Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-28 @ 8:31 AM
Study NCT ID:
NCT05230303
Status:
COMPLETED
Last Update Posted:
2023-03-10
First Post:
2022-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Caffeine Supplementation, Resistance Training and Blood Antioxidant Status
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-08', 'studyFirstSubmitDate': '2022-01-14', 'studyFirstSubmitQcDate': '2022-01-28', 'lastUpdatePostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change the levels of oxidative stress markers', 'timeFrame': 'Day 1, Day 2', 'description': 'Serum will be obtained for TOS/TOC (total oxidative stress), MDA (malondialdehyde), oncentration of TAS (total antioxidant status), activity of superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPx); concentartion of GSH (reduced glutathione) and UA (uric acid)'}, {'measure': 'Changes in markers of muscle damage', 'timeFrame': 'Day 1, Day 2', 'description': 'Serum will be obtained for activity of creatine kinase (CK) and lactate dehydrogenase (LDH), concentration of myoglobin (Mb)'}, {'measure': 'Changes in Inflammation markers', 'timeFrame': 'Day 1, Day 2', 'description': 'Serum will be obtained for level of interleukin 6, TNF alfa (tumor matrix factor), CRP (C-reactive protein)'}, {'measure': 'Changes in markers of liver function', 'timeFrame': 'Day 1, Day 2', 'description': 'Serum will be obtained for activity of ASPAT (aspartate aminotransferase), ALAT (alanine aminotransferase) and gamma glutamyltransferase (GGT)'}], 'secondaryOutcomes': [{'measure': 'Changes in resistance training volume', 'timeFrame': 'During caffeine and placebo treatment'}, {'measure': 'Changes in rate of perceived exertion after resistance training', 'timeFrame': 'Immediately after exercise protocol during caffeine and placebo treatment'}, {'measure': 'Changes in heart rate during resistance training', 'timeFrame': 'During caffeine and placebo treatment'}, {'measure': 'Changes in muscle soreness', 'timeFrame': 'prior to exercise, and 24, 48, 72, 96 and 120 hours post exercise.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sports performance, resistance training, nutrition, athlete'], 'conditions': ['Caffeine']}, 'referencesModule': {'references': [{'pmid': '37711718', 'type': 'DERIVED', 'citation': 'Filip-Stachnik A, Krzysztofik M, Del Coso J, Palka T, Sadowska-Krepa E. The Effect of Acute Caffeine Intake on Resistance Training Volume, Prooxidant-Antioxidant Balance and Muscle Damage Markers Following a Session of Full-Body Resistance Exercise in Resistance-Trained Men Habituated to Caffeine. J Sports Sci Med. 2023 Sep 1;22(3):436-446. doi: 10.52082/jssm.2023.436. eCollection 2023 Sep.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to verify the effect of acute caffeine intake on resistance training volume and blood antioxidant status, in a randomised, double-blind, placebo-controlled crossover trial.', 'detailedDescription': 'Caffeine is one of the most commonly consumed psychoactive substances in the world. Several previous studies confirmed that caffeine improves several aspects of exercise performance, including resistance training outcomes. Interestingly, caffeine and its catabolic products, theobromine and xanthine, exhibit antioxidant and prooxidant properties. Additionally, resistance training promotes the generation of reactive oxygen species, which are important for the cellular adaptation process.\n\nHovewer, to the best of our knowledge, there is no information as to how caffeine combined with resistance training affects blood antioxidant status. Therefore, the aim of this study was to examine acute effects of caffeine supplementation on resistance training volume and blood antioxidant status in resistance trained men.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* written consent to participate,\n* medical permission by physician\n* "resistance-trained," defined as having a minimum of two years of resistance training experience\n* minimum of 2 workout sessions per week in the last 6 months\n\nExclusion Criteria:\n\n* neuromuscular or musculoskeletal disorders\n* current injury\n* using any medications, dietary supplements or ergogenic aids which could potentially affect the study outcomes\n* a positive smoking status\n* potential allergy to caffeine'}, 'identificationModule': {'nctId': 'NCT05230303', 'briefTitle': 'Caffeine Supplementation, Resistance Training and Blood Antioxidant Status', 'organization': {'class': 'OTHER', 'fullName': 'The Jerzy Kukuczka Academy of Physical Education in Katowice'}, 'officialTitle': 'Acute Effects of Caffeine Supplementation on Resistance Training Volume and Blood Antioxidant Status in Resitance Trained Men', 'orgStudyIdInfo': {'id': '01_2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Caffeine supplementation', 'description': 'Group taking 3 mg/kg of caffeine', 'interventionNames': ['Dietary Supplement: Caffeine supplementation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo treatment', 'description': 'Group taking placebo', 'interventionNames': ['Dietary Supplement: Placebo treatment']}], 'interventions': [{'name': 'Caffeine supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Two identical experimental sessions with a one-week interval between sessions (to allow complete recovery and ensure substance wash-out) will be taken. During the experimental sessions, participants will ingest caffeine in dose of 3 mg/kg of body mass. Caffeine will be provided in capsules containing the individual amount of caffeine and will be administered orally 60 min before the onset of the exercise protocol.', 'armGroupLabels': ['Caffeine supplementation']}, {'name': 'Placebo treatment', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The experimental procedure for each particpant will include placebo supplementation. The manufacturer of the caffeine capsules will also prepare identical placebo capsules filled out with a microcrystalline cellulose. Placebo will be administered orally 60 min before the onset of the exercise protocol.', 'armGroupLabels': ['Placebo treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40-065', 'city': 'Katowice', 'country': 'Poland', 'facility': 'The Jerzy Kukuczka Academy of Physical Education', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}], 'overallOfficials': [{'name': 'Adam Zając, Profesor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We do not plan to share IPD.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Jerzy Kukuczka Academy of Physical Education in Katowice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Aleksandra Filip-Stachnik', 'investigatorAffiliation': 'The Jerzy Kukuczka Academy of Physical Education in Katowice'}}}}