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
About this trial
This is an interventional supportive care trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Diet, Antiinflammatory diet, Nutrition
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
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
NCT ID
NCT05254223
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)
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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