- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04967404
The Effect of Phosphatidylserine on Time Trial Performance in Trained Male Cyclists
July 8, 2021 updated by: Mark Glaister
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.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mark Glaister, PhD
- Phone Number: 02082404012
- Email: mark.glaister@stmarys.ac.uk
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Cyclists
- Maximum oxygen uptake of at least 55 mL/kg/min
Exclusion Criteria:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Phosphatidylserine, 800 mg per day, 10 days
|
800 mg per day for 10 days
|
|
Placebo Comparator: Maltodextrin, 800 mg per day, 10 days
|
800 mg per day for 10 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
30 minute cycling time-trial power output on an electromagnetically-braked cycle ergometer
Time Frame: From baseline to 11 days post supplementation
|
Mean power output
|
From baseline to 11 days post supplementation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oxygen consumption at four different exercise intensities (40, 50, 60 and 70% percent of maximal oxygen uptake) on an electromagnetically-braked cycle ergometer
Time Frame: From baseline to 11 days post supplementation
|
Evaluated using an online breath-by-breath gas analyser
|
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
Time Frame: From baseline to 11 days post supplementation
|
Evaluated using an online breath-by-breath gas analyser
|
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
Time Frame: From baseline to 11 days post supplementation
|
Evaluated using an online breath-by-breath gas analyser
|
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
Time Frame: From baseline to 11 days post supplementation
|
Evaluated using an online breath-by-breath gas analyser
|
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
Time Frame: From baseline to 11 days post supplementation
|
Obtained via capillary puncture and analysed using an automated analyser
|
From baseline to 11 days post supplementation
|
|
Blood glucose concentration at four different exercise intensities (40, 50, 60 and 70% percent of maximal oxygen uptake) on an electromagnetically-braked cycle ergometer
Time Frame: From baseline to 11 days post supplementation
|
Obtained via capillary puncture and analysed using an automated analyser
|
From baseline to 11 days post supplementation
|
|
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
Time Frame: From baseline to 11 days post supplementation
|
Evaluated using a 15-point (6-20) scale
|
From baseline to 11 days post supplementation
|
|
Heart rate at four different exercise intensities (40, 50, 60 and 70% percent of maximal oxygen uptake) on an electromagnetically-braked cycle ergometer
Time Frame: From baseline to 11 days post supplementation
|
Evaluated using a heart rate monitor
|
From baseline to 11 days post supplementation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 15, 2021
Primary Completion (Anticipated)
September 22, 2021
Study Completion (Anticipated)
September 22, 2021
Study Registration Dates
First Submitted
June 11, 2021
First Submitted That Met QC Criteria
July 8, 2021
First Posted (Actual)
July 19, 2021
Study Record Updates
Last Update Posted (Actual)
July 19, 2021
Last Update Submitted That Met QC Criteria
July 8, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- StMarysUC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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