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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Universidad de Granada
Sponsor:
Information provided by (Responsible Party):
Elena Pita Calandre, Universidad de Granada
ClinicalTrials.gov Identifier:
NCT01881360
First received: June 17, 2013
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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 Intervention
Fibromyalgia
Other: Gluten-free diet
Other: Hypocaloric diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Universidad de Granada:

Primary Outcome Measures:
  • Change, between baseline and endpoint, in the number of experienced celiac-type symptoms [ Time Frame: 0, 4, 8, 12, 18 and 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change, between baseline and endpoint, in the Body Mass Index [ Time Frame: 0, 4, 8, 12, 18 and 24 weeks ] [ Designated as safety issue: No ]
  • Change, between baseline and endpoint, in the Revised Fibromyalgia Impact Questionnaire total score [ Time Frame: 0, 4, 8, 12, 18 and 24 weeks ] [ Designated as safety issue: No ]
  • Change, between baseline and endpoint, in the Pittsburgh Sleep Quality Index [ Time Frame: 0, 4, 8, 12, 18 and 24 weeks ] [ Designated as safety issue: No ]
  • Change, between baseline and endpoint, in the Brief Pain Inventory [ Time Frame: 0, 4, 8, 12, 18 and 24 weeks ] [ Designated as safety issue: No ]
  • Change, between baseline and endpoint, in the Beck Depression Inventory [ Time Frame: 0, 4, 8, 12, 18 and 24 weeks ] [ Designated as safety issue: No ]
  • Change, between baseline and endpoint, in the Short-form Health Survey [ Time Frame: 0, 4, 8, 12, 18 and 24 weeks ] [ Designated as safety issue: No ]
  • Change, between baseline and endpoint, in the State-Trait Anxiety Inventory [ Time Frame: 0, 4, 8, 12, 18, 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: January 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01881360

Contacts
Contact: Elena P. Calandre, M.D. +34 958244033 epita@ugr.es
Contact: Mahmoud Slim, Ph. D. + 34 958244033 mslim@ugr.es

Locations
Spain
Instituto de Neurociencias "Federico Oloriz" Recruiting
Granada, Spain, 18012
Contact: Elena P. Calandre, M.D.    +34 958244033    epita@ugr.es   
Contact: Mahmoud Slim, Ph. D.    +34 958244033    mslim@ugr.es   
Sub-Investigator: Juan M. Garcia-Leiva, Ph.D.         
Sub-Investigator: Rocio Molina-Barea, M.D.         
Sub-Investigator: Carmen M. Rodriguez-Lopez, M.D.         
Sub-Investigator: Piedad Morillas-Arques, M.D.         
Sub-Investigator: Francisco J. Amado, M.D.         
Sub-Investigator: Mahmoud Slim, Ph.D.         
Sponsors and Collaborators
Universidad de Granada
Investigators
Principal Investigator: Elena P. Calandre, M.D. Universidad de Granada
  More Information

No publications provided

Responsible Party: Elena Pita Calandre, Responsible of the CTS-502 Investigation Team, Universidad de Granada
ClinicalTrials.gov Identifier: NCT01881360     History of Changes
Other Study ID Numbers: FMS-GFD-013
Study First Received: June 17, 2013
Last Updated: June 18, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Universidad de Granada:
fibromyalgia
celiac-type symptoms
gluten-free diet
hypocaloric diet

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 18, 2014