Anti-Inflammatory Diet Effect in Rheumatoid Arthritis Patients

Rheumatoid Arthritis Clinical Trial

— AIDE-RAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05254223
• Other study ID #: NSP-2016-1
• Status: Completed
• Phase: N/A
• Start date: December 12, 2016
• Est. completion date: June 19, 2018

Study information

• Verified date: February 2022
• Source: Instituto de Investigación Sanitaria Aragón
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 19, 2018
• Est. primary completion date: October 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (5)

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

References & Publications (3)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in disease activity	Disease activity is determined by Simplified Disease Activity Index (SDAI)	Day 0, month 4, month 8 and month12.
Primary	Changes in disease activity	Disease activity is determined by DAS28 score_ c reactive protein (DAS28-CRP)	Day 0, month 4, month 8 and month12.
Primary	Changes in disease activity	Disease activity is determined by DAS28 score_ erythrocyte sedimentation rate (DAS28-ESR)	Day 0, month 4, month 8 and month12.
Primary	Changes in disease activity	Disease activity is determined by Clinical Disease Activity Index (CDAI)	Day 0, month 4, month 8 and month12.
Primary	Changes in functional capacity	Functional capacity is assessed by the Health Assessment Questionnaire (HAQ).	Day 0, month 4, month 8 and month12.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Changes in anthropometric measurements	Body fat percentage (BFP) analyzed by bioelectrical impedance analysis (BIA).	Day 0, month 4, month 8 and month12.
Secondary	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.

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