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| Name | Class |
|---|---|
| People Science | UNKNOWN |
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This study evaluates the effect of two different doses of a consumer-grade product, MyCondroâ„¢, 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.
This decentralized, consumer-driven clinical study is designed to evaluate the impact of two different doses of MyCondroâ„¢, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 300 mg | Experimental | Participants in this arm will receive a 300 mg daily dose of the supplement, administered as two capsules every morning after breakfast for a 12-week period |
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| 600 mg | Experimental | Participants in this arm will receive a 600 mg daily dose of the supplement, administered as two capsules every morning after breakfast for a 12-week period |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyCondro 300mg | Dietary Supplement | This is a non-animal Chondroitin sulfate formulation. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| MyCondro's effectiveness | To evaluate the effectiveness of two different doses of MyCondro on mobility, activity, and joint health by measuring the change in total WOMAC scores from baseline to the end of the study within each dose group | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Symptoms and Physical Function | This outcome evaluates the product's effect on overall joint health and mobility. Efficacy is measured by tracking the change from baseline in both the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)-assessing pain, stiffness, and physical function-and the TLKS (Tegner Lysholm Knee Scoring Scale). Data will be collected at 1 month, 2 months, and the end of the study to compare improvements within and between the two dose groups. |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity via wearable device | This outcome evaluates the study product's impact on real-world, daily physical activity. By utilizing a health tracking wearable device, study investigators will continuously measure the change from baseline in objective activity levels for each dose group. This allows for a direct comparison of actual physical movement and exertion between the two doses throughout the study period. |
Inclusion Criteria:
Exclusion Criteria:
Any potential participants will be excluded if they meet any of the following criteria:
Technology Limitation: Do not have a personal smartphone, lack internet access, or are unwilling to download the Chloe app.
Concomitant Therapies
Other Illnesses or Conditions
Allergies and Intolerances
General Compliance
1- Unlikely for any reason to be able to comply with the trial, or considered unsuited for participation in the study by the Principal Investigator.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victoria Oyedokun, PhD | Contact | +4915163496903 | v.oyedokun@gnosis.lesaffre.com | |
| Yann Fardini, PhD | Contact | y.fardini@gnosis.lesaffre.com |
| Name | Affiliation | Role |
|---|---|---|
| Noah Craft, MD, PhD | People Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| People Science | Recruiting | Los Angeles | California | 90045 | United States |
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| ID | Term |
|---|---|
| C537847 | Noonan syndrome 3 |
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| MyCondro 600mg |
| Dietary Supplement |
This is a non-animal Chondroitin sulfate formulation. |
|
| 14 weeks |
| Knee pain at rest and in motion | This objective specifically assesses the product's impact on acute and chronic pain levels during different physical states. Utilizing a daily numeric rating scale (NRS), the investigators will track the change from baseline in average weekly knee pain scores-both at rest and in motion-comparing the outcomes between the two dosage groups. | 14 Weeks |
| Subjective Impression of Improvement | This measure captures the participant's personal perception of their symptom relief and overall disease activity. It calculates the change from baseline in the average PGADA (Patient Global Assessment of Disease Activity) score at 1 month, 2 months, and the end of the study to determine if either dose group experiences a more noticeable subjective improvement. | 14 weeks |
| Overall Quality of Life | This objective examines the broader, holistic impact of the study product on a participant's daily living and well-being. By comparing baseline Short Form 36 (SF-36) health survey scores to those collected at the study's conclusion, the study investigators can analyze changes in general quality of life between the two doses. | 14 weeks |
| Systemic Inflammatory Blood Markers | This objective investigates the physiological effects of the study product on underlying inflammation. The study investigators will measure the change from baseline in high-sensitivity C-reactive protein (hs-CRP) levels at the end of the study to evaluate and compare the biochemical impact of the two different doses. | 14 weeks |
| Reliance on Rescue Medications | This outcome tracks the ongoing need for supplementary pain relief during the trial. It evaluates the frequency of standard rescue medication use (paracetamol/acetaminophen and oral NSAIDs) during the product use period. This metric tracks the ongoing need for supplementary pain relief, and differences in usage between the dose groups via a daily diary. | 14 weeks |
| Safety and Tolerability | This critical measure ensures the study product is safe for consumer use at both the 300mg and 600mg dosages. The study team will track and assess the number, frequency, and severity of all adverse events (AEs), serious adverse events (SAEs), and any trial withdrawals caused by AEs throughout the duration of the product use period. | 14 weeks |
| 14 weeks |
| Participant Experience and Study Design Feedback | This objective focuses on gathering actionable insights to optimize future decentralized, consumer-driven clinical trials. The study team will evaluate the results of a participant satisfaction survey to assess the overall study experience, specifically focusing on the usability, design, and effectiveness of the app-based data collection tools used during the trial. | 14 weeks |