Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:49 PM
Study NCT ID:
NCT06165393
Status:
RECRUITING
Last Update Posted:
2023-12-11
First Post:
2023-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Alginate Encapsulated Supplements on Athletic Performance and Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-01', 'studyFirstSubmitDate': '2023-12-01', 'studyFirstSubmitQcDate': '2023-12-01', 'lastUpdatePostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance', 'timeFrame': 'approx. 90 min-120 min', 'description': 'Time-To-Exhaustion performance test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Athletic Performance']}, 'descriptionModule': {'briefSummary': 'Endurance sport is often characterized by high training loads and significant metabolic demands, including depletion of endogenous fuel stores (e.g. liver and muscle glycogen) and damage to the skeletal muscle proteins. Nutritional interventions that enhance the restoration of endogenous fuel stores and improve muscle damage repair have received a lot of attention. The primary aim of this project is to clinically test the effect of alginate encapsulation technology on performance. Furthermore, we will investigate the substrate utilization profile during exercise and subsequent recovery.\n\nThe encapsulation technology presents a nutrient delivery solution, which results in a sustained or slow-release of the nutrients encapsulated. Thus, potentially optimizing the digestion and absorption by promoting an easy ingestion of high concentrations of fx carbohydrates without negatively affecting the gastrointestinal comfort.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, '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* accustumed to exercising on a bike\n* healthy volunteers\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 glycogen synthesis and/or performance.'}, 'identificationModule': {'nctId': 'NCT06165393', 'acronym': 'SWAP', 'briefTitle': 'The Effect of Alginate Encapsulated Supplements on Athletic Performance and Recovery', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'The Effect of Alginate Encapsulated Supplements on Athletic Performance and Recovery', 'orgStudyIdInfo': {'id': 'SWAP AU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Slow-release CHO-AA', 'description': 'Alginate encapsulated Carbohydrates and Amino Acids', 'interventionNames': ['Dietary Supplement: Slow-release CHO-AA']}, {'type': 'EXPERIMENTAL', 'label': 'Slow-release CHO', 'description': 'Alginate encapsulated Carbohydrates', 'interventionNames': ['Dietary Supplement: Slow-release CHO']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CHO', 'description': 'Carbohydrates only', 'interventionNames': ['Dietary Supplement: CHO']}], 'interventions': [{'name': 'Slow-release CHO-AA', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Slow-release CHO-AA, alginate encapsulated', 'armGroupLabels': ['Slow-release CHO-AA']}, {'name': 'Slow-release CHO', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Slow-release CHO, alginate encapsulated', 'armGroupLabels': ['Slow-release CHO']}, {'name': 'CHO', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Carbohydrate-only, control', 'armGroupLabels': ['CHO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus N', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Per B Jeppesen, Ph.d', 'role': 'CONTACT', 'email': 'per.bendix.jeppesen@clin.au.dk', 'phone': '28151877'}, {'name': 'Lotte L Nielsen', 'role': 'CONTACT', 'email': 'lln@clin.au.dk', 'phone': '+45 22995827'}], 'facility': 'Per Bendix Jeppesen', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}], 'centralContacts': [{'name': 'Per B Jeppesen, PhD', 'role': 'CONTACT', 'email': 'per.bendix.jeppesen@clin.au.dk', 'phone': '+4528151877'}, {'name': 'Lotte L Nielsen, M.Sc.', 'role': 'CONTACT', 'email': 'lln@clin.au.dk', 'phone': '+4522995827'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Innovation Fund Denmark', 'class': 'INDIV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate. Prof, PhD.', 'investigatorFullName': 'Per Bendix Jeppesen', 'investigatorAffiliation': 'University of Aarhus'}}}}