Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01881360
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):
Elena Pita Calandre, Universidad de Granada

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Other: Gluten-free diet Other: Hypocaloric diet Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between a Gluten-free Diet and a Hypocaloric Diet for the Treatment of Patients With Fibromyalgia and Celiac-type Symptoms
Study Start Date : January 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change, between baseline and endpoint, in the number of experienced celiac-type symptoms [ Time Frame: 0, 4, 8, 12, 18 and 24 weeks ]

Secondary Outcome Measures :
  1. Change, between baseline and endpoint, in the Body Mass Index [ Time Frame: 0, 4, 8, 12, 18 and 24 weeks ]
  2. Change, between baseline and endpoint, in the Revised Fibromyalgia Impact Questionnaire total score [ Time Frame: 0, 4, 8, 12, 18 and 24 weeks ]
  3. Change, between baseline and endpoint, in the Pittsburgh Sleep Quality Index [ Time Frame: 0, 4, 8, 12, 18 and 24 weeks ]
  4. Change, between baseline and endpoint, in the Brief Pain Inventory [ Time Frame: 0, 4, 8, 12, 18 and 24 weeks ]
  5. Change, between baseline and endpoint, in the Beck Depression Inventory [ Time Frame: 0, 4, 8, 12, 18 and 24 weeks ]
  6. Change, between baseline and endpoint, in the Short-form Health Survey [ Time Frame: 0, 4, 8, 12, 18 and 24 weeks ]
  7. Change, between baseline and endpoint, in the State-Trait Anxiety Inventory [ Time Frame: 0, 4, 8, 12, 18, 24 weeks ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881360


Locations
Layout table for location information
Spain
Instituto de Neurociencias "Federico Oloriz"
Granada, Spain, 18012
Sponsors and Collaborators
Universidad de Granada
Investigators
Layout table for investigator information
Principal Investigator: Elena P. Calandre, M.D. Universidad de Granada
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Elena Pita Calandre, Responsible of the CTS-502 Investigation Team, Universidad de Granada
ClinicalTrials.gov Identifier: NCT01881360    
Other Study ID Numbers: FMS-GFD-013
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014
Keywords provided by Elena Pita Calandre, Universidad de Granada:
fibromyalgia
celiac-type symptoms
gluten-free diet
hypocaloric diet
Additional relevant MeSH terms:
Layout table for MeSH terms
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases