Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-26 @ 6:25 PM
Study NCT ID:
NCT02177604
Status:
TERMINATED
Last Update Posted:
2018-05-25
First Post:
2014-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can Brief High-intensity Interval Training Mitigate the Adverse Consequences of High-fat Overfeeding?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Lack of funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-23', 'studyFirstSubmitDate': '2014-06-19', 'studyFirstSubmitQcDate': '2014-06-25', 'lastUpdatePostDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in mitochondrial metabolism', 'timeFrame': '1 week', 'description': 'Changes in citrate synthase activity, mitochondrial DNA content and protein levels of PGC-1a'}, {'measure': 'Change in resting energy expenditure', 'timeFrame': '1 week', 'description': 'Changes in resting energy expenditure measured by metabolic cart'}, {'measure': 'Change in cognitive function', 'timeFrame': '1 week', 'description': 'Changes in cognitive function, assessed by a series of computer tasks involving vigilant attention and speed processing.'}], 'primaryOutcomes': [{'measure': 'Change in glucose metabolism', 'timeFrame': '1 week', 'description': 'Changes in insulin and glucose area under the curve assessed via 75g Oral Glucose Tolerance Test.'}], 'secondaryOutcomes': [{'measure': 'Change in plasma levels of cytokines', 'timeFrame': '1 week', 'description': 'Change in plasma levels of adiponectin, irisin, sex hormone-binding globulin and c-reactive protein'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Insulin Resistance']}, 'descriptionModule': {'briefSummary': 'Previous research has shown that indulging in 50% more calories than required for as little as 3 days can significantly impact markers of metabolic health in lean and overweight individuals. Here, the investigators will determine if 3 brief sessions of high-intensity interval training can mitigate the adverse consequences of 7 days high-fat overfeeding in sedentary, overweight males.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sedentary (no more than 2 sessions of structured moderate intensity aerobic exercise or resistance training per week)\n* Overweight (BMI 25-29.9 kg/m2)\n\nExclusion Criteria:\n\n* Personal history of any major illness (i.e. cardiovascular disease, diabetes, hypertension, cancer, renal/liver impairments, major psychiatric disorders, eating disorders etc.)\n* History of chest pain (either at rest or during exercise.)\n* Abnormal resting ECG at screening visit\n* Chronic use of any prescribed or non-prescribed medications (i.e. anti-hypertensive, statins, metformin, anti-inflammatories, antidepressants etc.)\n* Blood pressure or blood lipids outside of reference ranges\n* Serum ferritin \\<30ng/mL\n* Uncontrolled asthma, current fever, or upper respiratory infection\n* Current intake of \\> 140g alcohol/week\n* Current smokers of cigarettes/cigars/marijuana\n* Current intake of any illicit substance\n* Experience claustrophobia in confined spaces\n* Donated blood in the past 3 months\n* Migraines\n* Unable to comprehend study protocol\n* Unable to perform exercise on a cycle ergometer at second screening visit'}, 'identificationModule': {'nctId': 'NCT02177604', 'acronym': 'GAINHIT', 'briefTitle': 'Can Brief High-intensity Interval Training Mitigate the Adverse Consequences of High-fat Overfeeding?', 'organization': {'class': 'OTHER', 'fullName': 'University of Adelaide'}, 'officialTitle': 'Can Brief High-intensity Interval Training Mitigate the Adverse Consequences of High-fat Overfeeding?', 'orgStudyIdInfo': {'id': '140319'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wingate HIT', 'description': '7 days of high-fat overfeeding (50% excess calories) in conjunction 3 supervised sessions of Wingate High-intensity Interval Training.', 'interventionNames': ['Other: Wingate HIT', 'Other: High-fat overfeeding']}, {'type': 'EXPERIMENTAL', 'label': 'Modified HIT', 'description': '7 days of high-fat overfeeding (50% excess calories) in conjunction with 3 supervised sessions of Modified High-Intensity Interval Training', 'interventionNames': ['Other: Modified HIT', 'Other: High-fat overfeeding']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No Exercise Control', 'description': '7 days of high-fat overfeeding (50% excess calories) with no supervised exercise', 'interventionNames': ['Other: High-fat overfeeding']}], 'interventions': [{'name': 'Wingate HIT', 'type': 'OTHER', 'description': '3 sessions of Wingate based High-Intensity Interval Training (6-8 x 15 second "all out" sprints on a cycle ergometer interspersed by 2 minutes recovery)', 'armGroupLabels': ['Wingate HIT']}, {'name': 'Modified HIT', 'type': 'OTHER', 'description': '3 sessions of Modified High-Intensity Interval Training (8 x 60 second sprints at approximately 90-95% VO2 peak on a cycle ergometer interspersed by 60 seconds recovery)', 'armGroupLabels': ['Modified HIT']}, {'name': 'High-fat overfeeding', 'type': 'OTHER', 'description': '7 days of high-fat overfeeding (50% excess calories)', 'armGroupLabels': ['Modified HIT', 'No Exercise Control', 'Wingate HIT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'South Australian Health & Medical Research Institute', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}], 'overallOfficials': [{'name': 'Leonie Heilbronn, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Adelaide'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Adelaide', 'class': 'OTHER'}, 'collaborators': [{'name': 'Royal Adelaide Hospital', 'class': 'OTHER'}, {'name': 'University of South Australia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'A/Prof Leonie Heilbronn', 'investigatorAffiliation': 'University of Adelaide'}}}}