Anti-Inflammatory Diet Effect in Rheumatoid Arthritis Patients (AIDE-RAP)

Effect of Long Term "Anti-inflammatory-diet" Advice in Patients With Rheumatoid Arthritis.

The current study pretends to clarify, whether or not a healthy anti inflammatory diet improves different health-related outcomes in participants with rheumatoid arthritis.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Other: Control Diet; Other: Antiinflammatory Diet

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Control Diet (NDA); No dietary advice (NDA)	Other: Control 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.
EXPERIMENTAL: Anti-inflammatory Diet (AIDA); Anti-inflammatory Dietary advice (AIDA)	Other: Antiinflammatory 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.
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.

Secondary Outcome Measures

Outcome Measure	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.	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.

Collaborators and Investigators

• Sponsor: Jose manuel Lou Bonafonte
• Collaborators: Universidad de Zaragoza; Centro de Investigación Biomédica en Red de la Obesidad y Nutrición. ISCIII; Instituto Agroalimentario de Aragón (IA2).; Hospital San Jorge (Huesca)

Publications and helpful links

General Publications

• ISAK. (2011). International Standards For Anthropometric Assessment. International Society for the Advancement of Kinanthropometry.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 12, 2016
• Primary Completion (ACTUAL): October 19, 2017
• Study Completion (ACTUAL): June 19, 2018

Study Registration Dates

• First Submitted: January 13, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (ACTUAL): February 24, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 24, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Nutrition; Rheumatoid Arthritis; Diet; Antiinflammatory diet
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Anti-Inflammatory Agents
• Other Study ID Numbers: NSP-2016-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No