NCT05282992已完成不适用
A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Tolerability of a Food Supplement in Healthy Volunteers With Joint Discomfort
Bioiberica1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2022年3月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in joint discomfort onset
研究概览
简要总结
Collagen Supplement is a natural ingredient that contains native collagen derived from chicken sternum. Collagen Supplement is efficacious and safe on healthy subjects as compared to placebo.
详细描述
This study will include 100 healthy volunteers in which will be evaluated if the collagen supplement is able to obtain differences versus placebo in pain and function. It will be a randomized, double-blind, placebo-controlled study with proportion 1:1 between treatments
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 是
入选标准
- •Males and non-pregnant females 30-65 years old with a Body Mass Index (BMI) of approximately 18 to 30 kg/m
- •(see Section 4.0)
- •Unilateral or bilateral knee discomfort for greater than 3 months.
- •VAS score during knee movement between 30-50 mm after 7-day withdrawal of excluded medications.
- •Reach joint discomfort of 5/10 on a 11-point Likert scale ( score 0 to 10) within 10 minutes of going up and down stairs.
- •Clinical laboratory results that are within normal range or considered not clinically significant by the Principal Investigator.
- •Be willing to participate in all scheduled visits, tests, and other trial procedures according to the clinical protocol. To do so and be able of using the fitness tracker, a phone or tablet compatible with the Fitbit app is required. (Apple iOS 12.2 or higher, Android OS 7.0 or higher.)
- •Be willing to refrain from taking ibuprofen, aspirin or other Non-steroidal anti-inflammatory drugs (NSAIDs), or any other pain reliever (OTC (Over the Counter) or prescription) during the entire study other than acetaminophen (paracetamol) as rescue medication.
- •Provide a signed and dated informed consent indicating that the subject has been informed of all pertinent aspects and possible risks associated with participation in the study.
- •Be willing to refrain from taking dietary supplements during the entire study that have any underlying joint benefit (collagen, glucosamine, chondroitin, MSM, Hyaluronic Acid, Turmeric, Natural Eggshell Membrane, Omega-3 fatty acids, PEA, Boswellia,…)
排除标准
- •History of hypersensitivity to the rescue medication or any of the products used in the study.
- •Requirement of drugs to control joint discomfort.
- •Regular drug intake to control any kind of pain.
- •History of hypersensitivity to eggs, chicken, or fowl.
- •History of Knee OA (OsteoArthritis), inflammatory arthropathy, RA (Rheumatoid Arthritis), OA (VAS score greater than 50), or Systemic Lupus Erythematosus.
- •Hyperuricemia (>440 μmol/L), history of gout, or both.
- •Exercising (intentionally) for more than 10 hours a week
- •High intensity exercise for more than 5 hours a week
- •Anticipation of surgery within the next 6 months.
- •Recent injury in the target knee (past 4 months).
- •History of congestive heart failure.
- •Anticipated problems with product consumption.
- •Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies within the last 5 years.
- •High alcohol intake (>2 standard drinks per day) or use of recreational drugs (e.g., cocaine, methamphetamine, marijuana, etc.).
- •Females who are pregnant or lactating or planning to become pregnant.
- •History of any mental illness that might impair the ability of subjects to provide a written informed consent.
- •Use of oral corticosteroid, indomethacin, SYSADOAs (symptomatic slow action drug osteoarthritis) within 3 months of Visit 1; topical treatment with corticosteroids within 1 week of visit 1, and consumption of Omega 3 fatty acids or any other joint health dietary supplements within 2 weeks preceding the treatment period.
- •Consumed, ibuprofen, aspirin or other NSAIDS, or any other pain reliever (OTC or prescription), or any natural health product, (excluding vitamins) within 7 days of first visit.
- •Consumed acetaminophen (paracetamol) within 48 hours of randomization visit.
- •Participation in any clinical trials within 30 days prior to first visit.
- •Individuals following an energy restricted diet for weight loss
结局指标
主要结局
Change in joint discomfort onset
时间窗: Change in joint discomfort onset at 6 months
Determine differences from baseline on reaching a joint pain of 5/1 while going up and down stairs (max 10 min).
次要结局
- Joint function(Day 0 to day 60, 90, 120, 180)
- 6 minute walking timed test (6MWT)(Day 0 and 180)
- Cartilage turnover biomarkers(Day 0 and 180)
- Time to Joint discomfort(Day 0 to day 60, 90, 120, 180)
- Rescue medication consumption(Day 0 to 180, anytime)
- Joint discomfort(Day 0 to day 60, 90, 120, 180)
研究者
研究点 (1)
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