Anti-Inflammatory Diet Effect in Rheumatoid Arthritis Patients

Study Overview
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Brief Summary
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The current study pretends to clarify, whether or not a healthy anti inflammatory diet improves different health-related outcomes in participants with rheumatoid arthritis.

Detailed Description
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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.

Official Title
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Effect of Long Term Anti-inflammatory-diet Advice in Patients With Rheumatoid Arthritis.

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Other: Antiinflammatory Diet
* Other: Control Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rheumatoid arthritis patients Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control Diet (NDA)<br>No dietary advice (NDA) | Other: Control Diet<br>* The control group is recommended to follow their usual diet. Only in the case of detecting a serious nutritional problem the participant is recommended to correct it with the appropriate advice of the nutritionist.<br>|
| Experimental: Anti-inflammatory Diet (AIDA)<br>Anti-inflammatory Dietary advice (AIDA) | Other: Antiinflammatory Diet<br>* The intervention group is recommended to follow a diet, inspired in mediterranean diet, rich in anti-inflammatory foods. They are provided with a table with the recommended foods as well as the frequency of daily/weekly/biweekly consumption.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in disease activity | Disease activity is determined by Simplified Disease Activity Index (SDAI) | Day 0, month 4, month 8 and month12. | 
| Changes in disease activity | Disease activity is determined by DAS28 score_ c reactive protein (DAS28-CRP) | Day 0, month 4, month 8 and month12. | 
| Changes in disease activity | Disease activity is determined by DAS28 score_ erythrocyte sedimentation rate (DAS28-ESR) | Day 0, month 4, month 8 and month12. | 
| Changes in disease activity | Disease activity is determined by Clinical Disease Activity Index (CDAI) | Day 0, month 4, month 8 and month12. | 
| Changes in functional capacity | Functional capacity is assessed by the Health Assessment Questionnaire (HAQ). | Day 0, month 4, month 8 and month12. | 
| Changes in self-perceived health | Self-perceived health is evaluated by questionnaire EuroQol-5D-3L (EQ-5D) | Day 0, month 4, month 8 and month12. | 
| Global analysis of the dietary pattern during the intervention (FFQ) | Global analysis of the dietary pattern during the intervention is evaluated by the food frequency questionaire (FFQ) | Month 12. | 
| Detailed analysis of diet. | 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). | Day 0, month 4, month 8 and month12. | 
| Changes in Mediterranean Diet Adherence Score (MEDAS) | Changes in MEDAS are carried out by MEDAS. 0 points means no adherence, 14 points means maximal adherence. | Day 0, month 4, month 8 and month12. | 
| Changes in Dietary inflammatory Index (DII) | Dietary inflammatory index are calculated with the information provides by 24 hour dietary recall 3 days/week. | Day 0, month 4, month 8 and month12. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in self-reported pain, | Participants report weekly self perception about pain, answering to a visual analogical scale where 0 means no pain and 10 is the maximum pain imaginable. | Every week from day 0 and during 12 months. | 
| Changes in self-reported stiffness. | Participants report weekly self perception about stiffness answering to a scale where 0 means no stiffness and 10 is the maximum stiffness imaginable. | Every week from day 0 and during 12 months. | 
| Changes in self-reported inflammation | Participants report weekly self perception about inflammation answering to a scale where 0 means no stiffness and 10 is the maximum stiffness imaginable. | Every week from day 0 and during 12 months. | 
| Changes in Lipidomics profile | Lipidomics profiling will be determined by plasma gas chromatography mass spectrometry (GC/MS). Lipidomics profiling in serum samples will be correlated with lipid intake. | Day 0, month 4, month 8 and month12. | 
| Changes in cytokines/Interleukins (ILs) | IL-1B, IL-4, IL-6, IL-10, IL-17, TNF-a, MCP1 will be analyzed by multiplex assay. Results will be correlated with Disease activity Indexes/scores. | Day 0, month 4, month 8 and month12. | 
| Changes in anthropometric mesurements | Participant's height (m) and weight (Kg) will be measured and body mass index (BMI) will be calculated. | Day 0, month 4, month 8 and month12. | 
| Changes in anthropometric measurements | Body fat percentage (BFP) analyzed by bioelectrical impedance analysis (BIA). | Day 0, month 4, month 8 and month12. | 
| Changes in anthropometric measurements | Body fat percentage (BFP) analyzed by anthropometric analysis acording to ISAK procedures (international standards for anthropometric assessment ) and using Siri formula where Fat %= [(4,95/density) - 4,5] * 100 | Day 0, month 4, month 8 and month12. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet, Rheumatoid Arthritis, Antiinflammatory diet, Nutrition