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Effects of an Anti-inflammatory Nutritional Intervention in Disease Assessment Parameters, Inflammatory Markers, and Quality of Life of Patients With Fibromyalgia

ClinicalTrials.gov · COMPLETED, 2020

46 participants

Abstract

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.

Primary outcome: Change in pain, accessed by Visual Analogue Pain Scale; Change in pain, accessed by Brief Pain Inventory; Change in quality of life accessed by Revised Fibromyalgia Impact Questionnaire; Change in quality of life accessed by Short-form 36; Change in inflammatory parameters accessed by serum C-reactive protein measurement; Change in inflammatory parameters accessed by serum erythrocyte sedimentation rate measurement; Change in inflammatory parameters accessed by serum interleukin-8 measurement.

Enrollment: 46 participants.

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 46 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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