PLATE: Health Effects of Plant-Based Diet in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Disease activity measured by DAS28
研究概览
简要总结
The goal of this clinical trial is to evaluate the effect of a plant-based diet (PBD) intervention in adults with Rheumatoid Arthritis (RA) on disease activity.
The investigators hypothesize that if patients with RA follow a 100% PBD over a 16-week period it will lead to improvements in:
- Disease activity (measured by DAS28), including reduction in symptoms and overall improvements in health-related quality of life.
The effects of the PBD will be compared to a habitual diet, that includes no dietary changes.
Participants in the intervention group will:
- Receive weekly delivery of food boxes which include plant-based food items
- Receive a daily multivitamin supplement
- Receive continuous dietetic guidance
- Participate in a practical cooking class to get an introduction to a PBD
- Participate in three online supervisions throughout the intervention period
Participants in the control group will follow the same plan for the project visits at the hospital but will be restricted to continue their habitual diet. Thus, not performing any dietary changes.
详细描述
Rheumatoid Arthritis (RA) is a chronic, autoimmune disease, requiring lifelong medical treatment. Evidence has suggested that supporting patients with RA to take an active role in their management of their disease can improve the patients' overall health and quality of life. In addition, patients often ask for support to identify effective ways to reduce symptoms, which include lifestyle changes, of which nutrition may be important. From a patient perspective, the lack of consistent evidence on nutrition also affects patients' choices regarding diet. Patients with RA have expressed that their is insufficient guiding regarding dietary choices. Hypotheses about the effect of various diets on disease activity in RA have been suggested, hence, the influence of pro-inflammatory and anti-inflammatory ingredients have been clinically investigated, however, with very limited studies investigating the effect of a 100% plant-based diet (PBD) on disease activity in RA.
The objective of this study is to investigate if 16-weeks of PBD reduces disease activity and RA-related symptoms, and improves cardio-metabolic health, physical function, mental health, sleep quality and health-related quality of life (HRQoL) in patients with RA.
Thus, in this RCT the patients in the intervention group will be instructed to adhere to a 100% PBD and without changing e.g., exercise habits.
The 16-week intervention consists of
- Weekly delivery of food boxes including plant-based food items for the entire household. Including various different recipes for a balanced PBD.
- A daily multivitamin supplement.
- Continuous dietetic guidance either in person, by phone or e-mail.
- The patients will participate in a practical cooking class to get an introduction to a PBD. Here they will be in groups of approx. 5-8 patients.
- Throughout the intervention period the patients will in addition participate in three online supervisions with the same group they were together with in the cooking class.
- The patients will register their food and drink intake two days before each project visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Care Provider)
盲法说明
Project nurses
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
- •Age ≥18 years
- •DAS28 score ≤3.2, and without swollen joints
- •RA diagnosis of minimum one year
- •Stable pharmacological treatment for at least four months and with no planned change in treatment within eight weeks
排除标准
- •Diabetes mellitus
- •Pregnancy / planned pregnancy
- •Prednisolone treatment
- •DAS28 above 3.2
- •Current dietary habits resembling intervention diet (e.g., PBD lifestyle)
- •Food allergies and intolerances
- •Unable to understand the informed consent and study procedures
研究组 & 干预措施
Intervention group
干预措施: Plant-based diet (Other)
Control group
结局指标
主要结局
Disease activity measured by DAS28
时间窗: 16 weeks
The Disease Activity Score 28 (DAS28) is a composite index used to assess disease activity in patients with rheumatoid arthritis. The DAS28 is a quantification of tender and swollen joints within the hands, shoulders, elbows, wrists, and knees. These assessments, in conjunction with CRP values obtained from blood samples and the self-reported global Visual Analog Scale (VAS) score, will be incorporated into the computation of DAS28. The DAS28 ranges from 0 to 10, with higher scores indicating higher disease activity.
次要结局
- Ultrasound - supportive of the primary outcome(16 weeks)
研究者
Allan Linneberg
Professor, MD
Center for Clinical Research and Prevention