Clinical trial NCT01881360: 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
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: fibromyalgia
celiac-type symptoms
gluten-free diet
hypocaloric diet
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2013-06-19
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change, between baseline and endpoint, in the number of experienced celiac-type symptoms
timeFrame: 0, 4, 8, 12, 18 and 24 weeks
Secondary outcomes:
measure: Change, between baseline and endpoint, in the Body Mass Index
timeFrame: 0, 4, 8, 12, 18 and 24 weeks
measure: Change, between baseline and endpoint, in the Revised Fibromyalgia Impact Questionnaire total score
timeFrame: 0, 4, 8, 12, 18 and 24 weeks
measure: Change, between baseline and endpoint, in the Pittsburgh Sleep Quality Index
timeFrame: 0, 4, 8, 12, 18 and 24 weeks
measure: Change, between baseline and endpoint, in the Brief Pain Inventory
timeFrame: 0, 4, 8, 12, 18 and 24 weeks
measure: Change, between baseline and endpoint, in the Beck Depression Inventory
timeFrame: 0, 4, 8, 12, 18 and 24 weeks
measure: Change, between baseline and endpoint, in the Short-form Health Survey
timeFrame: 0, 4, 8, 12, 18 and 24 weeks
measure: Change, between baseline and endpoint, in the State-Trait Anxiety Inventory
timeFrame: 0, 4, 8, 12, 18, 24 weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Instituto de Neurociencias "Federico Oloriz"
Study officials:
affiliation: Universidad de Granada
name: Elena P. Calandre, M.D.
role: PRINCIPAL_INVESTIGATOR
References: