抗炎饮食对骨关节炎的影响
评估者盲法随机对照试验研究抗炎饮食对骨关节炎患者的影响
In a previous exploratory study, the investigators observed an effect on disease activity outcomes of anti-inflammatory diet. The investigators also observed change in microbiome and circulating metabolites. The current study will determine whether or not the addition of anti-inflammatory diet improves the clinical outcomes in participants with Osteoarthritis, and the role of microbiome and circulating metabolites.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Monica Guma, M.D., PhD
- 电话号码：8588226523
- 邮箱：mguma@health.ucsd.edu
学习地点
-
-
California
-
San Diego、California、美国、92122
- 招聘中
- University of California
-
接触：
- Monica Guma, M.D, PHD
- 邮箱：mguma@health.ucsd.edu
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Unilateral radiographic symptomatic KOA
- No changes in therapy during the previous 3 months
- Interested in dietary intervention and able to provide consent and attend follow-up visits
Exclusion Criteria:
- Previous knee surgery
- Severe radiographic disease (KL grade 4)
- Rheumatoid Arthritis
- Any Abnormal blood values in the comprehensive metabolic panel test at screen (Abnormality will be defined based on standard reference ranges)
- Use of corticosteroids and/or intra-articular injections during the preceding 3 months
- Use of fish oils and glucosamine
- Participation in a weight loss program in the preceding 6 months
- Recent changes in physical activity levels
- Regular smoking
- Patients with food allergies
- Patient with other medical conditions that will impair the ability to participate in a nutritional study
- Plan to change systemic therapy
- Patients unwilling to change dietary habits
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Arm_1
Anti-inflammatory Diet |
Dietary intervention |
|
实验性的：Arm_2
Healthy Diet |
Dietary intervention |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Knee Osteoarthritis Pain
大体时间：3 months
|
The Western Ontario and McMaster Universities Osteoarthritis Index, known as the WOMAC score, is a validated questionnaire used for evaluating pain, stiffness, and physical function in individuals with knee or hip osteoarthritis. A minimum score of 0 indicates no symptoms and a maximum score of 100, represents the most severe symptoms. Higher WOMAC scores correspond to worse outcomes, indicating more significant pain, stiffness, and functional limitations associated with osteoarthritis. The primary outcome for the purpose of this study will be the proportion of patients experiencing a change of at least 30% in WOMAC-pain score after 3 months of intervention compared to the control group. |
3 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.