Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients

NCT03129906 | Completed DMC

• 1 other identifier: 48529415.8.0000.5149
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the impact of gluten-free diets on symptoms and inflammatory markers in individuals with previous diagnosis of fibromyalgia (FM), as well as to identify the presence of non-celiac gluten sensitivity (NCSG) in individuals with FM. Patients with FM diagnosis will be kept on a gluten-free diet for a 10 weeks. In the 7th week, they will receive placebo capsules for 7 days and after washout, capsules containing gluten for another 7 days. A questionnaire based on Salerno protocol will be applied to evaluate the presence of NCGS in the beginning, 8th week and 10 week.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; non-celiac gluten sensitivity

Outcome Measures

Primary Outcomes (1)

• Changes in fibromyalgia Symptoms by Salerno protocol

  Self report of symptoms intensity in the last week. Each item is scored 0 (no symptom) to 10 (very intense symptom).

  Baseline, 4th and 8th weeks, 10th week

Secondary Outcomes (7)

• Changes in body weight

  Baseline, 8th and 10th weeks

• Height

  baseline

• changes in BMI

  Baseline, 8th and 10th weeks

• Changes in IL-6 blood concentration

  Baseline, 8th and 10th weeks

• Changes in IL-10 blood concentration

  Baseline, 8th and 10th weeks

Study Arms (2)

Gluten

ACTIVE COMPARATOR

Capsules containing 8 g/day of gluten (6,3g of protein) were blindly administered for 7 days

Dietary Supplement: Gluten

Rice protein

PLACEBO COMPARATOR

Capsules containing 6,4 g/day of rice protein were blindly administered for 7 days

Dietary Supplement: Rice protein

Interventions

Gluten DIETARY_SUPPLEMENT

Gluten

Rice protein DIETARY_SUPPLEMENT

Rice protein

Eligibility Criteria

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

You may qualify if:

• Women between 18 and 65 years of age with prior clinical diagnosis of FM, according to the American College of Rheumatology criteria of 2010

You may not qualify if:

• Subjects diagnosed with positive serology for celiac disease or allergy to wheat
• Subjects diagnosed with autoimmune diseases
• Subjects with diseases that are not part of the comorbidities associated with FM and t hat could influence the results of the study
• Pregnant or lactating women

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Laboratório de Aterosclerose e Bioquimica Nutricional

Belo Horizonte, Minas Gerais, 30161-970, Brazil

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Glutens

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Prolamins; Grain Proteins; Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Seed Storage Proteins

Study Officials

• Jacqueline I Alvarez-Leite, MD, PhD

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD.Ph.D

Model Details: All participants received placebo capsules and, after that, gluten capsules.

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 26, 2017
• Study Start: September 25, 2015
• Primary Completion: October 4, 2016
• Study Completion: October 4, 2016
• Last Updated: April 26, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)