NCT05254223

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Dec 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2018

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 24, 2022

Completed
Last Updated

February 24, 2022

Status Verified

February 1, 2022

Enrollment Period

10 months

First QC Date

January 13, 2022

Last Update Submit

February 17, 2022

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisDietAntiinflammatory dietNutrition

Outcome Measures

Primary Outcomes (10)

  • 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 Outcomes (8)

  • Changes in self-reported pain,

    Every week from day 0 and during 12 months.

  • Changes in self-reported stiffness.

    Every week from day 0 and during 12 months.

  • Changes in self-reported inflammation

    Every week from day 0 and during 12 months.

  • Changes in Lipidomics profile

    Day 0, month 4, month 8 and month12.

  • Changes in cytokines/Interleukins (ILs)

    Day 0, month 4, month 8 and month12.

  • +3 more secondary outcomes

Study Arms (2)

Control Diet (NDA)

EXPERIMENTAL

No dietary advice (NDA)

Other: Control Diet

Anti-inflammatory Diet (AIDA)

EXPERIMENTAL

Anti-inflammatory Dietary advice (AIDA)

Other: Antiinflammatory Diet

Interventions

Antiinflammatory DietOTHER

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.

Anti-inflammatory Diet (AIDA)
Control DietOTHER

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.

Control Diet (NDA)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Rheumatoid arthritis patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

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

    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.

    PMID: 8286893BACKGROUND

  • 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.

    PMID: 18791055BACKGROUND

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 13, 2022

First Posted

February 24, 2022

Study Start

December 12, 2016

Primary Completion

October 19, 2017

Study Completion

June 19, 2018

Last Updated

February 24, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share