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Trial record 7 of 777 for:    fibromyalgia

Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients

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ClinicalTrials.gov Identifier: NCT03129906
Recruitment Status : Completed
First Posted : April 26, 2017
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Jacqueline Isaura Alvarez Leite, Federal University of Minas Gerais

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Dietary Supplement: Gluten Dietary Supplement: Rice protein Not Applicable

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  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: All participants received placebo capsules and, after that, gluten capsules.
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients
Study Start Date : September 25, 2015
Actual Primary Completion Date : October 4, 2016
Actual Study Completion Date : October 4, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

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



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03129906


Locations
Brazil
Laboratório de Aterosclerose e Bioquimica Nutricional
Belo Horizonte, Minas Gerais, Brazil, 30161-970
Sponsors and Collaborators
Federal University of Minas Gerais
Investigators
Principal Investigator: Jacqueline I Alvarez-Leite, MD, PhD Federal University of Minas Gerais

Responsible Party: Jacqueline Isaura Alvarez Leite, MD.Ph.D, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT03129906     History of Changes
Other Study ID Numbers: 48529415.8.0000.5149
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jacqueline Isaura Alvarez Leite, Federal University of Minas Gerais:
Fibromyalgia; non-celiac gluten sensitivity

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases