A MyCondro™ két különböző adagjának fizikai mobilitásra és ízületi egészségre gyakorolt hatékonyságát értékelő decentralizált klinikai vizsgálat
Egy véletlenszerű, kettős vak vizsgálat, amely a MyCondroTM két különböző adagjának hatékonyságát értékeli fizikai mobilitás és ízegészség szempontjából, résztvevők által jelentett eredmények felhasználásával, azoknál az egyéneknél, akiknél a térdosteoarthritishez kapcsolódó, önként jelentett mobilitási problémák fordulnak elő.
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.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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California
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Los Angeles, California, Egyesült Államok, 90045
- People Science
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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 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 Criteria:
Any potential participants will be excluded if they meet any of the following criteria:
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Technology Limitation: Do not have a personal smartphone, lack internet access, or are unwilling to download the Chloe app.
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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
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Támogató gondoskodás
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Hármas
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: 300 mg
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 |
This is a non-animal Chondroitin sulfate formulation. |
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Kísérleti: 600 mg
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 |
This is a non-animal Chondroitin sulfate formulation. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
MyCondro's effectiveness
Időkeret: 12 weeks
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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
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Knee Symptoms and Physical Function
Időkeret: 14 weeks
|
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. |
14 weeks
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Knee pain at rest and in motion
Időkeret: 14 Weeks
|
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
|
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Subjective Impression of Improvement
Időkeret: 14 weeks
|
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
|
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Overall Quality of Life
Időkeret: 14 weeks
|
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
|
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Systemic Inflammatory Blood Markers
Időkeret: 14 weeks
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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
|
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Reliance on Rescue Medications
Időkeret: 14 weeks
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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
|
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Safety and Tolerability
Időkeret: 14 weeks
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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
|
Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Physical Activity via wearable device
Időkeret: 14 weeks
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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. |
14 weeks
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Participant Experience and Study Design Feedback
Időkeret: 14 weeks
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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
|
Együttműködők és nyomozók
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: Noah Craft, MD, PhD, People Science, Inc.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- PS24
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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