Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-30 @ 9:12 AM
Study NCT ID:
NCT03903861
Status:
COMPLETED
Last Update Posted:
2023-01-04
First Post:
2019-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Galactose Mediated Glycogen Resynthesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005947', 'term': 'Glucose'}, {'id': 'D005690', 'term': 'Galactose'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-03', 'studyFirstSubmitDate': '2019-03-29', 'studyFirstSubmitQcDate': '2019-04-03', 'lastUpdatePostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle glycogen synthesis rates (mmol/kg/dm/h)', 'timeFrame': '4 hours', 'description': 'Muscle glycogen synthesis rates over the post-exercise recovery period'}], 'secondaryOutcomes': [{'measure': 'Carbohydrate oxidation rates (g/min)', 'timeFrame': 'Up to 90 minutes', 'description': 'Total, exogenous and endogenous carbohydrate oxidation during a secondary bout of exercise'}, {'measure': 'Fat oxidation rates (g/min)', 'timeFrame': 'Up to 90 minutes', 'description': 'Fat oxidation during a secondary bout of exercise'}, {'measure': 'Plasma glucose (mmol/L)', 'timeFrame': 'Up to 6 hours', 'description': 'Plasma glucose during the post-exercise recovery period and during a secondary bout of exercise'}, {'measure': 'Serum insulin (mU/L)', 'timeFrame': 'Up to 6 hours', 'description': 'Serum insulin during the post-exercise recovery period and during a secondary bout of exercise'}, {'measure': 'Plasma galactose (mmol/L)', 'timeFrame': 'Up to 6 hours', 'description': 'Plasma galactose during the post-exercise recovery period and during a secondary bout of exercise'}, {'measure': 'Plasma lactate (mmol/L)', 'timeFrame': 'Up to 6 hours', 'description': 'Plasma lactate during the post-exercise recovery period and during a secondary bout of exercise'}, {'measure': 'Plasma non-esterified fatty acids (mmol/L)', 'timeFrame': 'Up to 6 hours', 'description': 'Plasma non-esterified fatty acids during the post-exercise recovery period and during a secondary bout of exercise'}, {'measure': 'Plasma glycerol (umol/L)', 'timeFrame': 'Up to 6 hours', 'description': 'Plasma glycerol during the post-exercise recovery period and during a secondary bout of exercise'}, {'measure': 'Plasma glucagon (pmol/L)', 'timeFrame': 'Up to 6 hours', 'description': 'Plasma glucagon during the post-exercise recovery period and during a secondary bout of exercise'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Exercise']}, 'descriptionModule': {'briefSummary': 'This study will compare short-term post-exercise muscle glycogen synthesis following combined galactose-glucose, glucose alone or galactose alone ingestion.', 'detailedDescription': 'Lactose, the sugar contained within milk, consists of glucose and galactose. Post-exercise consumption of a carbohydrate mixture containing glucose with galactose has been shown to accelerate liver glycogen repletion as compared to glucose-only provision. However, the extent to which galactose-glucose combinations influence post-exercise muscle glycogen storage has yet to be determined.\n\nTherefore, this study will investigate whether short-term muscle glycogen storage after strenuous endurance exercise is enhanced by combined galactose-glucose or glucose only ingestion as compared to the ingestion of galactose alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:.\n\n* Body mass index in the range: 18.5 - 27.5 kg/m2\n* Participates in endurance-based exercise (e.g. cycling, running, rowing) at least 3 times per week\n* Aerobic fitness: VO2max \\>45 ml/kg/min (men), \\>40 ml/kg/min (women)\n\nExclusion Criteria:\n\n* Lidocaine allergy\n* Current participation in another scientific/clinical study\n* Bleeding disorder/s\n* Current or recent smoker to include vaping (last 60 days)\n* Vegan\n* Existence of food intolerances\n* Poor recent health as indicated in the general health questionnaire\n* Engage in uncommon eating practices (e.g. sustained periods of fasting)\n* Diagnosed with galactosemia'}, 'identificationModule': {'nctId': 'NCT03903861', 'briefTitle': 'Galactose Mediated Glycogen Resynthesis', 'organization': {'class': 'OTHER', 'fullName': 'University of Birmingham'}, 'officialTitle': 'Galactose Mediated Glycogen Resynthesis and the Effects on Metabolism During Subsequent Exercise', 'orgStudyIdInfo': {'id': 'ERN_19-0308'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glucose alone', 'description': 'Participants will complete a glycogen depleting bout of exercise followed by the provision of glucose-alone over 4 hours of recovery before a subsequent bout of exercise.', 'interventionNames': ['Other: Glucose alone']}, {'type': 'EXPERIMENTAL', 'label': 'Galactose alone', 'description': 'Participants will complete a glycogen depleting bout of exercise followed by the provision of galactose-alone over 4 hours of recovery before a subsequent bout of exercise.', 'interventionNames': ['Other: Galactose alone']}, {'type': 'EXPERIMENTAL', 'label': 'Glucose and galactose', 'description': 'Participants will complete a glycogen depleting bout of exercise followed by the provision of glucose and galactose over 4 hours of recovery before a subsequent bout of exercise.', 'interventionNames': ['Other: Glucose and galactose']}], 'interventions': [{'name': 'Glucose alone', 'type': 'OTHER', 'description': 'Young men or women will complete a glycogen depleting bout of exercise followed by the provision of glucose-alone over 4 hours of recovery before a subsequent bout of exercise.', 'armGroupLabels': ['Glucose alone']}, {'name': 'Galactose alone', 'type': 'OTHER', 'description': 'Young men or women will complete a glycogen depleting bout of exercise followed by the provision of galactose-alone over 4 hours of recovery before a subsequent bout of exercise.', 'armGroupLabels': ['Galactose alone']}, {'name': 'Glucose and galactose', 'type': 'OTHER', 'description': 'Young men or women will complete a glycogen depleting bout of exercise followed by the provision of glucose and galactose over 4 hours of recovery before a subsequent bout of exercise.', 'armGroupLabels': ['Glucose and galactose']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B15 2TT', 'city': 'Birmingham', 'state': 'West Midlands', 'country': 'United Kingdom', 'facility': 'School of Sport, Exercise and Rehabilitation Sciences', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}], 'overallOfficials': [{'name': 'Gareth Wallis, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dairy Management Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}