Effect of Prebiotics on Function and Pain in Patients with Knee Osteoarthritis and Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Change in 30 second chair stand test
研究概览
简要总结
The purpose of the present study is to determine if prebiotic supplementation can, through changes in the intestinal gut microbiota, lead to improvements in knee function and physical performance and reduce knee pain in adults with obesity and idiopathic metabolic knee osteoarthritis. We hypothesize that prebiotics will reduce systemic and local (knee joint) inflammation, thus improving knee function, lower pain medication use, and enhance performance of daily life activities.
详细描述
Primary outcome:
- To determine the change in knee joint function and physical performance in adults with obesity and knee osteoarthritis treated for 6 months with oligofructose-enriched inulin or placebo.
Secondary outcomes:
- To determine the change in knee pain in adults with obesity and knee osteoarthritis treated for 6 months with oligofructose-enriched inulin or placebo.
- To examine the change in body composition (fat mass and lean mass) in participants treated with oligofructose-enriched inulin or placebo.
- To evaluate the change in quality of life in participants treated with oligofructose-enriched inulin or placebo.
- To gain a mechanistic understanding of the influence of oligofructose-enriched inulin supplementation in metabolic OA through examination of gut microbiota composition and short-chain fatty acid concentrations.
- To gain a mechanistic understanding of the influence of oligofructose-enriched inulin supplementation in metabolic OA through examination of serum inflammatory and metabolomics markers.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adults aged 30-75 years of age.
- •BMI greater than 30kg/m
- •Diagnosis via x-ray of knee OA grade II and III (Kellgren and Lawrence).
排除标准
- •Knee OA resulting from a traumatic injury.
- •Previous knee surgery.
- •Concomitant use of any weight loss medication, previous bariatric or other intestinal surgery
- •Presence of active infection, pregnancy or lactation.
- •Regular use of a probiotic or prebiotic supplement within 3 months prior to enrollment.
- •Antibiotic use within 3 months prior to enrollment
- •Uncontrolled cardiovascular or respiratory disease, active malignancy, or chronic infections.
结局指标
主要结局
Change in 30 second chair stand test
时间窗: Baseline and 6 months
30 second chair stand test
Change in knee function
时间窗: Baseline and 6 months
Knee extensor torque isokinetic dynamometer (Biodex System3)
Change in 40 metre fast based walk
时间窗: Baseline and 6 months
40 metre fast based walk
Change in Time up and go test
时间窗: Baseline and 6 months
Time up and go test
Change in 6 minute walk test
时间窗: Baseline and 6 months
6 minute walk test
次要结局
- Change in serum metabolomics(Baseline and 6 months)
- Change in body fat(Baseline and 6 months)
- Change in knee pain(Baseline and 6 months)
- Change in serum inflammatory marker(Baseline and 6 months)
- Change in physical activity level(Baseline and 6 months)
- Change in fecal short chain fatty acids (SCFA) concentration(Baseline and 6 months)
- Change in knee injury and osteoarthritis outcome score (KOOS)(Baseline and 6 months)
- Change in pain medication use(Baseline and 6 months)
- Change in fecal microbiota composition(Baseline and 6 months)
- Change in serum endotoxin(Baseline and 6 months)
- Change in quality of life ratings(Baseline and 6 months)
研究者
Dr. Raylene Reimer
Professor
University of Calgary