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

NCT01881360 | Completed

• 1 other identifier: FMS-GFD-013
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

fibromyalgia; celiac-type symptoms; gluten-free diet; hypocaloric diet

Outcome Measures

Primary Outcomes (1)

• Change, between baseline and endpoint, in the number of experienced celiac-type symptoms

  0, 4, 8, 12, 18 and 24 weeks

Secondary Outcomes (7)

• Change, between baseline and endpoint, in the Body Mass Index

  0, 4, 8, 12, 18 and 24 weeks

• Change, between baseline and endpoint, in the Revised Fibromyalgia Impact Questionnaire total score

  0, 4, 8, 12, 18 and 24 weeks

• Change, between baseline and endpoint, in the Pittsburgh Sleep Quality Index

  0, 4, 8, 12, 18 and 24 weeks

• Change, between baseline and endpoint, in the Brief Pain Inventory

  0, 4, 8, 12, 18 and 24 weeks

• Change, between baseline and endpoint, in the Beck Depression Inventory

  0, 4, 8, 12, 18 and 24 weeks

Study Arms (2)

Gluten-free diet

EXPERIMENTAL

Other: Gluten-free diet

Hypocaloric diet

ACTIVE COMPARATOR

Other: Hypocaloric diet

Interventions

Gluten-free diet OTHER

A diet that is free of the gluten component

Gluten-free diet

Hypocaloric diet OTHER

A standard hypocaloric diet with a daily 1500 caloric intake.

Hypocaloric diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Instituto de Neurociencias "Federico Oloriz"

Granada, Granada, 18012, Spain

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Diet, Gluten-Free

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Elena P. Calandre, M.D.

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Responsible of the CTS-502 Investigation Team

Study Record Dates

• First Submitted: June 17, 2013
• First Posted: June 19, 2013
• Study Start: January 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

ES (1)