Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-02 @ 10:35 AM
Study NCT ID:
NCT04967404
Status:
UNKNOWN
Last Update Posted:
2021-07-19
First Post:
2021-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Phosphatidylserine on Time Trial Performance in Trained Male Cyclists
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010718', 'term': 'Phosphatidylserines'}], 'ancestors': [{'id': 'D020404', 'term': 'Glycerophospholipids'}, {'id': 'D010712', 'term': 'Phosphatidic Acids'}, {'id': 'D005994', 'term': 'Glycerophosphates'}, {'id': 'D010743', 'term': 'Phospholipids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The experiment will follow a double-blind design where all participants and investigators will be blinded to the treatments given.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants matched on cycling time-trial performance and then randomly assigned to treatment or placebo groups'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-09-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-08', 'studyFirstSubmitDate': '2021-06-11', 'studyFirstSubmitQcDate': '2021-07-08', 'lastUpdatePostDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30 minute cycling time-trial power output on an electromagnetically-braked cycle ergometer', 'timeFrame': 'From baseline to 11 days post supplementation', 'description': 'Mean power output'}], 'secondaryOutcomes': [{'measure': 'Oxygen consumption at four different exercise intensities (40, 50, 60 and 70% percent of maximal oxygen uptake) on an electromagnetically-braked cycle ergometer', 'timeFrame': 'From baseline to 11 days post supplementation', 'description': 'Evaluated using an online breath-by-breath gas analyser'}, {'measure': 'Respiratory exchange ratio at four different exercise intensities (40, 50, 60 and 70% percent of maximal oxygen uptake) on an electromagnetically-braked cycle ergometer', 'timeFrame': 'From baseline to 11 days post supplementation', 'description': 'Evaluated using an online breath-by-breath gas analyser'}, {'measure': 'Breathing frequency at four different exercise intensities (40, 50, 60 and 70% percent of maximal oxygen uptake) on an electromagnetically-braked cycle ergometer', 'timeFrame': 'From baseline to 11 days post supplementation', 'description': 'Evaluated using an online breath-by-breath gas analyser'}, {'measure': 'Minute ventilation at four different exercise intensities (40, 50, 60 and 70% percent of maximal oxygen uptake) on an electromagnetically-braked cycle ergometer', 'timeFrame': 'From baseline to 11 days post supplementation', 'description': 'Evaluated using an online breath-by-breath gas analyser'}, {'measure': 'Blood lactate concentration at four different exercise intensities (40, 50, 60 and 70% percent of maximal oxygen uptake) on an electromagnetically-braked cycle ergometer', 'timeFrame': 'From baseline to 11 days post supplementation', 'description': 'Obtained via capillary puncture and analysed using an automated analyser'}, {'measure': 'Blood glucose concentration at four different exercise intensities (40, 50, 60 and 70% percent of maximal oxygen uptake) on an electromagnetically-braked cycle ergometer', 'timeFrame': 'From baseline to 11 days post supplementation', 'description': 'Obtained via capillary puncture and analysed using an automated analyser'}, {'measure': 'Rating of perceived exertion at four different exercise intensities (40, 50, 60 and 70% percent of maximal oxygen uptake) on an electromagnetically-braked cycle ergometer', 'timeFrame': 'From baseline to 11 days post supplementation', 'description': 'Evaluated using a 15-point (6-20) scale'}, {'measure': 'Heart rate at four different exercise intensities (40, 50, 60 and 70% percent of maximal oxygen uptake) on an electromagnetically-braked cycle ergometer', 'timeFrame': 'From baseline to 11 days post supplementation', 'description': 'Evaluated using a heart rate monitor'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['The Focus of the Study is to Investigate the Effects of Phosphatidylserine Supplementation on Exercise Physiology and Cycling Time-trial Performance']}, 'descriptionModule': {'briefSummary': 'Phosphatidylserine is a phospholipid found in high concentrations in the brain and nervous tissues along with naturally occurring in many foods. It has been extensively studied for its effects on improving cognitive function, learning, memory and alleviating stress. However, more recently it has been proposed that phosphatidylserine could improve exercise capacity. The mechanisms of proposed action are difficult to distinguish because of the limited research and therefore the purpose of this study is to identify the proposed mechanism of action of phosphatidylserine supplementation and to establish whether these mechanisms will have an effect on time trial performance in trained male cyclists.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'All participants must be trained male cyclists', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cyclists\n* Maximum oxygen uptake of at least 55 mL/kg/min\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT04967404', 'briefTitle': 'The Effect of Phosphatidylserine on Time Trial Performance in Trained Male Cyclists', 'organization': {'class': 'OTHER', 'fullName': "St Mary's University College"}, 'officialTitle': 'The Effect of Phosphatidylserine on Time Trial Performance in Trained Male Cyclists', 'orgStudyIdInfo': {'id': 'StMarysUC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phosphatidylserine, 800 mg per day, 10 days', 'interventionNames': ['Dietary Supplement: Phosphatidylserine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Maltodextrin, 800 mg per day, 10 days', 'interventionNames': ['Dietary Supplement: Phosphatidylserine']}], 'interventions': [{'name': 'Phosphatidylserine', 'type': 'DIETARY_SUPPLEMENT', 'description': '800 mg per day for 10 days', 'armGroupLabels': ['Maltodextrin, 800 mg per day, 10 days', 'Phosphatidylserine, 800 mg per day, 10 days']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mark Glaister, PhD', 'role': 'CONTACT', 'email': 'mark.glaister@stmarys.ac.uk', 'phone': '02082404012'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mark Glaister', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mark Glaister', 'investigatorAffiliation': "St Mary's University College"}}}}