Randomized, Double-blind, Controlled Nutritional Intervention Study of Parallel Groups to Evaluate the Effect of Consuming a Bioactive Compound (EPP) on Joint Health in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- KOOS test total score.
研究概览
简要总结
The objective of this trial is to determine the efficacy of oral administration of a bioactive compound (EPP) in healthy individuals with mild knee joint discomfort.
详细描述
It is estimated that the incidence of osteoarthritis (OA) is increasing exponentially worldwide, with serious consequences, not only on the quality of life and functionality of the subjects, but also a high burden on the social and health care systems of the countries. Existing treatments for OA are either invasive, and therefore risky for the subject and high cost, or have side effects and cannot be maintained over time. Therefore, there is a high demand to find effective and safe therapies to prevent and/or treat OA, such as functional ingredients or compounds present in food. In this regard, our experimental bioactive compound has been developed and shown to be safe and effective in reducing joint pain and improving quality of life in a previous study.
The aim of this study is to evaluate the effect of the consumption of our bioactive compound, in healthy Spanish individuals with mild joint discomfort in the knee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants (men and women) between 35 and 65 years of age with knee discomfort.
- •Mild knee joint pain (visual analog scale between 3 and 6 cm).
排除标准
- •People with clinical osteoarthritis or any other degenerative joint disease.
- •Persons receiving treatment with anti-inflammatory or chondroprotective drugs (chondroitin sulfate, glucosamine, HA, diacerein) two weeks prior to screening.
- •Persons receiving intra-articular injections in the knee joint in the 3 months prior to the study.
结局指标
主要结局
KOOS test total score.
时间窗: 12 weeks
Using of the KOOS (Knee Injury \& Osteoarthritis Outcomes) Questionnaire.
次要结局
- KOOS Subscales score (pain, symptoms, daily activity, sport and quality of life).(12 weeks)
- VPS scale for knee pain (general and after physical tests performed at the visits).(12 weeks)
- Objective assessment of physical activity.(12 weeks)
- Range of motion of the knee joint.(12 weeks)
- Changes observed between baseline and final MRI.(12 weeks)
- Lower body strength and power.(12 weeks)