Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:56 PM
Study NCT ID:
NCT04437758
Status:
COMPLETED
Last Update Posted:
2020-06-18
First Post:
2020-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Hydrolyzed Collagen and Vitamin C on Explosive 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003094', 'term': 'Collagen'}], 'ancestors': [{'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D016326', 'term': 'Extracellular Matrix Proteins'}, {'id': 'D012596', 'term': 'Scleroproteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "Sealed opaque packets coded by Sponsor's Product Development"}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-16', 'studyFirstSubmitDate': '2020-06-12', 'studyFirstSubmitQcDate': '2020-06-16', 'lastUpdatePostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Maximum peak force of maximal isometric squat (MIS)', 'timeFrame': '% change from baseline to week 1, week 2 and week 3', 'description': 'Peak force (N)'}, {'measure': 'Counter-movement jump (CMJ) net eccentric impulse', 'timeFrame': '% change from baseline to week 1, week 2 and week 3', 'description': 'Jump performance max N/s/kg (Note: Eccentric is the drop down part of the CMJ)'}, {'measure': 'Counter-movement jump (CMJ) net concentric impulse', 'timeFrame': '% change from baseline to week 1, week 2 and week 3', 'description': 'Jump performance max N/s/kg (Note: Concentric is the movement upwards of the CMJ)'}, {'measure': 'Leg stiffness assessment', 'timeFrame': '% change from baseline to week 1, week 2 and week 3', 'description': 'Tendon stiffness mean per kg (N/m/kg)'}], 'primaryOutcomes': [{'measure': 'Maximal rate of force development (RFD) of isometric squat (MIS)', 'timeFrame': '% change from baseline to week 1, week 2 and week 3', 'description': 'Force (N) over time (msec) for the maximum slope of the first 20% of the movement'}, {'measure': 'Counter-movement jump (CMJ) rate of force development (RFD)', 'timeFrame': '% change from baseline to week 1, week 2 and week 3', 'description': 'CMJ jump performance N/s/kg'}, {'measure': 'Squat jump height rate of force development (RFD)', 'timeFrame': '% change from baseline to week 1, week 2 and week 3', 'description': 'Squat jump height performance RFD/kg'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exercise', 'performance', 'athletes'], 'conditions': ['Collagen Synthesis', 'Rate of Force (RFD) Development']}, 'descriptionModule': {'briefSummary': 'Determine whether supplementation with a combined dose of 20 g of hydrolyzed collagen and 50 mg vitamin C, along with a power training exercise program, increases rate of force development (RFD) and performance in athletes'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Collagen synthesis varies significantly throughout the menstrual cycle in females. This natural variation would confound the study. Provided this work proves successful, we will aim to perform similar studies in females.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy male athletes between 18-30 years of age\n2. Currently participating in sport\n3. \\<3 musculoskeletal injuries in the past year\n4. No health or dietary restriction that would be affected by the supplementation protocol\n\nExclusion Criteria:\n\n1. History of more than 3 musculoskeletal injuries within the past 12 months\n2. Health, dietary restriction or diet that would be affected by the supplementation protocol\n3. Willing to eat similar dietary pattern the day before baseline testing and each exercise testing/intervention day'}, 'identificationModule': {'nctId': 'NCT04437758', 'briefTitle': 'Effects of Hydrolyzed Collagen and Vitamin C on Explosive Performance', 'organization': {'class': 'INDUSTRY', 'fullName': 'PepsiCo Global R&D'}, 'officialTitle': 'Effects of Hydrolyzed Collagen and Vitamin C on Explosive Performance', 'orgStudyIdInfo': {'id': 'PEP-1704'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hydrolyzed collagen and Vitamin C powder mix', 'description': '20 g hydrolyzed collagen + 50 mg vitamin C (ascorbic acid) pre-packed powder diluted in 250 ml (8 oz) of water', 'interventionNames': ['Dietary Supplement: Collagen and Vitamin C powder mix nutritional intervention', 'Other: Maximum power training exercise']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Maltodextrin powder', 'description': '20 g maltodextrin pre-packed powder diluted in 250 ml (8 oz) of water', 'interventionNames': ['Other: Maltodextrin placebo powder', 'Other: Maximum power training exercise']}], 'interventions': [{'name': 'Collagen and Vitamin C powder mix nutritional intervention', 'type': 'DIETARY_SUPPLEMENT', 'description': '20 g collagen + 50 mg vitamin C daily, 60 min prior to exercise', 'armGroupLabels': ['Hydrolyzed collagen and Vitamin C powder mix']}, {'name': 'Maltodextrin placebo powder', 'type': 'OTHER', 'description': '20 g maltodextrin placebo daily, 60 min prior to exercise', 'armGroupLabels': ['Maltodextrin powder']}, {'name': 'Maximum power training exercise', 'type': 'OTHER', 'description': 'Explosive/power-based exercise training program 3 times/week at home consisting of drop jumps, box jumps, weighted jump squats loaded in a progressive manner weekly for 3 weeks. At baseline and at the end of each of the 3 weeks, measures of explosive performance are assessed in the lab (maximal isometric squat, counter-movement jump and squat jump)', 'armGroupLabels': ['Hydrolyzed collagen and Vitamin C powder mix', 'Maltodextrin powder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95616', 'city': 'Davis', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Functional Molecular Biology Laboratory and Human Performance Laboratory', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}], 'overallOfficials': [{'name': 'Keith Baar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PepsiCo Global R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}