Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-03-13 @ 3:07 AM
Study NCT ID:
NCT01773356
Status:
COMPLETED
Last Update Posted:
2015-09-25
First Post:
2013-01-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Dihydrocapsiate on Energy Expenditure in Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C470213', 'term': 'capsiate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-24', 'studyFirstSubmitDate': '2013-01-15', 'studyFirstSubmitQcDate': '2013-01-17', 'lastUpdatePostDateStruct': {'date': '2015-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resting Energy Expenditure', 'timeFrame': 'Change from Baseline at 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Thermic effect of feeding', 'timeFrame': 'Change from baseline at 12 weeks'}, {'measure': 'Body Composition', 'timeFrame': 'Change from baseline at 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity', 'Body Weight', 'Body Composition', 'Metabolism', 'Resting Energy Expenditure'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to test the effect of dihydrocapsiate on energy expenditure in women.', 'detailedDescription': 'Capsaicin, a substance found in chili pepper, is known to stimulate thermogenesis. Dihydrocapsiate, a capsinoid, found in the non-pungent CH-19 sweet pepper has similar thermogenic effects without the gastrointestinal side effects. The objective of this project is to test the effect of 12 weeks of daily consumption of 9 mg dihydrocapsiate on resting energy expenditure relative to baseline when compared to a control group consuming products without DCT.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI: 18.5-34.5 kg/m2\n* Good general health\n* Low to mild physical activity\n* Willing to maintain habitual diet and physical activity patterns throughout the study period\n* Premenopausal and cycling regularly or using oral contraceptives\n* Willing to attend study visits only during the follicular phase or bleed phase of their menstrual cycle\n* Understands study procedures and signs forms providing informed consent to participate in the study\n* Have spoken and written English literacy\n\nExclusion Criteria:\n\n* Diabetes mellitus or any conditions that might affect energy metabolism\n* Weight change ±2 kg over previous three months\n* Known sensitivity or allergy to ingredients of the study products\n* Non-breakfast eater\n* Recent use of antibiotics\n* History of smoking during the six months prior to study\n* Recent signs or symptoms of infection, including cold or flu-like symptoms\n* Concurrent or recent intervention study participation\n* Instability in breathing patterns or energy expenditure measures\n* History of drug or alcohol abuse\n* Lipid-lowering, anti-hypertensive or anti-inflammatory steroid medication use\n* Weight loss medication\n* Pregnant or lactating\n* Unwilling to be randomized to any experimental group and unable to meet all requirements of the study'}, 'identificationModule': {'nctId': 'NCT01773356', 'briefTitle': 'Effect of Dihydrocapsiate on Energy Expenditure in Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Georgia'}, 'officialTitle': 'Randomized, Controlled, Parallel Trial to Evaluate the Effects of Dihydrocapsiate on Energy Expenditure in Women', 'orgStudyIdInfo': {'id': 'WASABI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo 0 mg/d', 'description': '0 mg/d of Dihydrocapsiate will be consumed in ready to ear cereal, cereal bars or crackers', 'interventionNames': ['Dietary Supplement: Dihydrocapsiate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dihydrocapsiate 9 mg/d', 'description': '9 mg/d of Dihydrocapsiate will be consumed in ready to ear cereal, cereal bars or crackers', 'interventionNames': ['Dietary Supplement: Dihydrocapsiate']}], 'interventions': [{'name': 'Dihydrocapsiate', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Natural substances present in sweet chili peppers'], 'description': "Kellogg's ready to eat cereal, cereal bars, and crackers will contain dihyrocapsiate or placebo. Daily consumption of dihydrocapsiate is 9mg/d or 0mg/d.", 'armGroupLabels': ['Dihydrocapsiate 9 mg/d', 'Placebo 0 mg/d']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30602-6554', 'city': 'Athens', 'state': 'Georgia', 'country': 'United States', 'facility': 'University of Georgia, Department of Kinesiology', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}], 'overallOfficials': [{'name': 'Ellen M Evans, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Georgia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ellen Evans', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kellogg Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr Ellen Evans', 'investigatorFullName': 'Ellen Evans', 'investigatorAffiliation': 'University of Georgia'}}}}