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临床试验/NCT06080347
NCT06080347招募中不适用

An Evaluator-blinded Randomized Controlled Trial Study of the Effect of Anti-inflammatory Diet in Subjects With Osteoarthritis

University of California, San Diego2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年10月1日最近更新:
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适应症

试验速览

阶段
不适用
状态
招募中
入组人数
72
试验地点
2
主要终点
Change in Knee Osteoarthritis Pain
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

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 Osteoarthritis, 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
Double (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

  • •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

排除标准

  • •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

结局指标

主要结局

Change in Knee Osteoarthritis Pain

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Monica Guma

Associate Professor

University of California, San Diego

研究点 (2)

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Effect of Anti-inflammatory Diet in Osteoarthritis | 临床试验