Effect of Long Term "Anti-inflammatory-diet" Advice in Patients With Rheumatoid Arthritis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 主要终点
- Changes in functional capacity
研究概览
简要总结
The current study pretends to clarify, whether or not a healthy anti inflammatory diet improves different health-related outcomes in participants with rheumatoid arthritis.
详细描述
The current study pretends to clarify, whether or not a healthy anti-inflammatory diet improves different health-related outcomes: clinical, analytical, anthropometric and psychological outcomes in participants with rheumatoid arthritis. Due to the intervention has been based in a dietary advise, one of the goals of this study is also to evaluate the role of dietary advice in changing effectively the dietary patterns of the patients.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rheumatoid arthritis patients
排除标准
- •Any additional pathology or situation that could be considered, according to clinical criteria, of risk for the patient or for the study. for example:
- •Chronic renal failure
- •Liver failure
- •Heart failure
- •Pregnancy
结局指标
主要结局
Changes in functional capacity
时间窗: Day 0, month 4, month 8 and month12.
Functional capacity is assessed by the Health Assessment Questionnaire (HAQ).
Changes in self-perceived health
时间窗: Day 0, month 4, month 8 and month12.
Self-perceived health is evaluated by questionnaire EuroQol-5D-3L (EQ-5D)
Global analysis of the dietary pattern during the intervention (FFQ)
时间窗: Month 12.
Global analysis of the dietary pattern during the intervention is evaluated by the food frequency questionaire (FFQ)
Changes in Dietary inflammatory Index (DII)
时间窗: Day 0, month 4, month 8 and month12.
Dietary inflammatory index are calculated with the information provides by 24 hour dietary recall 3 days/week.
Detailed analysis of diet.
时间窗: Day 0, month 4, month 8 and month12.
Detailled analysis of diet is carried out by 24 hour dietary recall 3 days/week. Diet will be analyzed by HD-ENRICA diet analisys software (v17). Data analyzed will be: Energy (Kcal), Proteins (g), Carbohydrates (g), Fats (g), Fibre (g), vitamins (mg), minerals (mg), water (ml).
Changes in Mediterranean Diet Adherence Score (MEDAS)
时间窗: Day 0, month 4, month 8 and month12.
Changes in MEDAS are carried out by MEDAS. 0 points means no adherence, 14 points means maximal adherence.
Changes in disease activity
时间窗: Day 0, month 4, month 8 and month12.
Disease activity is determined by Simplified Disease Activity Index (SDAI)
次要结局
- Changes in self-reported stiffness.(Every week from day 0 and during 12 months.)
- Changes in self-reported inflammation(Every week from day 0 and during 12 months.)
- Changes in Lipidomics profile(Day 0, month 4, month 8 and month12.)
- Changes in cytokines/Interleukins (ILs)(Day 0, month 4, month 8 and month12.)
- Changes in self-reported pain,(Every week from day 0 and during 12 months.)
- Changes in anthropometric mesurements(Day 0, month 4, month 8 and month12.)
- Changes in anthropometric measurements(Day 0, month 4, month 8 and month12.)
研究者
Jose manuel Lou Bonafonte
Principal Investigator
Instituto de Investigación Sanitaria Aragón