Efficacy of a Gluten-free Diet for the Treatment of Fibromyalgia

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Other: Gluten-free diet; Other: Hypocaloric diet

• Registration Number: NCT01881360
• Lead Sponsor: Universidad de Granada

Brief Summary

Fibromyalgia patients frequently suffer from symptoms similar to those of adult celiac disease, raising the possibility that some fibromyalgia patients experience oligosymptomatic celiac disease or non-celiac gluten intolerance. The objective of this study is to compare the effect of a gluten-free diet with a hypocaloric diet in patients with fibromyalgia and celiac-type symptoms.

Detailed Description

Fibromyalgia, a chronic pain disorder, is characterized by generalized chronic musculoskeletal pain that is usually accompanied by several other clinical manifestations that contribute to a diminished quality of life, such as sleep disturbances, chronic fatigue, mood disorders, and cognitive difficulties. Many patients with fibromyalgia suffer from gastrointestinal and extra-intestinal symptoms that are similar to those experienced by adult celiac disease patients such as abdominal pain, dyspepsia, nausea, diarrhea, constipation, fatigue, pain and mood changes. This raises the possibility that some patients with fibromyalgia may also suffer from oligosymptomatic celiac disease or non-celiac gluten intolerance. On the other hand, the emerging evidence linking obesity with fibromyalgia and the high prevalence of overweight among fibromyalgia patients suggest a potential benefit for weight loss among these patients. Thus, the main objective of this study is to compare the efficacy of a gluten-free diet (GFD) with a hypocaloric diet (HCD) in patients with fibromyalgia that also experience celiac-type symptoms.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-06-17
• Study First Submitted QC: 2013-06-18
• Study First Posted: 2013-06-19
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• Adult patients diagnosed with fibromyalgia according to the 1990 American College of Rheumatology diagnostic criteria.
• Patients who successfully complete the screening process for sufficient celiac-type symptoms
• Negative transglutaminase antibodies serological testing.
• Signed informed consent to participate

Exclusion Criteria

• Patients suffering from any disease that could prevent them from following any of the suggested diet protocols
• Current or previous history of substance abuse
• Pregnancy and lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gluten-free diet	Gluten-free diet	-
Hypocaloric diet	Hypocaloric diet	-

Primary Outcome Measures

Name	Time	Method
Change, between baseline and endpoint, in the number of experienced celiac-type symptoms	0, 4, 8, 12, 18 and 24 weeks

Secondary Outcome Measures

Name	Time	Method
Change, between baseline and endpoint, in the Body Mass Index	0, 4, 8, 12, 18 and 24 weeks
Change, between baseline and endpoint, in the Revised Fibromyalgia Impact Questionnaire total score	0, 4, 8, 12, 18 and 24 weeks
Change, between baseline and endpoint, in the Pittsburgh Sleep Quality Index	0, 4, 8, 12, 18 and 24 weeks
Change, between baseline and endpoint, in the Brief Pain Inventory	0, 4, 8, 12, 18 and 24 weeks
Change, between baseline and endpoint, in the Beck Depression Inventory	0, 4, 8, 12, 18 and 24 weeks
Change, between baseline and endpoint, in the Short-form Health Survey	0, 4, 8, 12, 18 and 24 weeks
Change, between baseline and endpoint, in the State-Trait Anxiety Inventory	0, 4, 8, 12, 18, 24 weeks

Trial Locations

Locations (1)

Instituto de Neurociencias "Federico Oloriz"; 🇪🇸 Granada, Spain