The Triad of Nutrition, Intestinal Microbiota and Rheumatoid Arthritis (TASTY)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- DAS28-ESR
研究概览
简要总结
The main goal of this trial is to investigate whether a dietary intervention based on a typical Mediterranean Diet enriched with fermented foods (MedDiet+) can impact gut microbiota and RA-related outcomes.
详细描述
100 RA patients will be recruited at ULS Santa Maria in Lisbon, Portugal, and randomly assigned to either the intervention (MedDiet+) or the control group. The 12-week nutritional intervention will include a personalized dietary plan based on the MedDiet+ pattern, educational resources, food basket deliveries, and clinical culinary workshops, all developed and monitored weekly by registered dietitians. The control group will receive general recommendations for a healthy diet at baseline. The intervention's effects will be assessed by evaluating disease activity, functional status, quality of life, intestinal permeability, endotoxemia, inflammatory biomarkers, intestinal and oral microbiota, serum proteomics, and serum glycome profile characterisation.
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
- Single (Outcomes Assessor)
盲法说明
Block randomization was performed through an online software, and patients are being allocated into the intervention (MedDiet+) or control groups. Due to the nature of the trial, the participants and the dietitians responsible for implementing the study are not blinded. However, the clinicians evaluating the clinical outcome measures (disease activity score in 28 joints and the doppler ultrasound score in 32 joints) and the researchers performing the laboratory tests are blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •RA patients (ACR/EULAR2010 criteria)
- •Age >18-years
- •Disease duration >1-year
- •Active disease (DAS28 > 2.6units)
- •On stable medication for 12 weeks
- •Low/medium MedDiet adherence (PREDIMED<10)
- •Willing to comply with study protocol
排除标准
- •Prednisolone dose ≥ 7.5 mg/day
- •Antibiotic therapy 4-weeks prior to baseline
- •Persistent use of NSAID's
- •Inflammatory or irritable bowel disease
- •Celiac disease
- •Chronic diarrhea
- •Other immune-mediated inflammatory diseases besides RA
- •Major organ dysfunction
- •Cancer diagnosed in the last five years
- •Health conditions which may difficult participation (cognitive impairment/psychiatric disease)
- •Pregnant or lactating individuals
研究组 & 干预措施
MedDiet+ intervention
The 12-week nutritional intervention includes a personalized dietary plan based on the MedDiet+ pattern, educational resources, food basket deliveries, and clinical culinary workshops, all developed and monitored weekly by registered dietitians. The nutritional plan includes the food portions of each food group in agreement with the MedDiet recommendations for the adult population, complemented with fermented foods including kefir (provided for daily consumption) and kombucha (provided for consumption 2x/week).
干预措施: MedDiet+ intervention (Other)
General dietary recommendations
This group receives a flyer with general recommendations on a healthy diet based on the Portuguese brief guidance for healthy eating in primary health care at baseline
干预措施: General dietary recommendations (Other)
结局指标
主要结局
DAS28-ESR
时间窗: 12 weeks
Disease Activity Score in 28 Joints Calculated with erythrocyte sedimentation rate (DAS28-ESR), higher scores indicate higher disease activity
次要结局
- EULAR Good or Moderate Response(12 weeks)
- Ultrasound score(12 weeks)
- DAS28-CRP(12 weeks)
- Quality of life(12 weeks)
- Functional status(12 weeks)
- α- and β- diversity of the gut and oral microbiota(12 weeks)
- Changes in key gut microbial species(12 weeks)
- Intestinal permeability(12 weeks)
- Endotoxemia(12 weeks)
- CRP(12 weeks)
- ESR(12 weeks)
- Faecal calprotectin(12 weeks)
- CD14s(12 weeks)
- LBP(12 weeks)
- IFABP(12 weeks)
- Lipid Profile(12 weeks)
- Body composition(4 th, 8 th and 12 th weeks)
- Anthropometric measurements(4 th, 8 th and 12 th weeks)
- Waist circunference(4 th, 8 th and 12 th weeks)
研究者
Ana Lopes
Centro Académico de Medicina de Lisboa
Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa