Back to resultsEfficacy of a Gluten-free Diet for the Treatment of Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Gluten-free diet
Hypocaloric diet
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring fibromyalgia, celiac-type symptoms, gluten-free diet, hypocaloric diet
Eligibility 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
Sites / Locations
- Instituto de Neurociencias "Federico Oloriz"
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Gluten-free diet
Hypocaloric diet
Arm Description
Outcomes
Primary Outcome Measures
Change, between baseline and endpoint, in the number of experienced celiac-type symptoms
Secondary Outcome Measures
Change, between baseline and endpoint, in the Body Mass Index
Change, between baseline and endpoint, in the Revised Fibromyalgia Impact Questionnaire total score
Change, between baseline and endpoint, in the Pittsburgh Sleep Quality Index
Change, between baseline and endpoint, in the Brief Pain Inventory
Change, between baseline and endpoint, in the Beck Depression Inventory
Change, between baseline and endpoint, in the Short-form Health Survey
Change, between baseline and endpoint, in the State-Trait Anxiety Inventory
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01881360
Brief Title
Efficacy of a Gluten-free Diet for the Treatment of Fibromyalgia
Official Title
Comparison Between a Gluten-free Diet and a Hypocaloric Diet for the Treatment of Patients With Fibromyalgia and Celiac-type Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
fibromyalgia, celiac-type symptoms, gluten-free diet, hypocaloric diet
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gluten-free diet
Arm Type
Experimental
Arm Title
Hypocaloric diet
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Gluten-free diet
Intervention Description
A diet that is free of the gluten component
Intervention Type
Other
Intervention Name(s)
Hypocaloric diet
Intervention Description
A standard hypocaloric diet with a daily 1500 caloric intake.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Change, between baseline and endpoint, in the Body Mass Index
Time Frame
0, 4, 8, 12, 18 and 24 weeks
Title
Change, between baseline and endpoint, in the Revised Fibromyalgia Impact Questionnaire total score
Time Frame
0, 4, 8, 12, 18 and 24 weeks
Title
Change, between baseline and endpoint, in the Pittsburgh Sleep Quality Index
Time Frame
0, 4, 8, 12, 18 and 24 weeks
Title
Change, between baseline and endpoint, in the Brief Pain Inventory
Time Frame
0, 4, 8, 12, 18 and 24 weeks
Title
Change, between baseline and endpoint, in the Beck Depression Inventory
Time Frame
0, 4, 8, 12, 18 and 24 weeks
Title
Change, between baseline and endpoint, in the Short-form Health Survey
Time Frame
0, 4, 8, 12, 18 and 24 weeks
Title
Change, between baseline and endpoint, in the State-Trait Anxiety Inventory
Time Frame
0, 4, 8, 12, 18, 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena P. Calandre, M.D.
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Neurociencias "Federico Oloriz"
City
Granada
ZIP/Postal Code
18012
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Efficacy of a Gluten-free Diet for the Treatment of Fibromyalgia
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