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The Effect of an Anti-inflammatory Diet in Patients With Rheumatoid Arthritis (DAIAR)

19. april 2022 opdateret af: Universidade Nova de Lisboa

The Effect of an Anti-inflammatory Diet on Disease Activity and Quality of Life in Patients With Rheumatoid Arthritis - Parallel Controlled Randomized Clinical Trial

Rheumatoid arthritis (RA) is an autoimmune disease that affects 0.5-1% of the population and in which his remission is not always achieved, affecting physical and mental well-being and quality of life (QL). As a complement to pharmacotherapy, dietary intervention should be evaluated as a treatment option.

The main objective of this parallel controlled randomized clinical trial is to check the effect of an anti-inflammatory dietary intervention, compared to a diet based on the principles of the Mediterranean diet (control), on disease activity (AD) and improving QL.

Patients will be instructed to follow an anti-inflammatory diet (DAI) or a control diet (DC) for 6 months. The AD and QL will be evaluated at the end of the intervention.

As there are no dietary guidelines for RA, this study aims to provide scientific evidence about the impact of diet therapy on reducing AD and improving QL.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The main objective of this trial is to check the effect of an DAI, compared to a DC, on reducing AD and improving QL.

As secondary objectives, it is intended to investigate the relationship of DAI with inflammatory markers and with the modulation of the composition / diversity of the intestinal microbiota, in comparison with a DC.

This study combines all dietary components with an anti-inflammatory effect, thus allowing the possibility of evaluating the full potential of dietary treatment in the disease, including intestinal microbiota modulation.

These results are intended to further contribute to clinical decision making and better evidence-based treatment.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

26

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Portugal
      • Portimão, Portugal
        • Hospital Particular do Algarve - HPA Saúde

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age over 18 years;
  • Presence of active disease, (DAS28≥ 2.6), under adequate control and medication.
  • Able to sign informed consent

Exclusion Criteria:

  • Any type of psychological deficiency, dementia or eating disorder;
  • Presence of food allergies and / or intolerances;
  • Be vegetarian or use Phytotherapy or other supplements (namely, pre and probiotics);
  • Use of antibiotics im the last 6 months;
  • Have had previous nutritional monitoring or change in eating habits in the last 6 months.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Diet Control
Diet Control (DC): nutritional education and adherence monitoring. DC will be based on the Portuguese "Nova Roda dos Alimentos" following the principles of the Mediterranean diet.
Andet: Diet Control
Diet following mediterranean principles, for 15 weeks
Eksperimentel: Diet Anti-inflammatory
Diet Anti-inflammatory (DAI): nutritional education and adherence monitoring. The DAI dietary intervention will be based on combining individual food items described as potential anti-inflammatory mitigators.
Andet: Diet anti-inflammatory
Diet combining food items with anti-inflammatory potential, following the principles described in Rondanelli, Clinical Nutrition, 2021 Mar;40(3):661-689. doi: 10.1016/j.clnu.2020.08.020.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in disease activity
Tidsramme: 15 weeks
Difference between the intervention and control group in the changes in Disease Activity (using DAS28 score: greater than 2,6 implies active disease), from baseline to the end of follow-up
15 weeks
Changes in Quality of Life
Tidsramme: 15 weeks
Difference between the intervention and control group in changes in Quality of Life (Health Assessment Questionnaire (HAQ): scores of 0 to 1 are generally considered to represent mild to moderate difficulty, 1 to 2 moderate to severe disability, and 2 to 3 severe to very severe disability), from baseline to the end of follow-up
15 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in C-Reactive Protein (CRP)
Tidsramme: 15 weeks
Difference between the intervention and control group in changes in C-Reactive Protein (CRP) measured in mg/L, from baseline to the end of follow-up
15 weeks
Changes in Erythrocyte Sedimentation Rate (ESR)
Tidsramme: 15 weeks
Difference between the intervention and control group in changes in Erythrocyte Sedimentation Rate (ESR) measured in mm/h, from baseline to the end of follow-up
15 weeks
Changes in Rheumatoid Factor (RF)
Tidsramme: 15 weeks
Difference between the intervention and control group changes in Rheumatoid Factor (RF) measured in IU/mL, from baseline to the end of follow-up
15 weeks
Changes in Gut microbiota
Tidsramme: 15 weeks

Difference between the intervention and control group in the change of gut microbiota from baseline to the end of follow-up.

Bacterial DNA will be extracted from fecal samples. 16SRNA gene will be sequenced by next-generation sequencing (NGS). All the identified bacterial phyla, genus and species will be expressed in percentage.
15 weeks
Changes in weight
Tidsramme: 15 weeks
Difference between the intervention and control group changes in weight, measured in Kg, from baseline to the end of follow-up
15 weeks
Changes in Body Mass Index (BMI)
Tidsramme: 15 weeks
Difference between the intervention and control group changes in BMI, calculated using weight and height, presented in kg/m2: underweight < 18,5; normoweight 18,6-24,9; overweight 25-29,9; obese >30, from baseline to the end of follow-up
15 weeks
Changes in waist circumference perimeter
Tidsramme: 15 weeks
Difference between the intervention and control group changes in waist circumference perimeter, measured in cm, from baseline to the end of follow-up
15 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universidade Nova de Lisboa

Samarbejdspartnere

Hospital Particular do Algarve - HPA Saúde

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. april 2021

Primær færdiggørelse (Faktiske)

20. december 2021

Studieafslutning (Faktiske)

20. december 2021

Datoer for studieregistrering

Først indsendt

25. marts 2022

Først indsendt, der opfyldte QC-kriterier

19. april 2022

Først opslået (Faktiske)

20. april 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. april 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. april 2022

Sidst verificeret

1. april 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DAIAR

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Rheumatoid arthritis

Kliniske forsøg med Diet Control

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