osteoarthritis. The primary objective is to assess the change from baseline in the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score within each dose group by the end of the trial. Secondary objectives will measure the product's effect on pain, stiffness, knee function, subjective impression of improvement, and inflammatory bl…
Eligibility
- Age range
- 45+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Individuals age 45 years and older. * BMI range between 18-35 kg/m². * Self-reported mobility issues, including mobility impairment and joint discomfort associated with a known diagnosis of Knee Osteoarthritis. This impairment and discomfort must have persisted for at least 6 months prior to randomization and have been actively experienced within the last 3 months. * Willingness to avoid high Chondroitin Sulfate-containing foods (i.e., animal cartilages, bones, or derivatives such as gelatin) for the duration of the study period. * Willingness to refrain from supplements…
Interventions
- Dietary SupplementMyCondro 300mg
This is a non-animal Chondroitin sulfate formulation.
- Dietary SupplementMyCondro 600mg
This is a non-animal Chondroitin sulfate formulation.
Location
- People ScienceLos Angeles, California