The Focus of the Study is to Investigate the Effects of Phosphatidylserine Supplementation on Exercise Physiology and Cycling Time-trial PerformanceNCT04967404
The Effect of Phosphatidylserine on Time Trial Performance in Trained Male Cyclists
A study testing Phosphatidylserine in people with The Focus of the Study is to Investigate the Effects of Phosphatidylserine Supplementation on Exercise Physiology and Cycling Time-trial Performance, run by Mark Glaister.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- The Focus of the Study is to Investigate the Effects of Phosphatidylserine Supplementation on Exercise Physiology and Cycling Time-trial Performance
- What is being tested?
- Phosphatidylserine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2021to 22 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Cyclists
- Maximum oxygen uptake of at least 55 mL/kg/min
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Being tested
- Phosphatidylserine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhosphatidylserineDietary supplement
800 mg per day for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Phosphatidylserine, 800 mg per day, 10 days | Experimental | Not described Receives: Dietary Supplement: Phosphatidylserine |
| Maltodextrin, 800 mg per day, 10 days | Placebo comparator | Not described Receives: Dietary Supplement: Phosphatidylserine |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 minute cycling time-trial power output on an electromagnetically-braked cycle ergometer
Mean power output
Measured: 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
Evaluated using an online breath-by-breath gas analyser
Measured: 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
Evaluated using an online breath-by-breath gas analyser
Measured: 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
Evaluated using an online breath-by-breath gas analyser
Measured: 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
Evaluated using an online breath-by-breath gas analyser
Measured: 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
Obtained via capillary puncture and analysed using an automated analyser
Measured: 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
Obtained via capillary puncture and analysed using an automated analyser
Measured: 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
Evaluated using a 15-point (6-20) scale
Measured: 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
Evaluated using a heart rate monitor
Measured: From baseline to 11 days post supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start15 Jul 2021 (estimated)
- Primary completion22 Sep 2021 (estimated)
- Study completion22 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Focus of the Study is to Investigate the Effects of Phosphatidylserine Supplementation on Exercise Physiology and Cycling Time-trial PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants matched on cycling time-trial performance and then randomly assigned to treatment or placebo groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mark Glaister
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mark Glaister, St Mary's University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967404
- Sponsor's protocol ID
- StMarysUC
- Status last verified
- Jul 2021
- First submitted
- 11 Jun 2021
- Last updated
- 19 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Phosphatidylserine on Time Trial Performance in Trained Male Cyclists
- ClinicalTrials.gov ID
- NCT04967404
- Acronym / sponsor ID
- StMarysUC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mark GlaisterUniversity, hospital or other
- Study start
- 15 Jul 2021 (estimated)
- Primary completion
- 22 Sep 2021 (estimated)
- Study completion
- 22 Sep 2021 (estimated)
- First posted
- 19 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants matched on cycling time-trial performance and then randomly assigned to treatment or placebo groups
| Arm | Type | Receives |
|---|---|---|
| Phosphatidylserine, 800 mg per day, 10 days | Experimental | Dietary Supplement: Phosphatidylserine |
| Maltodextrin, 800 mg per day, 10 days | Placebo comparator | Dietary Supplement: Phosphatidylserine |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Cyclists
- Maximum oxygen uptake of at least 55 mL/kg/min
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phosphatidylserine800 mg per day for 10 days | Dietary supplement | Maltodextrin, 800 mg per day, 10 days, Phosphatidylserine, 800 mg per day, 10 days |
Primary outcome
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
8 secondary outcomes
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
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
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Phosphatidylserine in people with The Focus of the Study is to Investigate the Effects of Phosphatidylserine Supplementation on Exercise Physiology and Cycling Time-trial Performance, run by Mark Glaister.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Glaister, PhD (02082404012, mark.glaister@stmarys.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 minute cycling time-trial power output on an electromagnetically-braked cycle ergometer (time frame: From baseline to 11 days post supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2021.