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

December 1, 2014 updated by: Elena Pita Calandre, Universidad de Granada

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Granada, Spain, 18012
        • Instituto de Neurociencias "Federico Oloriz"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gluten-free diet
Other: Gluten-free diet
A diet that is free of the gluten component
Active Comparator: Hypocaloric diet
Other: Hypocaloric diet
A standard hypocaloric diet with a daily 1500 caloric intake.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change, between baseline and endpoint, in the number of experienced celiac-type symptoms
Time Frame: 0, 4, 8, 12, 18 and 24 weeks
0, 4, 8, 12, 18 and 24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Granada

Investigators

  • Principal Investigator: Elena P. Calandre, M.D., Universidad de Granada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

June 17, 2013

First Submitted That Met QC Criteria

June 18, 2013

First Posted (Estimate)

June 19, 2013

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMS-GFD-013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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