Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients

Fibromyalgia Clinical Trial

Official title:

Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03129906
• Other study ID #: 48529415.8.0000.5149
• Status: Completed
• Phase: N/A
• First received: April 19, 2017
• Last updated: April 21, 2017
• Start date: September 25, 2015
• Est. completion date: October 4, 2016

Study information

• Verified date: April 2017
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 4, 2016
• Est. primary completion date: October 4, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Dietary Supplement:
• Gluten

• Rice protein

Locations

Country	Name	City	State
Brazil	Laboratório de Aterosclerose e Bioquimica Nutricional	Belo Horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

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