Clinical Trials Detalhe
Anti-inflammatory Nutritional Intervention in Patients With Fibromyalgia
General Information
Gender
FEMALE
Age
from 18 Years to 75 Years
Phase
NA
Study Type
INTERVENTIONAL
Location
Instituto Português de Reumatologia (Lisbon, Portugal)
Clinicaltrial.gov
https://classic.clinicaltrials.gov/ct2/show/NCT04007705Summary
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
Eligibility
Inclusion Criteria: * Diagnosis of FM performed by the physician, according to the Rome III criteria of the American College of Rheumatology, revised in 2010; * Ability to read and sign the Informed Consent; * Stable dose therapy within 4 weeks before study start. Exclusion Criteria: * Patients with pathologies that prevent the follow-up of the given dietary protocol; * Patients currently undergoing lactation or pregnancy; * Prior or current clinical history of abuse of drug or other substances; * Change of therapy during the intervention period; * Presence of other inflammatory diseases; * Uncontrolled medical conditions (eg. Diabetes Mellitus, decompensated heart disease, renal failure, neoplastic diseases, liver diseases).