Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-30 @ 1:18 PM
Study NCT ID:
NCT06363669
Status:
COMPLETED
Last Update Posted:
2024-04-12
First Post:
2024-04-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Caffeine-based Supplement on Physical Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-08', 'studyFirstSubmitDate': '2024-04-08', 'studyFirstSubmitQcDate': '2024-04-08', 'lastUpdatePostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anaerobic power', 'timeFrame': 'one day every 30 minutes', 'description': 'Anaerobic power (anaerobic capacity) was determined twice (pre and post) dietary supplementation on one day. The anaerobic test was performed before supplemenation and 30 minutes after.'}, {'measure': 'aerobic power', 'timeFrame': 'one day every 30 minutes', 'description': 'Aerobic power (aerobic capacity) was determined twice (pre and post) dietary supplementation on one day. The anaerobic test was performed before supplemenation and 30 minutes after.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exercise', 'caffeine', 'muscle power'], 'conditions': ['Muscle Power']}, 'referencesModule': {'references': [{'pmid': '38853269', 'type': 'DERIVED', 'citation': 'Drwal A, Palka T, Tota L, Wiecha S, Cech P, Strzala M, Maciejczyk M. Acute effects of multi-ingredient pre-workout dietary supplement on anaerobic performance in untrained men: a randomized, crossover, single blind study. BMC Sports Sci Med Rehabil. 2024 Jun 9;16(1):128. doi: 10.1186/s13102-024-00918-1.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study was to determine the acute effects of multi-ingredient pre-workout supple-ment (MIPS) containing: beta-alanine, taurine, caffeine, L-tyrosine, and cayenne pepper (capsaicin) on physical performance in untrained men', 'detailedDescription': 'The aim of our study was to determine the acute effects of commercially available multi-ingredient pre-workout supple-ment (MIPS) containing: beta-alanine, taurine, caffeine, L-tyrosine, and cayenne pepper (capsai-cin) on physical performance in untrained men. The aerobic and anaerobic capacity was determined after ingestion of MIPS. A randomized, crossover, single-blind design was used to evaluate the effects of the dietary supplement on physical performance. The participants performed the exercise test twice, in random order: as a control test and after supplement administration (MIPS). The measurements took place over two consecutive days. Somatic measurements were taken on the same day that the first all-out test was performed. Twelve young healthy men, without medical contraindications to supramaximal and maximal intensity exercise, participated in the study. The exercise tests took place under medical supervision.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '19 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nlack of neuromuscular and musculoskeletal disorders; no medication nor dietary supplements used within the previous month which could potentially affect the study outcomes and self-described good health status. An additional inclusion criterion was the small amount of caffeine consumed per day, i.e. only one caffeinated coffee drink per day or less.\n\nExclusion Criteria:\n\nconsumption of energy drinks'}, 'identificationModule': {'nctId': 'NCT06363669', 'briefTitle': 'Effects of Caffeine-based Supplement on Physical Performance', 'organization': {'class': 'OTHER', 'fullName': 'University School of Physical Education, Krakow, Poland'}, 'officialTitle': 'Acute Effects of Multi-ingredient Pre-workout Dietary Supplement on Physical Performance in Untrained Men', 'orgStudyIdInfo': {'id': '1_CAF_AWF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'Group with placebo treatment (100 ml of orange-flavored water without any additional substances (0 kcal))'}, {'type': 'EXPERIMENTAL', 'label': 'group with MIPS supplementation', 'description': 'Group with supplementation. Supplement was commercially available and dispensed without a prescription. The dietary supplement contained in one dose (30ml): beta-alanine 3000 mg, taurine 1000 mg, caffeine 290 mg, L-tyrosine 125 mg, and cayenne pepper extract (Capsicum annuum L.) 4.2 mg (of which 8% capsaicin). The supplement was mixed with water; in total, participants were given 100 ml of liquid to drink, 30 minutes before the warm-up for the all-out anaerobic test.', 'interventionNames': ['Dietary Supplement: multi-ingredient pre-workout dietary supplement (caffeine-based)']}], 'interventions': [{'name': 'multi-ingredient pre-workout dietary supplement (caffeine-based)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The participants performed the exercise twice, in random order: as a control test and after supplement administration. The acute effects of MIPS supplementation (beta-alanine 3000 mg, taurine 1000 mg, caffeine 290 mg, L-tyrosine 125 mg, and cayenne pepper extract (Capsicum annuum L.) 4.2 mg (of which 8% capsaicin)) on aerobic and anaerobic performance were evaluated in untrained men', 'armGroupLabels': ['group with MIPS supplementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31-571', 'city': 'Krakow', 'country': 'Poland', 'facility': 'University School of Physical Education in Cracow', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}], 'overallOfficials': [{'name': 'Marcin Maciejczyk, prof.dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Physical Education, Kraków, Poland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University School of Physical Education, Krakow, Poland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}