Anti-Inflammatory Diet Effect in Rheumatoid Arthritis Patients

NCT ID: NCT05254223

Last Updated: 2022-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-12

Study Completion Date

2018-06-19

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control Diet (NDA)

No dietary advice (NDA)

Group Type EXPERIMENTAL

Control Diet

Intervention Type 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.

Anti-inflammatory Diet (AIDA)

Anti-inflammatory Dietary advice (AIDA)

Group Type EXPERIMENTAL

Antiinflammatory Diet

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Zaragoza

OTHER

Sponsor Role collaborator

Centro de Investigación Biomédica en Red de la Obesidad y Nutrición. ISCIII

UNKNOWN

Sponsor Role collaborator

Instituto Agroalimentario de Aragón (IA2).

UNKNOWN

Sponsor Role collaborator

Hospital San Jorge (Huesca)

UNKNOWN

Sponsor Role collaborator

Jose manuel Lou Bonafonte

OTHER

Sponsor Role lead

Responsible Party

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Jose manuel Lou Bonafonte

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

References

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 8286893 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18791055 (View on PubMed)

Other Identifiers

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NSP-2016-1

Identifier Type: -

Identifier Source: org_study_id

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