The Effect of an Anti-inflammatory Diet on Disease Activity and Quality of Life in Patients With Rheumatoid Arthritis - Parallel Controlled Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Changes in disease activity
研究概览
简要总结
Rheumatoid arthritis (RA) is an autoimmune disease that affects 0.5-1% of the population and in which his remission is not always achieved, affecting physical and mental well-being and quality of life (QL). As a complement to pharmacotherapy, dietary intervention should be evaluated as a treatment option.
The main objective of this parallel controlled randomized clinical trial is to check the effect of an anti-inflammatory dietary intervention, compared to a diet based on the principles of the Mediterranean diet (control), on disease activity (AD) and improving QL.
Patients will be instructed to follow an anti-inflammatory diet (DAI) or a control diet (DC) for 6 months. The AD and QL will be evaluated at the end of the intervention.
As there are no dietary guidelines for RA, this study aims to provide scientific evidence about the impact of diet therapy on reducing AD and improving QL.
详细描述
The main objective of this trial is to check the effect of an DAI, compared to a DC, on reducing AD and improving QL.
As secondary objectives, it is intended to investigate the relationship of DAI with inflammatory markers and with the modulation of the composition / diversity of the intestinal microbiota, in comparison with a DC.
This study combines all dietary components with an anti-inflammatory effect, thus allowing the possibility of evaluating the full potential of dietary treatment in the disease, including intestinal microbiota modulation.
These results are intended to further contribute to clinical decision making and better evidence-based treatment.
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
- Double (Participant, Investigator)
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 over 18 years;
- •Presence of active disease, (DAS28≥ 2.6), under adequate control and medication.
- •Able to sign informed consent
排除标准
- •Any type of psychological deficiency, dementia or eating disorder;
- •Presence of food allergies and / or intolerances;
- •Be vegetarian or use Phytotherapy or other supplements (namely, pre and probiotics);
- •Use of antibiotics im the last 6 months;
- •Have had previous nutritional monitoring or change in eating habits in the last 6 months.
结局指标
主要结局
Changes in disease activity
时间窗: 15 weeks
Difference between the intervention and control group in the changes in Disease Activity (using DAS28 score: greater than 2,6 implies active disease), from baseline to the end of follow-up
Changes in Quality of Life
时间窗: 15 weeks
Difference between the intervention and control group in changes in Quality of Life (Health Assessment Questionnaire (HAQ): scores of 0 to 1 are generally considered to represent mild to moderate difficulty, 1 to 2 moderate to severe disability, and 2 to 3 severe to very severe disability), from baseline to the end of follow-up
次要结局
- Changes in Gut microbiota(15 weeks)
- Changes in weight(15 weeks)
- Changes in C-Reactive Protein (CRP)(15 weeks)
- Changes in Erythrocyte Sedimentation Rate (ESR)(15 weeks)
- Changes in Rheumatoid Factor (RF)(15 weeks)
- Changes in Body Mass Index (BMI)(15 weeks)
- Changes in waist circumference perimeter(15 weeks)