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Completed

NCT Number: NCT03129906

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Laboratório de Aterosclerose e Bioquimica Nutricional

Belo Horizonte, Minas Gerais, 30161-970, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gluten

Dietary Supplement

Rice Protein

Dietary Supplement

Primary outcomes

  1. Changes in fibromyalgia Symptoms by Salerno protocol

    Time frame: Baseline, 4th and 8th weeks, 10th week

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

Secondary outcomes

  1. Changes in body weight

    Time frame: Baseline, 8th and 10th weeks

    measured in weight in kg

  2. Height

    Time frame: baseline

    measured in meters

  3. changes in BMI

    Time frame: Baseline, 8th and 10th weeks

    in kg of body weight/square of height

  4. Changes in IL-6 blood concentration

    Time frame: Baseline, 8th and 10th weeks

    measure by ELISA in ug/mL

  5. Changes in IL-10 blood concentration

    Time frame: Baseline, 8th and 10th weeks

    measure by ELISA in ug/mL

  6. Changes in IL-1beta blood concentration

    Time frame: Baseline, 8th and 10th weeks

    measure by ELISA in ug/mL

  7. changes in Food intake

    Time frame: Baseline, 8th and 10th weeks

    measured in % of kcal

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 26, 2017
Registry last updated
Apr 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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