Joint HealthNCT07493239
A Decentralized Clinical Study Evaluating the Effectiveness of Two Different Doses of MyCondro™ on Physical Mobility and Joint Health
A study testing MyCondro 300mg and MyCondro 600mg in people with Joint Health, run by Lesaffre International at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Joint Health
- What is being tested?
- MyCondro 300mg and MyCondro 600mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2026to 28 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Being tested
- MyCondro 300mg, MyCondro 600mg
- Keywords
- MyCondro, Gnosis, PS24, Joint function, Joint mobility, non-animal chondroitin sulfate
- Medical subject headings
- Noonan syndrome 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyCondro 300mgDietary supplement
This is a non-animal Chondroitin sulfate formulation.
MyCondro 600mgDietary supplement
This is a non-animal Chondroitin sulfate formulation.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: MyCondro 300mg |
| 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 Receives: Dietary Supplement: MyCondro 600mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start4 Mar 2026
- Primary completion28 Aug 2026
- Study completion28 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lesaffre International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Responsible party
- Sponsor
- Investigators
- Noah Craft, MD, PhD, Principal investigator, People Science, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493239
- Sponsor's protocol ID
- PS24
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07493239
- Acronym / sponsor ID
- PS24
- Conditions
- Joint Health
- Keywords
- MyCondro, Gnosis, PS24, Joint function, Joint mobility, non-animal chondroitin sulfate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Lesaffre InternationalIndustry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- 28 Aug 2026 (actual)
- Study completion
- 28 Aug 2026 (actual)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 300 mg | Experimental | Dietary Supplement: MyCondro 300mgParticipants 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 |
| 600 mg | Experimental | Dietary Supplement: MyCondro 600mgParticipants 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 |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (20 listed)
- 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
- Self-reported inflammatory arthropathies, such as Rheumatoid Arthritis, Gout, and Infectious Arthritis.
- Significant systemic lung, liver, heart, or kidney disease (excluding hypertension).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyCondro 300mgThis is a non-animal Chondroitin sulfate formulation. | Dietary supplement | 300 mg |
| MyCondro 600mgThis is a non-animal Chondroitin sulfate formulation. | Dietary supplement | 600 mg |
Primary outcome
MyCondro's effectiveness
Time frame: 12 weeks
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
7 secondary outcomes
Knee Symptoms and Physical Function
Time frame: 14 weeks
Knee pain at rest and in motion
Time frame: 14 Weeks
Subjective Impression of Improvement
Time frame: 14 weeks
Overall Quality of Life
Time frame: 14 weeks
Systemic Inflammatory Blood Markers
Time frame: 14 weeks
Reliance on Rescue Medications
Time frame: 14 weeks
Safety and Tolerability
Time frame: 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noah Craft, MD, PhD principal investigator
People Science, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyCondro 300mg and MyCondro 600mg in people with Joint Health, run by Lesaffre International at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MyCondro's effectiveness (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.