Clinical trial NCT05254223: Anti-Inflammatory Diet Effect in Rheumatoid Arthritis Patients
Official title: Effect of Long Term "Anti-inflammatory-diet" Advice in Patients With Rheumatoid Arthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Diet
Antiinflammatory diet
Nutrition
Lead sponsor: Instituto de Investigación Sanitaria Aragón
Sponsor class: OTHER
Collaborators: name: Universidad de Zaragoza
name: Centro de Investigación Biomédica en Red de la Obesidad y Nutrición. ISCIII
name: Instituto Agroalimentario de Aragón (IA2).
name: Hospital San Jorge (Huesca)
First posted: 2022-02-24
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in disease activity
timeFrame: Day 0, month 4, month 8 and month12.
measure: Changes in disease activity
timeFrame: Day 0, month 4, month 8 and month12.
measure: Changes in disease activity
timeFrame: Day 0, month 4, month 8 and month12.
measure: Changes in disease activity
timeFrame: Day 0, month 4, month 8 and month12.
measure: Changes in functional capacity
timeFrame: Day 0, month 4, month 8 and month12.
measure: Changes in self-perceived health
timeFrame: Day 0, month 4, month 8 and month12.
measure: Global analysis of the dietary pattern during the intervention (FFQ)
timeFrame: Month 12.
measure: Detailed analysis of diet.
timeFrame: Day 0, month 4, month 8 and month12.
measure: Changes in Mediterranean Diet Adherence Score (MEDAS)
timeFrame: Day 0, month 4, month 8 and month12.
measure: Changes in Dietary inflammatory Index (DII)
timeFrame: Day 0, month 4, month 8 and month12.
Secondary outcomes:
measure: Changes in self-reported pain,
timeFrame: Every week from day 0 and during 12 months.
measure: Changes in self-reported stiffness.
timeFrame: Every week from day 0 and during 12 months.
measure: Changes in self-reported inflammation
timeFrame: Every week from day 0 and during 12 months.
measure: Changes in Lipidomics profile
timeFrame: Day 0, month 4, month 8 and month12.
measure: Changes in cytokines/Interleukins (ILs)
timeFrame: Day 0, month 4, month 8 and month12.
measure: Changes in anthropometric mesurements
timeFrame: Day 0, month 4, month 8 and month12.
measure: Changes in anthropometric measurements
timeFrame: Day 0, month 4, month 8 and month12.
measure: Changes in anthropometric measurements
timeFrame: Day 0, month 4, month 8 and month12.
Other outcomes:
Locations:
Study officials:
References:
citation: ISAK. (2011). International Standards For Anthropometric Assessment. International Society for the Advancement of Kinanthropometry.
citation: 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.
citation: 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.