The current study pretends to clarify, whether or not a healthy anti inflammatory diet improves different health-related outcomes in participants with rheumatoid arthritis.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
29
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.
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.
Changes in disease activity
Disease activity is determined by Simplified Disease Activity Index (SDAI)
Time frame: Day 0, month 4, month 8 and month12.
Changes in disease activity
Disease activity is determined by DAS28 score\_ c reactive protein (DAS28-CRP)
Time frame: Day 0, month 4, month 8 and month12.
Changes in disease activity
Disease activity is determined by DAS28 score\_ erythrocyte sedimentation rate (DAS28-ESR)
Time frame: Day 0, month 4, month 8 and month12.
Changes in disease activity
Disease activity is determined by Clinical Disease Activity Index (CDAI)
Time frame: Day 0, month 4, month 8 and month12.
Changes in functional capacity
Functional capacity is assessed by the Health Assessment Questionnaire (HAQ).
Time frame: 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)
Time frame: 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)
Time frame: 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).
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Time frame: 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.
Time frame: 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.
Time frame: Day 0, month 4, month 8 and month12.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 0, month 4, month 8 and month12.
Changes in anthropometric measurements
Body fat percentage (BFP) analyzed by bioelectrical impedance analysis (BIA).
Time frame: 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
Time frame: Day 0, month 4, month 8 and month12.