NCT07493239

A Decentralized Clinical Study Evaluating the Effectiveness of Two Different Doses of MyCondro™ on Physical Mobility and Joint Health

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Lesaffre International · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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 blood markers (CRP), alongside objective digital metrics of physical activity tracked via wearable devices. Because this research utilizes a direct-to-consumer model-where participants make an informed choice to enroll and collect data at home without a traditional doctor-patient relationship-the findings will provide highly relevant, real-world knowledge regarding the product's tolerability and efficacy to guide the formulation and design of future studies. The double-blind study spans up to 20 weeks, encompassing a screening period, randomization and shipping, a baseline phase, and a 12-week product use period. Eligible participants are randomly assigned to receive either a 300mg or 600mg dose of the study product, with the investigators, study team, and participants remaining blinded to the group assignments. All trial activities are conducted remotely using the Consumer Health Learning and Organizing Ecosystem (Chloe) app by People Science. Through this web-based platform, participants will securely submit demographic data, medical history, and patient-reported outcome surveys. By combining these app-based questionnaires with at-home blood sample collection kits and wearable health tracking technology, the study aims to successfully and safely capture comprehensive health data entirely within the participant's home setting.

Conditions

• Joint Health

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	MyCondro 300mg	This is a non-animal Chondroitin sulfate formulation.
DIETARY_SUPPLEMENT	MyCondro 600mg	This is a non-animal Chondroitin sulfate formulation.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-10-05
• Completion: 2026-11-02
• First posted: 2026-03-25
• Last updated: 2026-03-25

Locations

1 site across 1 country: United States