NCT03072108已完成不适用
Effect of Oleuropein-based Dietary Supplement (Bonolive™) Versus Placebo on Knee Joint Functionality and Cartilage Catabolism in Ageing Population
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2016年6月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Evaluation of the effect of investigational product after 6 months of supplementation
研究概览
简要总结
This clinical study evaluates if the oral administration of Bonolive can contribute to the improvement of functionnality in healthy elderly people with knee discomfort.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female ≥ 55 years of age
- •BMI between 18.5 and 29.9 kg/m2 (normo and overweight)
- •Moderate knee pain (the most painful knee is considered)
- •Able to follow the instructions of the study
- •Able to perform physical tests
- •Having signed an informed consent
排除标准
- •Related to knee
- •Recent trauma (< 1 month) of the knee responsible of the symptomatic knee
- •Subject with knee/joint surgery/replacement and ACL (Cross Ligament) injury in the target knee
- •Concurrent articular disease interfering with the evaluation of pain such as articular dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, hemophilia, hemochromatosis, chondromatosis, villonodular synovitis of the knee, seronegative spondyloarthropathy, rheumatoid arthritis, gouty arthritis , infectious arthritis, radiculalgia in the lower limbs, arteritis
- •Prosthesis in the target knee
- •Diagnosed arthrosis eligible to knee/joint surgery/replacement
- •Related to treatments
- •Analgesics to manage knee pain 24h before inclusion visit
- •Corticosteroids injection in the target knee in the month preceding inclusion
- •Hyaluronan injection in the target knee in the last 6 months
- •Oral corticotherapy ≥ 5mg/day in the last 3 months
- •Symptomatic slow-acting drugs (SYSADs) treatment (Chondroitin, diacerein, glucosamine, soy and avocado unsaponifiables) in the last 3 months
- •Other dietary supplements used for articular disorders in the last 3 months
- •An anticipated need for the duration of the trial of corticosteroids or hyaluronan injection, oral corticotherapy, arthroscopy, analgesics other than listed as rescue treatments, which are forbidden during the trial
- •Arthroscopy in the last 6 months
- •Allergy or contra-indication to Oleuropein, to maltodextrin or any ingredient present in the product, or intolerance to rescue treatment (Paracetamol and NSAIDs)
- •Treatments based on strontium ranelate, bisphosphonates, selective estrogen-receptor modulator (SERM) and parathormone (PTH) during the year before inclusion
- •Related to associated diseases
- •Severe and uncontrolled diseases (liver or renal failure, lung/heart severe disease, Parkinson, progressive malignant neoplasia or in remission for less than 5 years, HIV, etc.)
- •Lower or upper extremity surgery or fracture in the last 3 months
- •Anticipated need for any surgical or other invasive procedure during the trial including prosthesis in the target knee
- •Swallowing disorder
- •Related to patients
- •Close collaborators to the investigational team, the study coordinator (Artialis) or to the Sponsor (Nestlé)
- •Currently participating or having participated in another therapeutic clinical trial in the three previous months
- •Having made a blood donation in the past month
- •Under guardianship or judicial protection
- •Pregnancy, breastfeeding, planned conception
- •Premenopausal women or women without tubal ligation or contraception.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
Bonolive
Experimental
干预措施: Bonolive (Dietary Supplement)
结局指标
主要结局
Evaluation of the effect of investigational product after 6 months of supplementation
时间窗: From Baseline to 6 months of product administration and compared to Placebo
KOOS (Knee injury and Osteoarthritis Outcome Score)
次要结局
- Evaluation of the effect of investigational product(From Baseline to 6 months of product administration and compared to Placebo)
研究者
研究点 (2)
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