NCT04007705

Anti-inflammatory Nutritional Intervention in Patients With Fibromyalgia

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Universidade do Porto · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
BEHAVIORAL	Anti-inflammatory and low FODMAPs diet	Exemption of the intake of potentially inflammatory foods, namely gluten, dairy and 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.
BEHAVIORAL	General healthy eating	Healthy eating counseling according to the World Health Organization

Timeline

• Start date: 2019-04-09
• Primary completion: 2020-06-04
• Completion: 2020-06-04
• First posted: 2019-07-05
• Last updated: 2021-11-15

Locations

1 site across 1 country: Portugal