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

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

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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