Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Diet, Antiinflammatory diet, Nutrition
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.
Interventions
OTHERAntiinflammatory Diet
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.
OTHERControl Diet
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.
Sponsors
Universidad de Zaragoza
Centro de Investigación Biomédica en Red de la Obesidad y Nutrición. ISCIII
Instituto Agroalimentario de Aragón (IA2).
Hospital San Jorge (Huesca)
Jose manuel Lou Bonafonte
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Changes in disease activity | Day 0, month 4, month 8 and month12. | Disease activity is determined by Simplified Disease Activity Index (SDAI) |
| 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) |
| 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) |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 bioelectrical impedance analysis (BIA). |
Outcome results
None listed