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出境医 / 临床实验 / The Effect of Phosphatidylserine on Time Trial Performance in Trained Male Cyclists

The Effect of Phosphatidylserine on Time Trial Performance in Trained Male Cyclists

Study Description
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.

Condition or disease Intervention/treatment Phase
The Focus of the Study is to Investigate the Effects of Phosphatidylserine Supplementation on Exercise Physiology and Cycling Time-trial Performance Dietary Supplement: Phosphatidylserine Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants matched on cycling time-trial performance and then randomly assigned to treatment or placebo groups
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The experiment will follow a double-blind design where all participants and investigators will be blinded to the treatments given.
Primary Purpose: Basic Science
Official Title: The Effect of Phosphatidylserine on Time Trial Performance in Trained Male Cyclists
Estimated Study Start Date : July 15, 2021
Estimated Primary Completion Date : September 22, 2021
Estimated Study Completion Date : September 22, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Phosphatidylserine, 800 mg per day, 10 days Dietary Supplement: Phosphatidylserine
800 mg per day for 10 days
Placebo Comparator: Maltodextrin, 800 mg per day, 10 days Dietary Supplement: Phosphatidylserine
800 mg per day for 10 days
Outcome Measures
Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   All participants must be trained male cyclists
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Contacts
Layout table for location contacts
Contact: Mark Glaister, PhD 02082404012 mark.glaister@stmarys.ac.uk

Sponsors and Collaborators
Mark Glaister
Tracking Information
First Submitted Date  ICMJE June 11, 2021
First Posted Date  ICMJE July 19, 2021
Last Update Posted Date July 19, 2021
Estimated Study Start Date  ICMJE July 15, 2021
Estimated Primary Completion Date September 22, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2021) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2021)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Phosphatidylserine on Time Trial Performance in Trained Male Cyclists
Official Title  ICMJE The Effect of Phosphatidylserine on Time Trial Performance in Trained Male Cyclists
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants matched on cycling time-trial performance and then randomly assigned to treatment or placebo groups
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The experiment will follow a double-blind design where all participants and investigators will be blinded to the treatments given.
Primary Purpose: Basic Science
Condition  ICMJE The Focus of the Study is to Investigate the Effects of Phosphatidylserine Supplementation on Exercise Physiology and Cycling Time-trial Performance
Intervention  ICMJE Dietary Supplement: Phosphatidylserine
800 mg per day for 10 days
Study Arms  ICMJE
  • Experimental: Phosphatidylserine, 800 mg per day, 10 days
    Intervention: Dietary Supplement: Phosphatidylserine
  • Placebo Comparator: Maltodextrin, 800 mg per day, 10 days
    Intervention: Dietary Supplement: Phosphatidylserine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2021) 		20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 22, 2021
Estimated Primary Completion Date September 22, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: All participants must be trained male cyclists
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Mark Glaister, PhD 02082404012 mark.glaister@stmarys.ac.uk
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04967404
Other Study ID Numbers  ICMJE StMarysUC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mark Glaister, St Mary's University College
Study Sponsor  ICMJE Mark Glaister
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account St Mary's University College
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP