A study protocol for a randomized controlled trial of an anti-inflammatory nutritional intervention in patients with fibromyalgia

• Type: Article in International Scientific Journal
• Date: 2021

Authors

Silva, AR (Author) Other; Bernardo, A (Author) Other; de Mesquita, MF (Author) Other; Patto, JV (Author) Other; Moreira, Pedro (Author) FCNAUP; Silva, ML (Author) Other; Padrão, Patrícia (Author) FCNAUP

Journal

Title: Trials

Vol. 22

ISSN: 1745-6215

Publisher: Springer Nature

Indexing

ISI Web of Knowledge - 2 Citations

Scopus - 1 Citation

Scientific classification

CORDIS: Health sciences

FOS: Medical and Health sciences

Other information

Authenticus ID: P-00T-N1Q

DOI: 10.1186/s13063-021-05146-3

Abstract (EN): BackgroundThis study aims to analyze the effects of a potentially anti-inflammatory nutritional intervention in disease assessment parameters, inflammatory markers, and quality of life of fibromyalgia (FM) patients.MethodsA sample of 100 female patients diagnosed with FM, followed up at Portuguese Institute of Rheumatology (IPR) in Lisbon, is being randomly allocated in two groups. Patients in the intervention group are adopting an anti-inflammatory diet, characterized by the exemption of the intake of foods containing gluten, dairy, sugar, and ultra-processed foods, during 3months. During the first month, a low fermentable oligo-, di-, and monosaccharides and polyols (FODMAPs) diet is implemented, along with the anti-inflammatory diet, followed by the reintroduction of all fruits and vegetables over a consecutive period of 2months. Patients in the control group are adopting a diet based on general recommendations for healthy eating. The outcomes are pain, fatigue, quality of sleep, quality of life, gastrointestinal symptoms, and inflammation. Before and after the 3months intervention, and also 1month after beginning the intervention, the following questionnaires are applied: Revised Fibromyalgia Impact Questionnaire, visual analog pain scale, Brief Pain Inventory,visual analog scale from a list of common gastrointestinal and extraintestinal symptoms in FM, Short Form 36, Fatigue Severity Survey, and Pittsburg Sleep Quality Index. Ultra-sensitive serum C-reactive protein, eritrocyte sedimentation rate, and interleukin-8 are determined. Age, physical activity, anthropometric parameters, and body composition are being collected. Student's t test will assess the association between the disease evaluation parameters, the inflammatory markers, and the dietary interventions.DiscussionThe results of this study are expected to determine whether a change in patient nutrition helps to alleviate symptoms, which would optimize medical intervention.Trial registrationwww.ClinicalTrials.gov NCT04007705. Registered on July 5, 2019.

Language: English

Type (Professor's evaluation): Scientific

No. of pages: 9