Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2026-03-03 @ 9:15 PM
Study NCT ID:
NCT03129932
Status:
COMPLETED
Last Update Posted:
2020-07-31
First Post:
2017-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects Gluten Intake on Body Composition, Energy Expenditure and Adipokine Profile in Non-celiac Women With Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'volunteers will receive placebo or gluten corn muffins that are similar in taste and appearance. Investigator does not know who is receiving placebo or gluten muffins. During analyses, each sample is coded to avoid volunteer or phase identification.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'double-masked, crossover, randomized, controlled study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-29', 'studyFirstSubmitDate': '2017-04-21', 'studyFirstSubmitQcDate': '2017-04-21', 'lastUpdatePostDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in body Weight', 'timeFrame': '1st, 4th and 8th weeks', 'description': 'measured in scale presented in kg'}], 'secondaryOutcomes': [{'measure': 'Height', 'timeFrame': '1st week', 'description': 'measured in meters'}, {'measure': 'Changes in BMI', 'timeFrame': '1st, 4th and 8th weeks', 'description': 'calculated by body weigh / square of height'}, {'measure': 'Changes in resting metabolic rate', 'timeFrame': '1st, 4th and 8th weeks', 'description': 'measured by indirect calorimetry in kcal/kg or kcal/day'}, {'measure': 'Changes in macronutrient intake', 'timeFrame': '1st, 4th and 8th weeks', 'description': 'calculation of food intake based on 24h diary - result in % kcal'}, {'measure': 'waist circumference', 'timeFrame': '1st, 4th and 8th weeks', 'description': 'measured in cm'}, {'measure': 'Changes in IL-6 blood concentration', 'timeFrame': '1st, 4th and 8th weeks', 'description': 'measure by ELISA in ug/mL'}, {'measure': 'Changes in IL-10', 'timeFrame': '1st, 4th and 8th weeks', 'description': 'blood concentration measure by ELISA in ug/mL'}, {'measure': 'Changes in IL-1beta', 'timeFrame': '1st, 4th and 8th weeks4th and 8th weeks', 'description': 'blood concentration measure by ELISA in ug/mL'}, {'measure': 'Changes in Adiponectin', 'timeFrame': '1st, 4th and 8th weeks', 'description': 'blood concentration measure by ELISA in ug/mL'}, {'measure': 'Changes in Leptin', 'timeFrame': '1st, 4th and 8th weeks', 'description': 'blood concentration measure by ELISA in ug/mL'}, {'measure': 'Changes in C reactive protein', 'timeFrame': '1st, 4th and 8th weeks', 'description': 'blood concentration measure in mg/mL'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gluten', 'adipokine', 'obesity', 'diet'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'This is a double-masked, crossover, randomized, controlled study that aims to evaluate, in women with obesity, a possible influence of wheat gluten on food choices, body weight, resting metabolism and circulating inflammation markers and adipokines. The volunteers will be randomized into two groups, half of them will initiate the experiment by taking 2 placebo muffins daily for 4 weeks (Placebo phase) and the remnant volunteers will take 2 corn muffins containing 12g of gluten/each for 4 weeks (Gluten phase). At the 1st, 4th and 8th experimental weeks will be evaluated body weight, body composition, lipid profile, glucose, insulin, leptin, adiponectin, and inflammatory markers.', 'detailedDescription': 'It is a double-masked, crossover, randomized, controlled study. For this, volunteers will be kept on gluten-free diet for 8 weeks. At the first moment, a structured Food Frequency Questionnaire will be applied, as well as a 72-hour food register, to evaluate routine of food consumption and daily intake of gluten. The volunteers will be randomized into two groups, half of them will initiate the experiment by taking 2 placebo muffins daily for 4 weeks (Placebo phase) and the remnant volunteers will take 2 corn muffins containing 12g of gluten/each for 4 weeks (Gluten phase). After that, volunteers will be transferred for the other phase for 4 more weeks. During the 8 experimental weeks, all volunteers will be instructed to exclude any food containing gluten from their diet. At the 1st, 4th and 8th experimental weeks after 12 hours of fasting and 30 minutes of resting, volunteers will be submitted to indirect calorimetry, electrical bioimpedance, blood collection and anthropometry (weight and height). The volunteers will also respond a questionnaire about life habits, family history, previous history, physical activity and food frequency. Blood samples will be used to assess blood count, lipid profile, glucose, insulin, leptin, adiponectin, and inflammatory markers (soluble VCAM, C-reactive protein, fibrinogen). Four weeks after the end of the experiment, and return to the alimentary routine, body weight, blood sample, calorimetry and bioimpedance will be reassessed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women between 20 and 50 years without diagnosis of celiac disease\n* overweight and obese, respectively, BMI of 24.9- 34.9\n* without menopause\n\nExclusion Criteria:\n\n\\- Subjects with positive serology for celiac disease or allergy to wheat'}, 'identificationModule': {'nctId': 'NCT03129932', 'briefTitle': 'Effects Gluten Intake on Body Composition, Energy Expenditure and Adipokine Profile in Non-celiac Women With Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Minas Gerais'}, 'officialTitle': 'Effects Gluten on Body Composition, Energy Expenditure and Adipokine Profile in Non-celiac Women With Obesity', 'orgStudyIdInfo': {'id': '49480215.0.0000.5149'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'gluten phase', 'description': 'volunteers will receive 2 corn muffins containing12g of gluten/muffin to be consumed daily for 4 weeks', 'interventionNames': ['Dietary Supplement: gluten phase']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo phase', 'description': 'volunteers will receive 2 corn muffins without gluten/muffin to be consumed daily for 4 weeks', 'interventionNames': ['Dietary Supplement: placebo phase']}], 'interventions': [{'name': 'gluten phase', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 cakes containing 9g of vital gluten/each will be consume during the 4 weeks of intervention', 'armGroupLabels': ['gluten phase']}, {'name': 'placebo phase', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 cakes without gluten will be consume during the 4 weeks of intervention', 'armGroupLabels': ['Placebo phase']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'JAQUELINE I ALVAREZ-LEITE, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Minas Gerais'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jacqueline Isaura Alvarez Leite', 'class': 'OTHER'}, 'collaborators': [{'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}, {'name': 'Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD.Ph.D; Full Professor', 'investigatorFullName': 'Jacqueline Isaura Alvarez Leite', 'investigatorAffiliation': 'Federal University of Minas Gerais'}}}}