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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- MyCondro's effectiveness
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
- •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.
结局指标
主要结局
MyCondro's effectiveness
时间窗: 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
次要结局
- Knee Symptoms and Physical Function(14 weeks)
- Knee pain at rest and in motion(14 Weeks)
- Subjective Impression of Improvement(14 weeks)
- Overall Quality of Life(14 weeks)
- Systemic Inflammatory Blood Markers(14 weeks)
- Reliance on Rescue Medications(14 weeks)
- Safety and Tolerability(14 weeks)