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| Name | Class |
|---|---|
| Universidad de Zaragoza | OTHER |
| Centro de Investigación Biomédica en Red de FisiopatologÃa de la Obesidad y Nutrición | OTHER |
| Instituto Agroalimentario de Aragón (IA2). | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Diet (NDA) | Experimental | No dietary advice (NDA) |
|
| Anti-inflammatory Diet (AIDA) | Experimental | Anti-inflammatory Dietary advice (AIDA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antiinflammatory Diet | Other | 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. |
| 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. |
| 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. |
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Inclusion Criteria:
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:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | ISAK. (2011). International Standards For Anthropometric Assessment. International Society for the Advancement of Kinanthropometry. | ||
| 8286893 | Background | Siri WE. Body composition from fluid spaces and density: analysis of methods. 1961. Nutrition. 1993 Sep-Oct;9(5):480-91; discussion 480, 492. No abstract available. | |
| 18791055 |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Hospital San Jorge (Huesca) |
| UNKNOWN |
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| Control Diet | Other | 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. |
|
| 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. |
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. |
| Background |
| Aletaha D, Landewe R, Karonitsch T, Bathon J, Boers M, Bombardier C, Bombardieri S, Choi H, Combe B, Dougados M, Emery P, Gomez-Reino J, Keystone E, Koch G, Kvien TK, Martin-Mola E, Matucci-Cerinic M, Michaud K, O'Dell J, Paulus H, Pincus T, Richards P, Simon L, Siegel J, Smolen JS, Sokka T, Strand V, Tugwell P, van der Heijde D, van Riel P, Vlad S, van Vollenhoven R, Ward M, Weinblatt M, Wells G, White B, Wolfe F, Zhang B, Zink A, Felson D. Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations. Ann Rheum Dis. 2008 Oct;67(10):1360-4. doi: 10.1136/ard.2008.091454. |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |