Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients

Conditions
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Fibromyalgia

Intervention / Treatment
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* Dietary Supplement: Gluten
* Dietary Supplement: Rice protein


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: All participants received placebo capsules and, after that, gluten capsules.
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia; non-celiac gluten sensitivity