Anti-inflammatory Effect of Serum of Osteoarthritis Patients After Administration of the Oléogrape®SEED, an Extract of Grape and Olive
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- biochemical assays of PGE2 production in the cell culture supernatant to measure the anti-inflammatory action of patients' sera
研究概览
简要总结
Osteoarthritis is a degenerative disease that affects a growing proportion of the population. There is currently no treatment to halt this process. The aim of the research is in particular to find treatments targeting the molecular origins of osteoarthritis focusing especially on the inflammatory component of the disease. That is why research is looking to the development of preventive treatments like nutraceuticals. This project aims to determine the anti-inflammatory properties of sera of patients who received supplementation of their diet with an extract of grape and olive: the Oléogrape®SEED. Sera and synovial fluid will be collected during visits for hyaluronic acid injections in OA patients. These sera will be tested in vitro in a model of inflamed chondrocytes.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50 years old and over
- •Patients with knee osteoarthritis (ACR criteria)
- •Patients requiring injection of hyaluronic acid (no corticosteroid associated)
- •Radiological stage of knee osteoarthritis 1, 2 or 3 (Kellgren-Lawrence)
- •Informed consent form signed
排除标准
- •younger than 50 years
- •protected adult
- •Pregnant woman
- •Radiological Stage 4 osteoarthritis (Kellgren-Lawrence)
- •knee osteoarthritis secondary to arthritis
- •Taking a long term treatment of osteoarthritis (Piasclédine®, Diacéréine®, glucosamine, chondroitin)
- •inflammatory pathology other than osteoarthritis
- •Taking anti-inflammatory medications
- •Refusal to participate in the study
- •Use of food supplements with anti-inflammatory properties
- •Arthroscopy less than 6 months
- •corticosteroid injection <3 months
- •INR> 4 or TCA> 2 (anticoagulants)
- •Being allergic to lactose
研究组 & 干预措施
Placebo
Patients are taking capsules of placebo (lactose) 3 times a day in the morning, at noon and in the evening during 7 days
干预措施: Lactose (Drug)
Oleogrape
Patients are taking capsules of OleograpeSEED (Extract of grape and olive) 3 times a day (1mg/day) in the morning, at noon and in the evening during 7 days
干预措施: Extract of grape and olive (Drug)
结局指标
主要结局
biochemical assays of PGE2 production in the cell culture supernatant to measure the anti-inflammatory action of patients' sera
时间窗: 7 days
biochemical assays of NO production in the cell culture supernatant to measure the anti-inflammatory action of patients' sera
时间窗: 7 days
次要结局
- qualitative evaluation by mass spectrometry to assess the bioavailability of polyphenols in the patients' sera(7 days)