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RecruitingNot ApplicableNCT07493239

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

Sponsor

Lesaffre International

Enrollment

240 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

Joint Health

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.

Eligibility

Min Age: 45 Years

Inclusion Criteria10

  • 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 containing Chondroitin Sulfate for the duration of the study period.
  • Able to read and understand English.
  • Able to read, understand, and provide informed consent.
  • Able to use a personal smartphone device and download the Chloe by People Science app.
  • Able to receive shipments of the product at an address within the United States.
  • Able to complete study assessments over the course of up to 16 weeks.

Exclusion Criteria20

  • 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
  • Use of a Chondroitin Sulfate supplement in the 3 months prior to randomization.
  • Current use of other joint health supplements (e.g., glucosamine, hyaluronic acid, collagen peptides) for at least 4 weeks prior to randomization.
  • Use of any intra-articular or intravenous steroid injections in the last 3 months.
  • Receiving any investigational therapies or treatments within 30 days prior to randomization.
  • Other Illnesses or Conditions
  • Self-reported inflammatory arthropathies, such as Rheumatoid Arthritis, Gout, and Infectious Arthritis.
  • Significant systemic lung, liver, heart, or kidney disease (excluding hypertension).
  • Prior history of knee surgery within 3 months preceding the study period, or planned knee surgery (including arthroscopy) during the study period.
  • Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder.
  • Currently pregnant, planning to become pregnant in the next 20 weeks, or breastfeeding.
  • Presence of a knee prosthesis.
  • Any significant illness, disease, or condition which, in the opinion of the Principal Investigator, may impact the ability to participate in the study or impact the study outcomes.
  • Allergies and Intolerances
  • Known hypersensitivity or previous allergic reaction to: Chondroitin sulfate, Maltodextrin, Mannitol, Magnesium Stearate, Silicon dioxide, Microcrystalline cellulose, or Talc.
  • Known sensitivity or intolerance to wheat or gluten.
  • General Compliance
  • - 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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Interventions

DIETARY_SUPPLEMENTMyCondro 300mg

This is a non-animal Chondroitin sulfate formulation.

DIETARY_SUPPLEMENTMyCondro 600mg

This is a non-animal Chondroitin sulfate formulation.

Locations(1)

People Science

Los Angeles, California, United States

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NCT07493239