Anti-inflammatory Nutritional Intervention in Patients With Fibromyalgia

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04007705
Study type	Interventional
Source	Universidade do Porto
Contact
Status	Completed
Phase	N/A
Start date	April 9, 2019
Completion date	June 4, 2020

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05659862` - Digitally Assisted Behavioral Physical Activity Intervention in Fibromyalgia	N/A
Recruiting	`NCT03207828` - Testing Interventions for Patients With Fibromyalgia and Depression	N/A
Completed	`NCT03042728` - Impact of Inclusion of a Therapy Dog Visit as Part of the Fibromyalgia Treatment Program	N/A
Recruiting	`NCT06097091` - Effects and Mechanisms of Pain Neuroscience Education in Patients With Fibromyalgia	N/A
Recruiting	`NCT04554784` - Effectiveness of Bowen Therapy for Pain Management in Patients With Fibromyalgia	N/A
Completed	`NCT03300635` - Metabolism, Muscle Function and Psychological Factors in Fibromyalgia	N/A
Recruiting	`NCT06166563` - Exercise, Irritable Bowel Syndrome and Fibromyalgia	N/A
Completed	`NCT03166995` - Postural Exercises in Women With Fibromyalgia	N/A
Completed	`NCT03227952` - Sensory Stimulation in Fibromyalgia	N/A
Recruiting	`NCT06237595` - Vagus Nerve Stimulation in Fibromyalgia	N/A
Completed	`NCT01888640` - Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST)	N/A
Completed	`NCT03641495` - Pain Education and Therapeutic Exercise for Fibromyalgia	N/A
Recruiting	`NCT05581628` - FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
Active, not recruiting	`NCT05128162` - Open-label Study to Assess the Safety and Efficacy of Psilocybin With Psychotherapy in Adult Participants With Fibromyalgia	Phase 2
Completed	`NCT04674878` - Comparison of Muscle Energy Techniques and Breathing Exercises for Functional Improvement in Fibromyalgia	N/A
Active, not recruiting	`NCT04084795` - Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia	N/A
Completed	`NCT03129906` - Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients	N/A
Completed	`NCT05058911` - Exposure-based Cognitive Behavior Therapy vs Traditional Cognitive Behavior Therapy for Fibromyalgia	N/A
Recruiting	`NCT04571528` - Effectiveness of VIRTUAL FIBROWALK STUDY	N/A
Recruiting	`NCT04571853` - New Educational Tool for FM	N/A