AIDE-RAP: Anti-Inflammatory Diet Effect in Rheumatoid Arthritis Patients

Sponsor

Jose manuel Lou Bonafonte (Other)

Overall Status

Completed

CT.gov ID

NCT05254223

Collaborator

Universidad de Zaragoza (Other), Centro de Investigación Biomédica en Red de la Obesidad y Nutrición. ISCIII (Other), Instituto Agroalimentario de Aragón (IA2). (Other), Hospital San Jorge (Huesca) (Other)

Enrollment

Arms

18.2

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Other: Antiinflammatory Diet Other: Control Diet	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Dec 12, 2016

Actual Primary Completion Date :

Oct 19, 2017

Actual Study Completion Date :

Jun 19, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Control Diet (NDA) No dietary advice (NDA)	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.
Experimental: Anti-inflammatory Diet (AIDA) Anti-inflammatory Dietary advice (AIDA)	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.

Arm

Intervention/Treatment

Experimental: Control Diet (NDA)

No dietary advice (NDA)

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.

Experimental: Anti-inflammatory Diet (AIDA)

Anti-inflammatory Dietary advice (AIDA)

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.

Outcome Measures

Primary Outcome Measures

Changes in disease activity [Day 0, month 4, month 8 and month12.]
Disease activity is determined by Simplified Disease Activity Index (SDAI)
Changes in disease activity [Day 0, month 4, month 8 and month12.]
Disease activity is determined by DAS28 score_ c reactive protein (DAS28-CRP)
Changes in disease activity [Day 0, month 4, month 8 and month12.]
Disease activity is determined by DAS28 score_ erythrocyte sedimentation rate (DAS28-ESR)
Changes in disease activity [Day 0, month 4, month 8 and month12.]
Disease activity is determined by Clinical Disease Activity Index (CDAI)
Changes in functional capacity [Day 0, month 4, month 8 and month12.]
Functional capacity is assessed by the Health Assessment Questionnaire (HAQ).
Changes in self-perceived health [Day 0, month 4, month 8 and month12.]
Self-perceived health is evaluated by questionnaire EuroQol-5D-3L (EQ-5D)
Global analysis of the dietary pattern during the intervention (FFQ) [Month 12.]
Global analysis of the dietary pattern during the intervention is evaluated by the food frequency questionaire (FFQ)
Detailed analysis of diet. [Day 0, month 4, month 8 and month12.]
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) [Day 0, month 4, month 8 and month12.]
Changes in MEDAS are carried out by MEDAS. 0 points means no adherence, 14 points means maximal adherence.
Changes in Dietary inflammatory Index (DII) [Day 0, month 4, month 8 and month12.]
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, [Every week from day 0 and during 12 months.]
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. [Every week from day 0 and during 12 months.]
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 [Every week from day 0 and during 12 months.]
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 [Day 0, month 4, month 8 and month12.]
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) [Day 0, month 4, month 8 and month12.]
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 [Day 0, month 4, month 8 and month12.]
Participant's height (m) and weight (Kg) will be measured and body mass index (BMI) will be calculated.
Changes in anthropometric measurements [Day 0, month 4, month 8 and month12.]
Body fat percentage (BFP) analyzed by bioelectrical impedance analysis (BIA).
Changes in anthropometric measurements [Day 0, month 4, month 8 and month12.]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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: