The Effect of Phosphatidylserine on Time Trial Performance in Trained Male Cyclists
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2021
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2021
CompletedStudy Start
First participant enrolled
July 15, 2021
CompletedFirst Posted
Study publicly available on registry
July 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 22, 2021
CompletedJuly 19, 2021
July 1, 2021
2 months
June 11, 2021
July 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
30 minute cycling time-trial power output on an electromagnetically-braked cycle ergometer
Mean power output
From baseline to 11 days post supplementation
Secondary Outcomes (8)
Oxygen consumption at four different exercise intensities (40, 50, 60 and 70% percent of maximal oxygen uptake) on an electromagnetically-braked cycle ergometer
From baseline to 11 days post supplementation
Respiratory exchange ratio at four different exercise intensities (40, 50, 60 and 70% percent of maximal oxygen uptake) on an electromagnetically-braked cycle ergometer
From baseline to 11 days post supplementation
Breathing frequency at four different exercise intensities (40, 50, 60 and 70% percent of maximal oxygen uptake) on an electromagnetically-braked cycle ergometer
From baseline to 11 days post supplementation
Minute ventilation at four different exercise intensities (40, 50, 60 and 70% percent of maximal oxygen uptake) on an electromagnetically-braked cycle ergometer
From baseline to 11 days post supplementation
Blood lactate concentration at four different exercise intensities (40, 50, 60 and 70% percent of maximal oxygen uptake) on an electromagnetically-braked cycle ergometer
From baseline to 11 days post supplementation
- +3 more secondary outcomes
Study Arms (2)
Phosphatidylserine, 800 mg per day, 10 days
EXPERIMENTALMaltodextrin, 800 mg per day, 10 days
PLACEBO COMPARATORInterventions
800 mg per day for 10 days
Eligibility Criteria
You may qualify if:
- Cyclists
- Maximum oxygen uptake of at least 55 mL/kg/min
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mark Glaisterlead
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The experiment will follow a double-blind design where all participants and investigators will be blinded to the treatments given.
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 11, 2021
First Posted
July 19, 2021
Study Start
July 15, 2021
Primary Completion
September 22, 2021
Study Completion
September 22, 2021
Last Updated
July 19, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share