Clinical trial NCT04007705: Anti-inflammatory Nutritional Intervention in Patients With Fibromyalgia
Official title: Effects of an Anti-inflammatory Nutritional Intervention in Disease Assessment Parameters, Inflammatory Markers, and Quality of Life of Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Antiinflammatory diet
Low FODMAPs diet
Gluten, casein, sugar and processed-foods free diet
Nutrition
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Portuguese Institute of Rheumatology
name: Centro de Investigação Interdisciplinar Egas Moniz
First posted: 2019-07-05
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: The presence of low grade intestinal inflammation has been reported in Fibromyalgia (FM) patients. Other studies associate the persistence of symptoms described in FM to possible alterations of the intestinal microbiota composition, i.e. dysbiosis, with consequent existence of Small Intestinal Bacterial Overgrowth (SIBO). A sample of 100 female patients diagnosed with FM, followed-up at Portuguese Rheumathology Institute in Lisbon, will be distributed randomly in two groups. Group 1 will adopt an anti-inflammatory diet, which is characterized by the exemption of the intake of potentially inflammatory foods, namely gluten, dairy and ultra-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, for a total of 3 months of intervention. Group 2 will adopt a diet based on general recommendations for healthy eating in accordance with the World Health Organization. The Ethics Committee of the Portuguese Institute of Rheumathology approved this intervention study.

The results of this study are expected to determine whether a change in patient nutrition helps to alleviate symptoms, which would optimize medical intervention.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in pain, accessed by Visual Analogue Pain Scale
timeFrame: 1 and 3 months after baseline
measure: Change in pain, accessed by Brief Pain Inventory
timeFrame: 1 and 3 months after baseline
measure: Change in quality of life accessed by Revised Fibromyalgia Impact Questionnaire
timeFrame: 1 and 3 months after baseline
measure: Change in quality of life accessed by Short-form 36
timeFrame: 1 and 3 months after baseline
measure: Change in inflammatory parameters accessed by serum C-reactive protein measurement
timeFrame: 3 months after baseline
measure: Change in inflammatory parameters accessed by serum erythrocyte sedimentation rate measurement
timeFrame: 3 months after baseline
measure: Change in inflammatory parameters accessed by serum interleukin-8 measurement
timeFrame: 3 months after baseline
Secondary outcomes:
measure: Change in fatigue accessed by Fatigue Severity Survey
timeFrame: 1 and 3 months after baseline
measure: Change in gastrointestinal symptoms accessed by Visual Analog Scale from a list of common gastrointestinal symptoms
timeFrame: 1 and 3 months after baseline
measure: Change in quality of sleep accessed by Pittsburgh Sleep Quality Index
timeFrame: 1 and 3 months after baseline
measure: Change in weight
timeFrame: 3 months after baseline
measure: Change in waist circumference
timeFrame: 3 months after baseline
measure: Change in body fat mass
timeFrame: 3 months after baseline
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Instituto Português de Reumatologia
Study officials:
affiliation: Universidade do Porto
name: Ana Rita Silva, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Uceyler N, Hauser W, Sommer C. Systematic review with meta-analysis: cytokines in fibromyalgia syndrome. BMC Musculoskelet Disord. 2011 Oct 28;12:245. doi: 10.1186/1471-2474-12-245.
citation: Silva AR, Bernardo A, Costa J, Cardoso A, Santos P, de Mesquita MF, Vaz Patto J, Moreira P, Silva ML, Padrao P. Dietary interventions in fibromyalgia: a systematic review. Ann Med. 2019;51(sup1):2-14. doi: 10.1080/07853890.2018.1564360.
citation: Statovci D, Aguilera M, MacSharry J, Melgar S. The Impact of Western Diet and Nutrients on the Microbiota and Immune Response at Mucosal Interfaces. Front Immunol. 2017 Jul 28;8:838. doi: 10.3389/fimmu.2017.00838. eCollection 2017.
citation: Shivappa N, Steck SE, Hurley TG, Hussey JR, Hebert JR. Designing and developing a literature-derived, population-based dietary inflammatory index. Public Health Nutr. 2014 Aug;17(8):1689-96. doi: 10.1017/S1368980013002115. Epub 2013 Aug 14.
citation: Silva AR, Bernardo A, de Mesquita MF, Vaz-Patto J, Moreira P, Silva ML, Padrao P. An anti-inflammatory and low fermentable oligo, di, and monosaccharides and polyols diet improved patient reported outcomes in fibromyalgia: A randomized controlled trial. Front Nutr. 2022 Aug 15;9:856216. doi: 10.3389/fnut.2022.856216. eCollection 2022.
citation: Silva AR, Bernardo A, de Mesquita MF, Vaz Patto J, Moreira P, Silva ML, Padrao P. A study protocol for a randomized controlled trial of an anti-inflammatory nutritional intervention in patients with fibromyalgia. Trials. 2021 Mar 9;22(1):198. doi: 10.1186/s13063-021-05146-3.