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

datacite.subject.fosCiências Médicas
datacite.subject.sdg03:Saúde de Qualidade
dc.contributor.authorSilva, Ana Rita
dc.contributor.authorBernardo, Alexandra
dc.contributor.authorMesquita, Maria Fernanda de
dc.contributor.authorPatto, José Vaz
dc.contributor.authorMoreira, Pedro
dc.contributor.authorSilva, Maria Leonor
dc.contributor.authorPadrão, Patrícia
dc.date.accessioned2025-09-08T11:10:18Z
dc.date.available2025-09-08T11:10:18Z
dc.date.issued2021-03
dc.description.abstractBackground: This 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. Methods: A 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 3 months. 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 2 months. 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 3 months intervention, and also 1 month 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. Discussion: The results of this study are expected to determine whether a change in patient nutrition helps to alleviate symptoms, which would optimize medical intervention.eng
dc.identifier.citationSilva, A.R., Bernardo, A., de Mesquita, M.F. et al. A study protocol for a randomized controlled trial of an anti-inflammatory nutritional intervention in patients with fibromyalgia. Trials 22, 198 (2021). https://doi.org/10.1186/s13063-021-05146-3
dc.identifier.doi10.1186/s13063-021-05146-3
dc.identifier.issn1745-6215
dc.identifier.urihttp://hdl.handle.net/10400.26/58601
dc.language.isoeng
dc.peerreviewedyes
dc.publisherBMC
dc.relation.hasversionhttps://doi.org/10.1186/s13063-021-05146-3
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectFibromyalgia
dc.subjectDiet
dc.subjectAnti-inflammatory
dc.subjectFODMAPs
dc.subjectPain
dc.subjectQuality of life
dc.subjectRandomized controlled trial
dc.titleA study protocol for a randomized controlled trial of an anti-inflammatory nutritional intervention in patients with fibromyalgiaeng
dc.typecontribution to journal
dspace.entity.typePublication
oaire.citation.issue1
oaire.citation.startPage198
oaire.citation.titleTrials
oaire.citation.volume22
oaire.versionhttp://purl.org/coar/version/c_970fb48d4fbd8a85

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