Efficacy of Hydrolyzed Collagen as a Food Supplement in the Reduction of Osteoarticular Pain and Functional Limitation: Results From a Randomized, Double-blind, Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in baseline functional limitation at 6 months
研究概览
简要总结
This randomised study evaluates the efficacy of an oral dietary supplement of Hydrolyzed Collagen in reducing pain and improving physical function in subjects with osteoarthritis.
详细描述
In recent years, research efforts have focused on interventions such as collagen supplementation as an alternative treatment for pain and physical function in patients with osteoarthritis. Hydrolyzed collagen (HC) is a mixture of collagen peptides with a molecular weight of less than 5,000 Da. It is obtained from the gelatinization and subsequent enzymatic hydrolysis of native collagen from animal tissues rich in this protein. In this line, several studies show that HC is more easily absorbed enzymatically, has a higher bioavailability, is distributed to joint tissues, and has analgesic and anti-inflammatory properties, consistently showing symptom-relieving effects, thus improving joint function and reducing joint pain, as well as optimizing the patient's quality of life. In this randomized pilot study, the investigators aimed to evaluate the effect on pain and other parameters related to physical function of an oral dietary HC supplement composed of lemon flavoring, anhydrous citric acid (acidifier), calcium ascorbate (vitamin C), sucralose (sweetener) and stevia (sweetener). A 10.728 g dose provides 10 g of HC and 80 mg of vitamin C. Each placebo packet contained sucralose (sweetener) and stevia (sweetener) in identical proportions to the active preparation. Both the active and the placebo were manufactured by NutraResearch© SL (Barcelona, Spain) under Good Manufacturing Practices (GMPs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of osteoarthritis according to the clinical and radiographic criteria of the American College of Rheumatology.
- •Pain score of at a minimum of 50 mm on a VAS scale of 0-100 mm
排除标准
- •Presence of a previous cardiovascular event in the last 6 months.
- •History of liver or kidney disease.
- •Presence of medical condition requiring chronic treatment with drugs or other substances.
- •Excessive alcohol consumption (> 20 g/day) or substance abuse.
- •Presence of intolerance or hypersensitivity to the food supplement or to any of its components in isolation.
- •Use of any intra-articular injection in the anatomical area under study in the last 6 months.
- •Treatment with symptomatic slow-acting osteoarthritis drugs (SYSADOA) in the last 3 months.
- •Criteria listed in the Clinical Investigation Guideline for medicinal products used in the treatment of osteoarthritis published by the European Medicines Agency of the European Union in 2010 and radiographic osteoarthritis grade 4 according to the Kellgren-Lawrence classification system.
- •Any condition that, in the opinion of the investigators, would disqualify the subject from participation in the study.
结局指标
主要结局
Change in baseline functional limitation at 6 months
时间窗: 0 and 6 months
Functional limitation, assessed by Lesquene Algofunctional Index through a repeated measures analysis at two time points (baseline and end of intervention)
Change in baseline osteoarticular pain at 6 months
时间窗: 0 and 6 months
Pain level, assessed by Visual Analogue Scale through a repeated measures analysis at two time points (baseline and end of intervention).
次要结局
- Change in C-reactive protein (CRP)(0 and 6 months)
- Patient satisfaction with treatment(6 months)
- Treatment-emergent adverse effects(6 months)
- Change in erythrocyte sedimentation rate (ESR)(0 and 6 months)
研究者
Francisco Jose Rodriguez Velasco
Professor
Universidad de Extremadura
