Ignite Creation Date:
2025-12-26 @ 10:33 AM
Ignite Modification Date:
2025-12-29 @ 10:20 AM
Study NCT ID:
NCT05127928
Status:
COMPLETED
Last Update Posted:
2022-04-07
First Post:
2021-06-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antioxidants Vitamins and Muscle Damage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014810', 'term': 'Vitamin E'}, {'id': 'D001205', 'term': 'Ascorbic Acid'}, {'id': 'D024505', 'term': 'Tocopherols'}], 'ancestors': [{'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-03-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-04', 'studyFirstSubmitDate': '2021-06-15', 'studyFirstSubmitQcDate': '2021-11-08', 'lastUpdatePostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of body fat and muscle mass', 'timeFrame': 'Prior to the intervention', 'description': 'Determination of body composition using skinfolds measurements'}, {'measure': 'DOMS', 'timeFrame': '0 hours post exercise', 'description': 'Delayed onset muscle soreness. This outcome will be measure with a 10-point visual analogic scale (0= no pain; 10 = worst possible pain)'}, {'measure': 'DOMS', 'timeFrame': '24 hours post exercise', 'description': 'Delayed onset muscle soreness. This outcome will be measure with a 10-point visual analogic scale (0= no pain; 10 = worst possible pain)'}, {'measure': 'Blood malondialdehyde (MDA)', 'timeFrame': '2 hours prior to exercise', 'description': 'MDA will be analyzed from a blood sample'}, {'measure': 'Blood creatine quinase (CK)', 'timeFrame': '2 hours prior to exercise', 'description': 'CK will be analyzed from a blood sample'}, {'measure': 'Blood malondialdehyde (MDA)', 'timeFrame': 'Inmediatly after exercise', 'description': 'MDA will be analyzed from a blood sample'}, {'measure': 'Blood malondialdehyde (MDA)', 'timeFrame': '24 hours after exercise', 'description': 'MDA will be analyzed from a blood sample'}, {'measure': 'Blood creatine quinase (CK)', 'timeFrame': '24 hours after exercise', 'description': 'CK will be analyzed from a blood sample'}, {'measure': 'Jump height in a Counter Movement Jump', 'timeFrame': '2 hours prior to exercise', 'description': 'Jump height (cm) in a counter movement jump measured with Octojump Platform'}, {'measure': 'Jump height in a Counter Movement Jump', 'timeFrame': 'Inmediatly after exercise', 'description': 'Jump height (cm) in a counter movement jump measured with Octojump Platform'}, {'measure': 'Jump height in a Counter Movement Jump', 'timeFrame': '24 h after exercise', 'description': 'Jump height (cm) in a counter movement jump measured with Octojump Platform'}, {'measure': 'Jump Height in a Squat Jump', 'timeFrame': '24 h after exercise', 'description': 'Jump Height (cm) in a Squat Jump measured with Octojump Platform'}, {'measure': 'Jump Height in a Squat Jump', 'timeFrame': 'Inmediately after exercise', 'description': 'Jump Height (cm) in a Squat Jump measured with Octojump Platform'}, {'measure': 'Jump Height in a squat Jump', 'timeFrame': '2 hours prior to exercise', 'description': 'Jump height (cm) in a squat jump with Octojump Platform measured with Octojump Platform'}, {'measure': 'Jump Height in a Drop Jump', 'timeFrame': '2 hours prior to exercise', 'description': 'Jump height (cm) was measured in different drop jumps with Octojump Platform'}, {'measure': 'Jump Height in a Drop Jump', 'timeFrame': 'Inmediately after exercise', 'description': 'Jump height (cm) was measured in different drop jumps with Octojump Platform'}, {'measure': 'Contact time in a Drop Jump', 'timeFrame': 'Inmediately after exercise', 'description': 'Contact time (s)measured in different drop jumps with Octojump Platform'}, {'measure': 'Jump Height in a Drop Jump', 'timeFrame': 'Inmediately after exercise', 'description': 'Jump height (cm) measured in different drop jumps with Octojump Platform'}, {'measure': 'Contact time in a Drop Jump', 'timeFrame': '24 hours after exercise', 'description': 'Contact time (s) measured in different drop jumps with Octojump Platform'}, {'measure': 'Jump Height in a Drop Jump', 'timeFrame': '24 hours after exercise', 'description': 'Jump height (cm) measured in different drop jumps with Octojump Platform'}, {'measure': 'Contact time in a Drop Jump', 'timeFrame': 'Inmediately after exercise', 'description': 'Capillary blood lactate evaluated with Lactate Pro 2'}, {'measure': 'Concentration of blood lactate', 'timeFrame': '2 hours before exercise', 'description': 'Capillary blood lactate with Lactate Pro 2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['antioxidant vitamins', 'oxidative damage'], 'conditions': ['Oxidative Stress']}, 'descriptionModule': {'briefSummary': 'Determine if acute supplementation with antioxidant vitamins (vitamin C and vitamin E) influences the muscle damage and fatigue caused after an acute session of eccentric training.', 'detailedDescription': 'A randomized, single-blind, placebo-control parallel trial will be conducted. In a previous session volunteers will be interviewed to determine if they meet the inclusion criteria.\n\nParticipants should avoid ingesting of foods that contain high amounts of antioxidant compounds: more than two juices of fruits, more than four cups of coffee or tea. Juices with high antioxidant content should be avoided. Alcoholic beverages should also be avoided. Participants will be divided in to groups and will performance one resistance exercise sessions. Prior to exercise, one group will intake supplementation VitC (1000 mg) + VitE (235 mg) and the other supplementation with placebo.\n\nThe following sequence will be performed in each session: 1) baseline assessment (analysis of the composition body, blood draw and parameters of performance) prior to exercise session ; 2) administration of vitamin or placebo supplementation 2 hours before exercise session ; 3) post-exercise assessments (blood biomarkers and performance parameters) immediately after the session and after 24 hours. DOMS will also be assessed 48 h and 72 h after training. The training session implemented will be designed by a Sport Scientific'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '33 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Physically active\n\nExclusion Criteria:\n\n* Injuries\n* Supplementation or drugs\n* Smokers'}, 'identificationModule': {'nctId': 'NCT05127928', 'acronym': 'Antioxidant', 'briefTitle': 'Antioxidants Vitamins and Muscle Damage', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Europea de Madrid'}, 'officialTitle': 'Antioxidants Vitamins and Muscle Damage', 'orgStudyIdInfo': {'id': 'CIPI/20/209-part2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supplementation', 'description': 'Vitamin C and Vitamin E before exercise', 'interventionNames': ['Dietary Supplement: Dietary Supplement: Vitamin C and vitamin E']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo before exercise', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Dietary Supplement: Vitamin C and vitamin E', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Ascorbic acid and tocopherol'], 'description': 'Antioxidant supplementation', 'armGroupLabels': ['Supplementation']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo administration', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Madrid', 'country': 'Spain', 'facility': 'Universidad Europea de Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Europea de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD student, principal investigator', 'investigatorFullName': 'María Martínez Ferrán', 'investigatorAffiliation': 'Universidad Europea de Madrid'}}}}