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

Fibromyalgia Clinical Trial

Official title:

Comparison Between a Gluten-free Diet and a Hypocaloric Diet for the Treatment of Patients With Fibromyalgia and Celiac-type Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01881360
• Other study ID #: FMS-GFD-013
• Status: Completed
• Phase: N/A
• First received: June 17, 2013
• Last updated: December 1, 2014
• Start date: January 2013
• Est. completion date: October 2014

Study information

• Verified date: December 2014
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• Gluten-free diet
A diet that is free of the gluten component
• Hypocaloric diet
A standard hypocaloric diet with a daily 1500 caloric intake.

Locations

Country	Name	City	State
Spain	Instituto de Neurociencias "Federico Oloriz"	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change, between baseline and endpoint, in the number of experienced celiac-type symptoms		0, 4, 8, 12, 18 and 24 weeks	No
Secondary	Change, between baseline and endpoint, in the Body Mass Index		0, 4, 8, 12, 18 and 24 weeks	No
Secondary	Change, between baseline and endpoint, in the Revised Fibromyalgia Impact Questionnaire total score		0, 4, 8, 12, 18 and 24 weeks	No
Secondary	Change, between baseline and endpoint, in the Pittsburgh Sleep Quality Index		0, 4, 8, 12, 18 and 24 weeks	No
Secondary	Change, between baseline and endpoint, in the Brief Pain Inventory		0, 4, 8, 12, 18 and 24 weeks	No
Secondary	Change, between baseline and endpoint, in the Beck Depression Inventory		0, 4, 8, 12, 18 and 24 weeks	No
Secondary	Change, between baseline and endpoint, in the Short-form Health Survey		0, 4, 8, 12, 18 and 24 weeks	No
Secondary	Change, between baseline and endpoint, in the State-Trait Anxiety Inventory		0, 4, 8, 12, 18, 24 weeks	No