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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Antiinflammatory Diet
Control Diet
Sponsored by
Jose manuel Lou Bonafonte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Diet, Antiinflammatory diet, Nutrition

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Control Diet (NDA)

    Anti-inflammatory Diet (AIDA)

    Arm Description

    No dietary advice (NDA)

    Anti-inflammatory Dietary advice (AIDA)

    Outcomes

    Primary Outcome Measures

    Changes in disease activity
    Disease activity is determined by Simplified Disease Activity Index (SDAI)
    Changes in disease activity
    Disease activity is determined by DAS28 score_ c reactive protein (DAS28-CRP)
    Changes in disease activity
    Disease activity is determined by DAS28 score_ erythrocyte sedimentation rate (DAS28-ESR)
    Changes in disease activity
    Disease activity is determined by Clinical Disease Activity Index (CDAI)
    Changes in functional capacity
    Functional capacity is assessed by the Health Assessment Questionnaire (HAQ).
    Changes in self-perceived health
    Self-perceived health is evaluated by questionnaire EuroQol-5D-3L (EQ-5D)
    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)
    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).
    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.
    Changes in Dietary inflammatory Index (DII)
    Dietary inflammatory index are calculated with the information provides by 24 hour dietary recall 3 days/week.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    Changes in anthropometric mesurements
    Participant's height (m) and weight (Kg) will be measured and body mass index (BMI) will be calculated.
    Changes in anthropometric measurements
    Body fat percentage (BFP) analyzed by bioelectrical impedance analysis (BIA).
    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

    Full Information

    First Posted
    January 13, 2022
    Last Updated
    February 17, 2022
    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)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05254223
    Brief Title
    Anti-Inflammatory Diet Effect in Rheumatoid Arthritis Patients
    Acronym
    AIDE-RAP
    Official Title
    Effect of Long Term "Anti-inflammatory-diet" Advice in Patients With Rheumatoid Arthritis.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    December 12, 2016 (Actual)
    Primary Completion Date
    October 19, 2017 (Actual)
    Study Completion Date
    June 19, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the 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)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis
    Keywords
    Rheumatoid Arthritis, Diet, Antiinflammatory diet, Nutrition

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    29 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Diet (NDA)
    Arm Type
    Experimental
    Arm Description
    No dietary advice (NDA)
    Arm Title
    Anti-inflammatory Diet (AIDA)
    Arm Type
    Experimental
    Arm Description
    Anti-inflammatory Dietary advice (AIDA)
    Intervention Type
    Other
    Intervention Name(s)
    Antiinflammatory Diet
    Intervention Description
    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
    Intervention Name(s)
    Control Diet
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Changes in disease activity
    Description
    Disease activity is determined by Simplified Disease Activity Index (SDAI)
    Time Frame
    Day 0, month 4, month 8 and month12.
    Title
    Changes in disease activity
    Description
    Disease activity is determined by DAS28 score_ c reactive protein (DAS28-CRP)
    Time Frame
    Day 0, month 4, month 8 and month12.
    Title
    Changes in disease activity
    Description
    Disease activity is determined by DAS28 score_ erythrocyte sedimentation rate (DAS28-ESR)
    Time Frame
    Day 0, month 4, month 8 and month12.
    Title
    Changes in disease activity
    Description
    Disease activity is determined by Clinical Disease Activity Index (CDAI)
    Time Frame
    Day 0, month 4, month 8 and month12.
    Title
    Changes in functional capacity
    Description
    Functional capacity is assessed by the Health Assessment Questionnaire (HAQ).
    Time Frame
    Day 0, month 4, month 8 and month12.
    Title
    Changes in self-perceived health
    Description
    Self-perceived health is evaluated by questionnaire EuroQol-5D-3L (EQ-5D)
    Time Frame
    Day 0, month 4, month 8 and month12.
    Title
    Global analysis of the dietary pattern during the intervention (FFQ)
    Description
    Global analysis of the dietary pattern during the intervention is evaluated by the food frequency questionaire (FFQ)
    Time Frame
    Month 12.
    Title
    Detailed analysis of diet.
    Description
    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).
    Time Frame
    Day 0, month 4, month 8 and month12.
    Title
    Changes in Mediterranean Diet Adherence Score (MEDAS)
    Description
    Changes in MEDAS are carried out by MEDAS. 0 points means no adherence, 14 points means maximal adherence.
    Time Frame
    Day 0, month 4, month 8 and month12.
    Title
    Changes in Dietary inflammatory Index (DII)
    Description
    Dietary inflammatory index are calculated with the information provides by 24 hour dietary recall 3 days/week.
    Time Frame
    Day 0, month 4, month 8 and month12.
    Secondary Outcome Measure Information:
    Title
    Changes in self-reported pain,
    Description
    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.
    Time Frame
    Every week from day 0 and during 12 months.
    Title
    Changes in self-reported stiffness.
    Description
    Participants report weekly self perception about stiffness answering to a scale where 0 means no stiffness and 10 is the maximum stiffness imaginable.
    Time Frame
    Every week from day 0 and during 12 months.
    Title
    Changes in self-reported inflammation
    Description
    Participants report weekly self perception about inflammation answering to a scale where 0 means no stiffness and 10 is the maximum stiffness imaginable.
    Time Frame
    Every week from day 0 and during 12 months.
    Title
    Changes in Lipidomics profile
    Description
    Lipidomics profiling will be determined by plasma gas chromatography mass spectrometry (GC/MS). Lipidomics profiling in serum samples will be correlated with lipid intake.
    Time Frame
    Day 0, month 4, month 8 and month12.
    Title
    Changes in cytokines/Interleukins (ILs)
    Description
    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.
    Time Frame
    Day 0, month 4, month 8 and month12.
    Title
    Changes in anthropometric mesurements
    Description
    Participant's height (m) and weight (Kg) will be measured and body mass index (BMI) will be calculated.
    Time Frame
    Day 0, month 4, month 8 and month12.
    Title
    Changes in anthropometric measurements
    Description
    Body fat percentage (BFP) analyzed by bioelectrical impedance analysis (BIA).
    Time Frame
    Day 0, month 4, month 8 and month12.
    Title
    Changes in anthropometric measurements
    Description
    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
    Time Frame
    Day 0, month 4, month 8 and month12.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    Citation
    ISAK. (2011). International Standards For Anthropometric Assessment. International Society for the Advancement of Kinanthropometry.
    Results Reference
    background
    PubMed Identifier
    8286893
    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.
    Results Reference
    background
    PubMed Identifier
    18791055
    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.
    Results Reference
    background

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    Anti-Inflammatory Diet Effect in Rheumatoid Arthritis Patients

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