Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT05881018
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2023-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigating the Effects of Diet and Physical Activity on Esport Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-06', 'studyFirstSubmitDate': '2023-04-12', 'studyFirstSubmitQcDate': '2023-05-26', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in esport performance (test battery)', 'timeFrame': '4 weeks', 'description': 'Reaction time will be measured using an esport test battery'}], 'secondaryOutcomes': [{'measure': 'Glucose response (continuous glucose monitor): 3h iAUC', 'timeFrame': '4 weeks', 'description': 'The 3h incremental area under the curve (iAUC) will be used to assess glycemic response to the drink. Unit: mg/dL'}, {'measure': 'Glycaemic variability (continuous glucose monitor): 24h MAGE', 'timeFrame': '4 weeks', 'description': 'The mean amplitude of glycemic excursion during 24h will be assessed as an indicator for glycemic variability. Unit: mg/dL'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sports Physical Therapy', 'Dietary Habits', 'Diet, Healthy']}, 'descriptionModule': {'briefSummary': 'A randomized, counterbalanced intervention study in esport players.', 'detailedDescription': 'The study will test whether i) the consumption of two different carbohydrate drinks and ii) the performance of regular high-intensity interval training will impact esport performance and metabolic profile.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent obtained\n* Male or female aged 18-45 years\n* Healthy\n* Participants have to be part of an esport association and/or regularly participate in tournaments\n\nExclusion Criteria:\n\n* diabetes mellitus type 1 or 2 (T1DM or T2DM)\n* medication which impacts glucose metabolism or visual perception\n* health issues like cardiovascular diseases, severe orthopaedic conditions or neurological impairments\n* food allergies or intolerances, e.g. fructose malabsorption'}, 'identificationModule': {'nctId': 'NCT05881018', 'briefTitle': 'Investigating the Effects of Diet and Physical Activity on Esport Performance', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beneo-Institute'}, 'officialTitle': 'Investigating the Effects of Diet and Physical Activity on Esport Performance', 'orgStudyIdInfo': {'id': 'ES01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low glycaemic index', 'interventionNames': ['Dietary Supplement: Low glycaemic index']}, {'type': 'EXPERIMENTAL', 'label': 'Low glycaemic index with physical activity units', 'interventionNames': ['Dietary Supplement: Low glycaemic index', 'Behavioral: Physical activity']}, {'type': 'EXPERIMENTAL', 'label': 'High glycaemic index', 'interventionNames': ['Dietary Supplement: High glycaemic index']}, {'type': 'EXPERIMENTAL', 'label': 'High glycaemic index with physical activity units', 'interventionNames': ['Dietary Supplement: High glycaemic index', 'Behavioral: Physical activity']}], 'interventions': [{'name': 'Low glycaemic index', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Diet will be supplemented with a drink containing a low glycaemic index carbohydrate', 'armGroupLabels': ['Low glycaemic index', 'Low glycaemic index with physical activity units']}, {'name': 'High glycaemic index', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Diet will be supplemented with a drink containing a high glycaemic index carbohydrate', 'armGroupLabels': ['High glycaemic index', 'High glycaemic index with physical activity units']}, {'name': 'Physical activity', 'type': 'BEHAVIORAL', 'description': 'Participants will include physical activity units', 'armGroupLabels': ['High glycaemic index with physical activity units', 'Low glycaemic index with physical activity units']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cologne', 'country': 'Germany', 'facility': 'German Sports University Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beneo-Institute', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'German Sport University, Cologne', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}