Effect of Chondractiv Move (Dietary Supplement) on Activity-related Joint Discomfort in Physically Active Subjects: a Double-blind, Randomized, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Change from baseline of activity-related joint discomfort at 8 weeks
研究概览
简要总结
Joint discomfort, manifested as knee pain or gonalgia, is a common problem not only among athletes, but also among people who regularly take part in physical activities and sports. This discomfort can limit mobility and flexibility, even in healthy people who do not suffer from osteoarthritis or other joint diseases. Functional joint discomfort is also due to joint stress and the short-term deterioration of cartilage. The processes of cartilage formation and degradation lose their balance under load, and discomfort is felt for some time after exercise. These conditions and symptoms occur long before the onset of a disease such as osteoarthritis.
Dietary supplements based on herbs or collagen derivatives (a protein involved in maintaining the structure of tissues, including those of the joints) are frequently used to alleviate the discomfort associated with joint disorders and improve the balance between cartilage synthesis and degradation.
This study aims to assess the effect of the dietary supplement "Chondractiv Move" (named "Chondractiv Boost" at the time of protocol writing) on joint discomfort induced by physical activity. This is a combination of rosehip extract and hydrolyzed chicken cartilage containing collagen type II, chondroitin sulfate, and hyaluronic acid as main actives. This combination is chosen based on the results of studies showing the beneficial effects on joints of the ingredients.
详细描述
This study requires the inclusion of about 140 participants who regularly take part in sporting activities and report knee pain during and/or after this activity.
Participants are randomly assigned to the control group receiving a placebo (a neutral product based on maltodextrins with no effect), or to the test group receiving the dietary supplement. This study is a double-blind, randomized controlled trial. This means that participants as well as assessors do not know the allocation group. This is a necessary procedure to guarantee impartiality in clinical trials.
Participants ingest placebo or dietary supplement for 8 consecutive weeks (or 12 weeks in the ancillary group with extended supplementation duration).
To assess the effect of supplementation, participants are asked to attend medical check-ups and complete questionnaires, before starting the treatment to determine basal values, and then at regular intervals, i.e. every 2 weeks or every month.
Throughout their participation, participants are monitored by the study doctor and must go to a clinical investigation center for doctors visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index ≥ 18.5 and < 30.0 kg/m
- •Physically active: joint bearing sports (i.e., but not limited to soccer, basketball, handball, volleyball, tennis, running) for at least 3 hours per week or 2 times per week.
- •Who self-report activity-related discomfort or reversible knee-joint discomfort during or immediately after physical activity over a period of at least 2 months.
- •Who experience pain intensity of 5 (out of 10 on the 11 point-NRS) during the stress joint test (SLSD) and perform at least 25 repetitions.
- •Who have no trouble swallowing capsules
- •Having a smartphone allowing using the e-PRO App NursTrial®.
- •Affiliated to a French Health insurance scheme.
- •Signed informed consent.
排除标准
- •With diagnosed injury/trauma or tendinopathy (wiper syndrome, patellofemoral syndrome, meniscopathy), algodystrophy, osteoarthritis, rheumatic arthritis or inflammation, or other knee or joint disease.
- •Extreme pain symptoms that required high-dose analgesic therapy over a longer period (>2 weeks) or intra-articular injection treatment.
- •Untreated or unstable hypothyroidism, or evidence of any neurological disorders.
- •Known hypersensitivity to one of the components of the experimental products (i.e., dog rose).
- •Intra-articular injections or infiltrations with hyaluronic acid, plasma-rich platelet, glucosamine, chondroitin, or supplementation, with glucosamine, chondroitin, collagen-based products in the last 3 months, or spa therapy related to join health in the last 6 months.
- •Current intake of corrective treatment, plant-based products or dietary supplements that could interfere with joint, tendon or bone metabolism.
- •May not be compliant or may not respect the constraints imposed by the protocol (i.e., stable physical activities and dietary habits throughout the study).
- •Enrolled in another clinical trial or being in a period of exclusion from a previous clinical trial.
- •For woman of childbearing age (neither menopausal, nor hysterectomised, nor sterilized): not using effective contraception (oral contraceptives, intra-uterine device, contraceptive implant, or condoms).
- •Belonging to a population covered by articles L.1121-5 (pregnant confirmed by urinary test at inclusion or breastfeeding women), L.1121-6 (persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care), and L.1121.8 (adults under legal protection or unable to express their consent) of the CSP (French Public Health Code).
结局指标
主要结局
Change from baseline of activity-related joint discomfort at 8 weeks
时间窗: Baseline (Day 0), 8 weeks (Day 56)
The pain-related activity is assessed by 0-10 Visual Analogic Scale (VAS) during SLSD (Single-Leg-Step-Down) test.
次要结局
- Change from baseline of activity-related joint discomfort at 4 weeks.(Baseline (Day 0), 4 weeks (Day 28))
- Change from baseline of activity-related joint discomfort at 12 weeks(Baseline (Day 0), 4 weeks (Day 84))
- Activity-related pain at regular exercise/physical activity(Baseline (Day 0), 4 weeks (Day 84))
- Change from baseline on overall physical function at 2 weeks(Baseline (Day 0), 2 weeks (Day 14))
- Change from baseline on overall physical function at 4 weeks(Baseline (Day 0), 4 weeks (Day 28))
- Change from baseline on overall physical function at 6 weeks(Baseline (Day 0), 6 weeks (Day 42))
- Change from baseline on overall physical function at 8 weeks(Baseline (Day 0), 8 weeks (Day 56))
- Change from baseline on overall physical function at 10 weeks(Baseline (Day 0), 10 weeks (Day 70))
- Change from baseline on overall physical function at 12 weeks(Baseline (Day 0), 12 weeks (Day 84))
- Change from baseline of knee mobility at 4 weeks(Baseline (Day 0), 4 weeks (Day 28))
- Change from baseline of knee mobility at 8 weeks(Baseline (Day 0), 8 weeks (D56))
- Change from baseline of knee mobility at 12 weeks(Baseline (Day 0), 12 weeks (Day 84))
- Change from baseline of quality of life at 4 weeks(Baseline (Day 0), 4 weeks (Day 28))
- Change from baseline of quality of life at 8 weeks(Baseline (Day 0), 8 weeks (Day 56))
- Change from baseline of quality of life at 12 weeks(Baseline (Day 0), 12 weeks (Day 84))
- Satisfaction with the supplementation(8 weeks (Day 56) or 12 weeks (D84) for ancillary group)