Anti-Inflammatory Diet Effect in Rheumatoid Arthritis Patients
- Conditions
- Rheumatoid Arthritis
- Interventions
- Other: Control DietOther: Antiinflammatory Diet
- Registration Number
- NCT05254223
- Lead Sponsor
- Jose manuel Lou Bonafonte
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
- Rheumatoid arthritis patients
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Diet (NDA) Control Diet No dietary advice (NDA) Anti-inflammatory Diet (AIDA) Antiinflammatory Diet Anti-inflammatory Dietary advice (AIDA)
- Primary Outcome Measures
Name Time Method Changes in functional capacity Day 0, month 4, month 8 and month12. Functional capacity is assessed by the Health Assessment Questionnaire (HAQ).
Changes in self-perceived health Day 0, month 4, month 8 and month12. Self-perceived health is evaluated by questionnaire EuroQol-5D-3L (EQ-5D)
Changes in disease activity Day 0, month 4, month 8 and month12. Disease activity is determined by Clinical Disease Activity Index (CDAI)
Global analysis of the dietary pattern during the intervention (FFQ) 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) 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. 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) 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.
- Secondary Outcome Measures
Name Time Method Changes in self-reported stiffness. Every week from day 0 and during 12 months. Participants report weekly self perception about stiffness answering to a scale where 0 means no stiffness and 10 is the maximum stiffness imaginable.
Changes in self-reported inflammation Every week from day 0 and during 12 months. Participants report weekly self perception about inflammation answering to a scale where 0 means no stiffness and 10 is the maximum stiffness imaginable.
Changes in Lipidomics profile Day 0, month 4, month 8 and month12. Lipidomics profiling will be determined by plasma gas chromatography mass spectrometry (GC/MS). Lipidomics profiling in serum samples will be correlated with lipid intake.
Changes in cytokines/Interleukins (ILs) Day 0, month 4, month 8 and month12. 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.
Changes in self-reported pain, Every week from day 0 and during 12 months. 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.
Changes in anthropometric mesurements Day 0, month 4, month 8 and month12. Participant's height (m) and weight (Kg) will be measured and body mass index (BMI) will be calculated.
Changes in anthropometric measurements Day 0, month 4, month 8 and month12. 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