Effects of Freeze-dried Strawberries on Systemic Markers of Inflammation and Knee Function in Participants With Osteoarthritis (OA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Pain Scores on the Visual Analog Scale
研究概览
简要总结
The proposed study aims to examine the hypothesis that strawberry supplementation will lower serum biomarkers of inflammation and improve knee function in patients with symptomatic osteoarthritis (OA).
详细描述
The investigators propose the following two specific aims in a randomized crossover placebo-controlled trial in participants with two or more features of the metabolic syndrome and symptomatic osteoarthritis in this 12-week efficacy study:
Aim 1: To assess the effects of strawberries on biomarkers of inflammation [serum levels of C-reactive protein: CRP; inflammatory cytokines: interleukin-6: IL-6; interleukin 1β: IL-1β; tumor necrosis factor-alpha: TNFα] Aim 2: To assess the effects of strawberries on knee function as assessed by overall musculoskeletal examination and pain score (ICOAP, KOOS and HAQ-DI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of knee osteoarthritis
- •Must have waist circumference >35 inches for women and >40 inches for men
排除标准
- •Heart disease
- •Berry allergy
研究组 & 干预措施
FDS-Strawberry
Freeze-dried strawberry powder (50g/d)
干预措施: FDS-Strawberry (Dietary Supplement)
Placebo
Powder matched for carbohydrates and fiber in the strawberries
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Pain Scores on the Visual Analog Scale
时间窗: six months
Inflammatory Biomarkers in Serum
时间窗: six months
次要结局
未报告次要终点
研究者
Arpita Basu
Associate Professor
Oklahoma State University