Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Dietary supplement: Gluten; Dietary supplement: Rice protein

Detailed Description

Fibromyalgia (FM) is a chronic and widespread pain condition, usually accompanied by several associated symptoms such as fatigue, sleep disorder, headache, irritable bowel syndrome and mood disorders. Recent studies point to the possibility of gluten protein having a role in the development of FM symptoms in a subgroup of patients. Fourteen patients with FM diagnosis will be kept on a diet restrict in gluten-free foods for a period 10 weeks. At the 7th week they received rice protein isolate capsules (placebo) for 7 days, followed by a 3-day wash-out and a new challenge with capsules containing 8 g/day of gluten (corresponding to 6,3g gluten protein) for another 7 days. In the initial period, at 8th week (final of placebo period) and after challenge with gluten (10th week), blood will be collected for analysis of inflammatory markers. Questionnaires will be carried out to evaluate the quantity and severity of FM symptoms and the impact of FM on daily routine. Inflammatory markers (IL-1bera, IL-6 and IL-10) will be evaluated in the blood. In the challenger period (gluten or placebo) questionnaires will be carried out to evaluate the quantity and severity of symptoms related to fibromyalgia and the impact of fibromyalgia on a daily basis. In addition, a questionnaire based on Salerno protocol was applied to evaluate the presence of NCGS.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30161-970
      • Laboratório de Aterosclerose e Bioquimica Nutricional

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gluten; Capsules containing 8 g/day of gluten (6,3g of protein) were blindly administered for 7 days	Dietary supplement: Gluten
Placebo Comparator: Rice protein; Capsules containing 6,4 g/day of rice protein were blindly administered for 7 days	Dietary supplement: Rice protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in body weight	measured in weight in kg	Baseline, 8th and 10th weeks
Height	measured in meters	baseline
changes in BMI	in kg of body weight/square of height	Baseline, 8th and 10th weeks
Changes in IL-6 blood concentration	measure by ELISA in ug/mL	Baseline, 8th and 10th weeks
Changes in IL-10 blood concentration	measure by ELISA in ug/mL	Baseline, 8th and 10th weeks
Changes in IL-1beta blood concentration	measure by ELISA in ug/mL	Baseline, 8th and 10th weeks
changes in Food intake	measured in % of kcal	Baseline, 8th and 10th weeks

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais
• Investigators: Principal Investigator: Jacqueline I Alvarez-Leite, MD, PhD, Federal University of Minas Gerais

Study record dates

Study Major Dates

• Study Start: September 25, 2015
• Primary Completion (Actual): October 4, 2016
• Study Completion (Actual): October 4, 2016

Study Registration Dates

• First Submitted: April 19, 2017
• First Submitted That Met QC Criteria: April 21, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Actual): April 26, 2017
• Last Update Submitted That Met QC Criteria: April 21, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Fibromyalgia; non-celiac gluten sensitivity
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 48529415.8.0000.5149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No