Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-03-21 @ 6:21 PM
Study NCT ID:
NCT03089593
Status:
COMPLETED
Last Update Posted:
2017-06-21
First Post:
2017-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thermogenic Effect of Ginger
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002482', 'term': 'Cellulose'}], 'ancestors': [{'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-20', 'studyFirstSubmitDate': '2017-03-08', 'studyFirstSubmitQcDate': '2017-03-19', 'lastUpdatePostDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in postprandial energy expenditure', 'timeFrame': 'Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial', 'description': 'Energy expenditure will be assessed by indirect calorimetry'}], 'secondaryOutcomes': [{'measure': 'Change in oxygen consumption', 'timeFrame': 'Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial', 'description': 'Oxygen consumption will be assessed by indirect calorimetry'}, {'measure': 'Change in blood pressure', 'timeFrame': 'Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial', 'description': 'Blood pressure will be assessed using digital sphygmomanometer'}, {'measure': 'Change in axillary temperature', 'timeFrame': 'Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial', 'description': 'Axillary temperature will be assessed using a digital thermometer'}, {'measure': 'Change in metabolic profile', 'timeFrame': 'Baseline and thereafter at 30, 60, 120 and 240 minutes postprandial', 'description': 'Total cholesterol'}, {'measure': 'Change in heart rate', 'timeFrame': 'Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial', 'description': 'Heart rate will be assessed using digital sphygmomanometer'}, {'measure': 'Change in metabolic profile', 'timeFrame': 'Baseline and thereafter at 30, 60, 120 and 240 minutes postprandial', 'description': 'Glucose levels'}, {'measure': 'Change in metabolic profile', 'timeFrame': 'Baseline and thereafter at 30, 60, 120 and 240 minutes postprandial', 'description': 'HDL-cholesterol'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thermic Effect of Food', 'Energy Expenditure', 'Ginger'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '33487261', 'type': 'DERIVED', 'citation': 'Fagundes GBP, Rodrigues AMDS, Martins LB, Monteze NM, Correia MITD, Teixeira AL, Ferreira AVM. Acute effects of dry extract of ginger on energy expenditure in eutrophic women: A randomized clinical trial. Clin Nutr ESPEN. 2021 Feb;41:168-174. doi: 10.1016/j.clnesp.2020.10.001. Epub 2020 Nov 9.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of the study is to evaluate the thermogenic effect of ginger.', 'detailedDescription': 'Healthy and eutrophic women will receive capsules of 200 mg of ginger extract (5% active ingredient) or placebo (cellulose), along with a standardized breakfast, with a minimum seven days washout period.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females;\n* Aged between 18 and 60 years old;\n* Body mass index between 18.5 and 24.9 kg/m²;\n* Agree to sign the informed consent.\n\nExclusion Criteria:\n\n* Any chronic health conditions (e.g. diabetes, hypertension, chronic renal failure, heart and liver disease);\n* Previous operation for weight loss;\n* Medications known to affect total energy expenditure;\n* Pregnancy and breast-feeding;\n* Smoking;\n* Alcohol use (\\>2 doses/day).'}, 'identificationModule': {'nctId': 'NCT03089593', 'briefTitle': 'Thermogenic Effect of Ginger', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Minas Gerais'}, 'officialTitle': 'Double-blind Placebo-controlled Clinical Trial of Thermogenic Effect of Ginger (Zingiber Officinale) in Eutrophic Women', 'orgStudyIdInfo': {'id': 'UFMG 30409114.8.0000.5149'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Extract of ginger', 'description': 'Healthy and eutrophic women will receive two capsules of 200 mg of ginger extract (5% gingerols) to be taken along with a standardized breakfast.', 'interventionNames': ['Other: Extract of ginger']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cellulose', 'description': 'Healthy and eutrophic women will receive two capsules of 200 mg of placebo (cellulose) to be taken along with a standardized breakfast.', 'interventionNames': ['Other: Placebo (Cellulose)']}], 'interventions': [{'name': 'Extract of ginger', 'type': 'OTHER', 'description': 'The volunteers will receive two capsules containing 200mg of extract of ginger with 5% of gingerols (20 mg). Breakfast will be offered (bread, butter, turkey ham and industrialized fruit juice) and the participants will have 15 minutes to eat it.', 'armGroupLabels': ['Extract of ginger']}, {'name': 'Placebo (Cellulose)', 'type': 'OTHER', 'description': 'The volunteers will receive two capsules containing cellulose (placebo). Breakfast will be offered (bread, butter, turkey ham and industrialized fruit juice) and the participants will have 15 minutes to eat it.', 'armGroupLabels': ['Cellulose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30130-100', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Hospital das Clínicas', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}], 'overallOfficials': [{'name': 'Gabriela BP Fagundes', 'role': 'STUDY_CHAIR', 'affiliation': 'Federal University of Minas Gerais'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Minas Gerais', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, PhD', 'investigatorFullName': 'Adaliene Versiani M. Ferreira', 'investigatorAffiliation': 'Federal University of Minas Gerais'}}}}