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Rheumatoid ArthritisAIDE-RAPNCT05254223

Anti-Inflammatory Diet Effect in Rheumatoid Arthritis Patients

A study testing Antiinflammatory Diet in people with Rheumatoid Arthritis, run by Jose manuel Lou Bonafonte.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Antiinflammatory Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
No sites listed yet
Study dates
12 Dec 2016to 19 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Rheumatoid arthritis patients

Who cannot join

  • 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

About this study

Official title: 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.

Read the 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.

Being tested
Antiinflammatory Diet, Control Diet
Keywords
Rheumatoid Arthritis, Diet, Antiinflammatory diet, Nutrition
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT05254223
Study groupRoleWhat they receive
Control Diet (NDA)ExperimentalNo dietary advice (NDA)
Receives: Other: Control Diet
Anti-inflammatory Diet (AIDA)ExperimentalAnti-inflammatory Dietary advice (AIDA)
Receives: Other: Antiinflammatory Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in disease activity

    Disease activity is determined by Simplified Disease Activity Index (SDAI)

    Measured: Day 0, month 4, month 8 and month12.

  2. Changes in disease activity

    Disease activity is determined by DAS28 score_ c reactive protein (DAS28-CRP)

    Measured: Day 0, month 4, month 8 and month12.

  3. Changes in disease activity

    Disease activity is determined by DAS28 score_ erythrocyte sedimentation rate (DAS28-ESR)

    Measured: Day 0, month 4, month 8 and month12.

  4. Changes in disease activity

    Disease activity is determined by Clinical Disease Activity Index (CDAI)

    Measured: Day 0, month 4, month 8 and month12.

  5. Changes in functional capacity

    Functional capacity is assessed by the Health Assessment Questionnaire (HAQ).

    Measured: Day 0, month 4, month 8 and month12.

  6. Changes in self-perceived health

    Self-perceived health is evaluated by questionnaire EuroQol-5D-3L (EQ-5D)

    Measured: Day 0, month 4, month 8 and month12.

  7. 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)

    Measured: Month 12.

  8. 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).

    Measured: Day 0, month 4, month 8 and month12.

  9. 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.

    Measured: Day 0, month 4, month 8 and month12.

  10. Changes in Dietary inflammatory Index (DII)

    Dietary inflammatory index are calculated with the information provides by 24 hour dietary recall 3 days/week.

    Measured: Day 0, month 4, month 8 and month12.

Secondary outcomes (8)

  1. 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.

    Measured: Every week from day 0 and during 12 months.

  2. 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.

    Measured: Every week from day 0 and during 12 months.

  3. 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.

    Measured: Every week from day 0 and during 12 months.

  4. 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.

    Measured: Day 0, month 4, month 8 and month12.

  5. 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.

    Measured: Day 0, month 4, month 8 and month12.

  6. Changes in anthropometric mesurements

    Participant's height (m) and weight (Kg) will be measured and body mass index (BMI) will be calculated.

    Measured: Day 0, month 4, month 8 and month12.

  7. Changes in anthropometric measurements

    Body fat percentage (BFP) analyzed by bioelectrical impedance analysis (BIA).

    Measured: Day 0, month 4, month 8 and month12.

  8. 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

    Measured: Day 0, month 4, month 8 and month12.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2022
  2. Study start12 Dec 2016
  3. Primary completion19 Oct 2017
  4. Study completion19 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05254223
Sponsor's protocol ID
NSP-2016-1
Acronym
AIDE-RAP
Status last verified
Feb 2022
First submitted
13 Jan 2022
Last updated
24 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

  • 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.

    PubMed 8286893

  • 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.

    PubMed 18791055

Questions about this trial

What is this clinical trial studying?

A study testing Antiinflammatory Diet in people with Rheumatoid Arthritis, run by Jose manuel Lou Bonafonte.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in disease activity (time frame: Day 0, month 4, month 8 and month12.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05254223, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.

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