Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-01-01 @ 6:37 AM
Study NCT ID:
NCT05207332
Status:
COMPLETED
Last Update Posted:
2022-01-26
First Post:
2019-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of a Vegan Alginate Product on Athletes Recovery and Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C101948', 'term': 'CVS 1123'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-25', 'studyFirstSubmitDate': '2019-03-14', 'studyFirstSubmitQcDate': '2022-01-25', 'lastUpdatePostDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance', 'timeFrame': 'Aprox. 120 minutes', 'description': 'Time-to-exhaustion. Measured by the duration of high intensity exercise performed to exhaustion.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Athletic Performance']}, 'descriptionModule': {'briefSummary': 'The feeding strategies during recovery are essential to optimize a subsequent performance. Carbohydrate is a major fuel source during exercise as it has been shown to maintain high rates of carbohydrate oxidation. Protein intake in combination with carbohydrate have been shown to increase Amino acid bioavailability and may alter physiologic responses during exercise, which may be relevant to endurance performance. The goal of this study is to assess the effect of a new developed vegan product on athletes recovery and subsequent performance.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* males between 18-50 years of age\n* moderate to trained individuals with a VO2max \\> 50 ml/min/kg\n\nExclusion Criteria:\n\n* persons diagnosed with metabolic diseases (i.e. Type 2 Diabetes) which relates to the carbohydrate metabolism.\n* persons ingesting prescribed drugs/medicin, supplements or a special diet (i.e. low carbohydrate), which might affect the glykogen synthesis and/or performance.'}, 'identificationModule': {'nctId': 'NCT05207332', 'briefTitle': 'The Effect of a Vegan Alginate Product on Athletes Recovery and Performance', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'The Effect of a Vegan Alginate Product on Athletes Recovery and Performance', 'orgStudyIdInfo': {'id': 'VEGSPORT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vegan product', 'interventionNames': ['Dietary Supplement: CHO+PRO']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'interventionNames': ['Dietary Supplement: CHO']}], 'interventions': [{'name': 'CHO+PRO', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A vegan product containing carbohydrate and protein', 'armGroupLabels': ['Vegan product']}, {'name': 'CHO', 'type': 'DIETARY_SUPPLEMENT', 'description': 'containing carbohydrate', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Per Bendix Jeppesen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Future Food Innovation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate professor, Ph.D.', 'investigatorFullName': 'Per Bendix Jeppesen', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}