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Anti-inflammatory Nutritional Intervention in Patients With Fibromyalgia

NCT04007705 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2021-11-15

No results posted yet for this study

Summary

This is a randomized clinical trial, aimed to analyse the effects of a potentially anti-inflammatory nutritional intervention in disease assessment parameters, inflammatory markers, and quality of life of Fibromyalgia patients. Patients in the intervention group will adopt an anti-inflammatory diet and a diet with a low ingestion of fermentable oligo-, di- and monosaccharides, and polyols (FODMAPs), for a 3 months period. Group control will adopt a diet based on general recommendations for healthy eating in accordance with the World Health Organization.

Conditions

  • Fibromyalgia

Interventions

BEHAVIORAL

Anti-inflammatory and low FODMAPs diet

Exemption of the intake of potentially inflammatory foods, namely gluten, dairy and processed foods, over a consecutive period of 3 months. During the first month, a low FODMAPs diet will be implemented, along with the anti-inflammatory diet, followed by the reintroduction of all fruits and vegetables over a consecutive period of 2 months.

BEHAVIORAL

General healthy eating

Healthy eating counseling according to the World Health Organization

Sponsors & Collaborators

  • Portuguese Institute of Rheumatology

    collaborator UNKNOWN

  • Centro de Investigação Interdisciplinar Egas Moniz

    collaborator UNKNOWN

  • Universidade do Porto

    lead OTHER

Principal Investigators

  • Ana Rita Silva, MD · Universidade do Porto

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-09
Primary Completion
2020-06-04
Completion
2020-06-04

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04007705 on ClinicalTrials.gov