Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-02-18 @ 12:56 AM
Study NCT ID:
NCT02568592
Status:
UNKNOWN
Last Update Posted:
2016-05-13
First Post:
2015-05-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Substrate Utilisation and Endurance Performance Following Short-term Manipulation of Dietary Fat Intake
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059305', 'term': 'Diet, High-Fat'}], 'ancestors': [{'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-11', 'studyFirstSubmitDate': '2015-05-13', 'studyFirstSubmitQcDate': '2015-10-02', 'lastUpdatePostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of fat oxidation during exercise', 'timeFrame': '90 minutes of sub-maximal exercise', 'description': 'Rates of fat oxidation to be measured via indirect calorimetry during 90 minutes of submaximal exercise'}], 'secondaryOutcomes': [{'measure': '5km running performance', 'timeFrame': 'Immediately following measurement of Primary Outcome measure', 'description': 'Time to complete 5km on a treadmill'}, {'measure': 'Change in plasma glucose concentration', 'timeFrame': '90 minutes sub-maximal exercise', 'description': 'Area under the plasma concentration versus time curve (AUC) of glucose'}, {'measure': 'Change in Free Fatty Acid concentration', 'timeFrame': '90 minutes sub-maximal exercise', 'description': 'Area under the plasma concentration versus time curve (AUC) of Free Fatty Acid'}, {'measure': 'Change in plasma glycerol concentration', 'timeFrame': '90 minutes sub-maximal exercise', 'description': 'Area under the plasma concentration versus time curve (AUC) of glycerol'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dietary Modification']}, 'descriptionModule': {'briefSummary': 'The capacity to burn fat as fuel for exercise may have important implications for sporting performance, with dietary fat intake positively influencing this ability.\n\nEndurance performance and the ability to burn fat will be measured in women runners following the consumption of 3 diets varying in the amount of fat and carbohydrate.', 'detailedDescription': 'Dietary fat intake positively influences the ability to burn fat during exercise in women but not men, whereas carbohydrate intake negatively influences fat oxidation in both sexes. The independent nature of dietary fat intake as a predictor of the ability to burn fat in women suggests that in conditions of adequate carbohydrate intake providing additional fat may increase fat oxidation in women whereas it does not in men. It is of interest to explore if indeed women are responsive (i.e., increase in fat oxidation) to short-term increases in dietary fat intake induced by overfeeding (adequate carbohydrate) or if as appears to be the case in men reduced carbohydrate intake as typically employed in high-fat, low carbohydrate dietary studies is also a prerequisite for enhancing fat oxidation in women, and whether this translates into a difference in exercise endurance performance.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\>17.0 \\< 25 kg/m2\n* Good General Health\n* Accustomed to vigorous physical activity\n* Run \\> 2 times per week\n* V̇O2max \\>50ml/kg/min\n* Weight Stable \\> last 6months\n* Non Smoker\n* Pre-menopausal, and either eumenorrheic and regularly menstruating, or using monophasic hormonal oral contraceptives for \\> 3 months.\n\nExclusion Criteria:\n\n* Currently taking part in another scientific/clinical study\n* Taking any prescription drug / supplement thought to influence metabolism\n* Following unusual dietary practices (such as intermittent fasting or low carbohydrate diets)\n* Pregnant\n* Breast Feeding'}, 'identificationModule': {'nctId': 'NCT02568592', 'briefTitle': 'Exercise Substrate Utilisation and Endurance Performance Following Short-term Manipulation of Dietary Fat Intake', 'organization': {'class': 'OTHER', 'fullName': 'University of Birmingham'}, 'officialTitle': 'Exercise Substrate Utilisation and Endurance Performance Following Short-term Manipulation of Dietary Fat Intake in Women', 'orgStudyIdInfo': {'id': 'ERN_15-0012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Fat', 'description': 'High Fat - Carbohydrate (20%), Fat (65%), Protein (15%)', 'interventionNames': ['Dietary Supplement: High Fat']}, {'type': 'EXPERIMENTAL', 'label': 'Normal', 'description': 'Normal - Carbohydrate (50%), Fat (35%) and Protein (15%)', 'interventionNames': ['Dietary Supplement: Normal']}, {'type': 'EXPERIMENTAL', 'label': 'Normal + Extra Fat', 'description': 'Normal + Extra Fat - Carbohydrate (50%), Fat (65%), Protein (15%). Carbohydrate and protein intake identical in absolute amounts to NORM (Normal), with an additional 30% extra energy coming from fat.', 'interventionNames': ['Dietary Supplement: Normal + Extra Fat']}], 'interventions': [{'name': 'High Fat', 'type': 'DIETARY_SUPPLEMENT', 'description': 'High Fat - Carbohydrate (20%), Fat (65%), Protein (15%)', 'armGroupLabels': ['High Fat']}, {'name': 'Normal', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Normal - Carbohydrate (50%), Fat (35%) and Protein (15%)', 'armGroupLabels': ['Normal']}, {'name': 'Normal + Extra Fat', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Normal + Extra Fat - Carbohydrate (50%), Fat (65%), Protein (15%). Carbohydrate and protein intake identical in absolute amounts to NORMAL, with an additional 30% extra energy coming from fat.', 'armGroupLabels': ['Normal + Extra Fat']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B15 2TT', 'city': 'Birmingham', 'state': 'West Midlands', 'country': 'United Kingdom', 'facility': 'University of Birmingham', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}], 'overallOfficials': [{'name': 'Gareth A Wallis, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}