The Effect of Phenolic Cmpounds in Osteoarthritis; a Nutritional Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- WOMAC™ Osteoarthritis Index Pain Subscale
研究概览
简要总结
The main objective of the study is to elucidate the beneficial effect of a dietary supplement with phenolic compounds in patients with OA versus ascorbic acid.
The analysis of the data is expected to clarify the role of the new supplement as one with a positive effect on OA-related biomarkers, on functional abilities and on the quality of life of patients with OA.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •symptomatic knee OA (patients with at least moderate symptoms)
- •patients should be able to walk without a medical or other support device (such as a walking stick, crutches, or a kneecap).
排除标准
- •Patients undergoing physical therapy or TENS, have rheumatoid arthritis, fibromyalgia, spinal disorders or any other disorders that according to the physician is a bias, stiffness> 30 minutes, have scheduled knee surgery or any other programmed surgery during the trial, show WOMAC pain scale <4 for pain overall, those with a diagnosis of kidney or liver disease, coagulation disorders, any form of cancer, HIV infection, type I diabetes, those with unregulated type II diabetes, those using illicit substances or having a history of substance or alcohol abuse over the past 2 years (or those who consume more than 2 typical alcoholic beverages / day in the present), those using corticosteroids within 2 months prior to randomization and during the trial, those who change their diet or supplementation 1 month or during the recruitment/trial, those using ascorbic acid supplement or any phytochemical-rich supplement, women on estrogen replacement therapy, during pregnancy or lactation and those judged by the researcher as unable to perceive and comply with the obligations laid down in the Protocol and for which consent and voluntary participation is sought.
研究组 & 干预措施
ascorbic acid / phytochemical supplement
A mixture of active phenolic compounds with ascorbic acid
干预措施: Ascorbic acid / phytochemical supplement (Dietary Supplement)
ascorbic acid
Ascorbic acid group
干预措施: Ascorbic acid (Dietary Supplement)
结局指标
主要结局
WOMAC™ Osteoarthritis Index Pain Subscale
时间窗: 3 months
It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: * Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright * Stiffness (2 items): after first waking and later in the day * Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Visual Analogue Scale - VAS
时间窗: 3 months
The Visual Analogue Scale - VAS is a unidimensional measure of pain intensity. It is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.
次要结局
- WOMAC™ Osteoarthritis Index Stiffness Score(3 months)
- WOMAC™ Osteoarthritis Index Physical Function Score(3 months)
- Questionnaire SF-36(3 months)
- Circulating Inflammatory markers(3 months)
- Circulating oxidative damage markers(3 months)
- Circulating miRNAs(3 months)
研究者
Andriana C Kaliora
Assistant Professor in Foods and Human Nutrition
Harokopio University