NCT04748809招募中不适用
An Evaluator-blinded Randomized Controlled Trial Study of the Effect of Anti-inflammatory Diet in Subjects With Rheumatoid Arthritis.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Decrease of more than 5 points in Clinical Disease Activity Index
研究概览
简要总结
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 rheumatoid arthritis, and the role of microbiome and circulating metabolites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, 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
- •Patients with low or moderate disease activity (defined as Clinical Disease Activity Index ≤ 22) and without changes in disease activity or therapy during the previous 3 months, who are interested in dietary intervention, and are able to provide consent and attend to follow up visits.
排除标准
- •Pregnancy or lactating. Patients that will become pregnant during the study will be remove from the study.
- •Food allergies
- •Subjects with significant other comorbidities and /or medication use which in physician's clinical judgment might difficult the interpretation of the results
研究组 & 干预措施
Arm_1
Active Comparator
Anti-inflammatory diet 1
干预措施: Diet 1 (Other)
Arm_2
Experimental
Anti-Inflammatory diet 2
干预措施: Diet 2 (Other)
结局指标
主要结局
Decrease of more than 5 points in Clinical Disease Activity Index
时间窗: 3 months
次要结局
未报告次要终点
研究者
Monica Guma
Associate Professor of Medicine
University of California, San Diego
研究点 (1)
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