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

February 17, 2022 updated by: Jose manuel Lou Bonafonte

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

The current study pretends to clarify, whether or not a healthy anti inflammatory diet improves different health-related outcomes in participants with rheumatoid arthritis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in disease activity
Time Frame: Day 0, month 4, month 8 and month12.
Disease activity is determined by Simplified Disease Activity Index (SDAI)
Day 0, month 4, month 8 and month12.
Changes in disease activity
Time Frame: Day 0, month 4, month 8 and month12.
Disease activity is determined by DAS28 score_ c reactive protein (DAS28-CRP)
Day 0, month 4, month 8 and month12.
Changes in disease activity
Time Frame: Day 0, month 4, month 8 and month12.
Disease activity is determined by DAS28 score_ erythrocyte sedimentation rate (DAS28-ESR)
Day 0, month 4, month 8 and month12.
Changes in disease activity
Time Frame: Day 0, month 4, month 8 and month12.
Disease activity is determined by Clinical Disease Activity Index (CDAI)
Day 0, month 4, month 8 and month12.
Changes in functional capacity
Time Frame: Day 0, month 4, month 8 and month12.
Functional capacity is assessed by the Health Assessment Questionnaire (HAQ).
Day 0, month 4, month 8 and month12.
Changes in self-perceived health
Time Frame: Day 0, month 4, month 8 and month12.
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)
Time Frame: Month 12.
Global analysis of the dietary pattern during the intervention is evaluated by the food frequency questionaire (FFQ)
Month 12.
Detailed analysis of diet.
Time Frame: 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).
Day 0, month 4, month 8 and month12.
Changes in Mediterranean Diet Adherence Score (MEDAS)
Time Frame: 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.
Day 0, month 4, month 8 and month12.
Changes in Dietary inflammatory Index (DII)
Time Frame: 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.
Day 0, month 4, month 8 and month12.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in self-reported pain,
Time Frame: 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.
Every week from day 0 and during 12 months.
Changes in self-reported stiffness.
Time Frame: 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.
Every week from day 0 and during 12 months.
Changes in self-reported inflammation
Time Frame: 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.
Every week from day 0 and during 12 months.
Changes in Lipidomics profile
Time Frame: 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.
Day 0, month 4, month 8 and month12.
Changes in cytokines/Interleukins (ILs)
Time Frame: 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.
Day 0, month 4, month 8 and month12.
Changes in anthropometric mesurements
Time Frame: 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.
Day 0, month 4, month 8 and month12.
Changes in anthropometric measurements
Time Frame: Day 0, month 4, month 8 and month12.
Body fat percentage (BFP) analyzed by bioelectrical impedance analysis (BIA).
Day 0, month 4, month 8 and month12.
Changes in anthropometric measurements
Time Frame: 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
Day 0, month 4, month 8 and month12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jose manuel Lou Bonafonte

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universidad de Zaragoza
Centro de Investigación Biomédica en Red de la Obesidad y Nutrición. ISCIII
Instituto Agroalimentario de Aragón (IA2).
Hospital San Jorge (Huesca)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 12, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 19, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 19, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NSP-2016-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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