NCT04967404

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Status
unknown

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

Completed
1 month until next milestone

Study Start

First participant enrolled

July 15, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 19, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2021

Completed
Last Updated

July 19, 2021

Status Verified

July 1, 2021

Enrollment Period

2 months

First QC Date

June 11, 2021

Last Update Submit

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

EXPERIMENTAL
Dietary Supplement: Phosphatidylserine

Maltodextrin, 800 mg per day, 10 days

PLACEBO COMPARATOR
Dietary Supplement: Phosphatidylserine

Interventions

PhosphatidylserineDIETARY_SUPPLEMENT

800 mg per day for 10 days

Maltodextrin, 800 mg per day, 10 daysPhosphatidylserine, 800 mg per day, 10 days

Eligibility Criteria

Age18 Years - 40 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsAll participants must be trained male cyclists
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Cyclists
  • Maximum oxygen uptake of at least 55 mL/kg/min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Phosphatidylserines

Intervention Hierarchy (Ancestors)

GlycerophospholipidsPhosphatidic AcidsGlycerophosphatesPhospholipidsMembrane LipidsLipids

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
Model Details: Participants matched on cycling time-trial performance and then randomly assigned to treatment or placebo groups
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