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Completed

NCT Number: NCT01881360

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Neurociencias "Federico Oloriz"

Granada, 18012, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gluten-free diet

Other

A diet that is free of the gluten component

Hypocaloric diet

Other

A standard hypocaloric diet with a daily 1500 caloric intake.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 19, 2013
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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