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Exogenous Ketone Supplementation and Cognitive Function During Exercise

Primary Purpose

Ketonemia, Mental Fatigue, Ketosis

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
mental fatiguing task
45 - minute simulated soccer game
cognitive function
Sponsored by
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ketonemia focused on measuring Ketone supplements, Cognitive function, Exercise

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • In order to be eligible to participate in this study you must be a healthy male or female recreationally active individual, 18-35 year old.

Exclusion Criteria:

  • You will be excluded from this study if you:
  • Are not involved in regular exercise (at least 2x week)
  • Have symptoms or take medication for respiratory, cardiovascular, metabolic, neuromuscular disease
  • Use any medications with side effects of dizziness, lack of motor control, or slowed reaction time
  • Are taking part in another research study
  • For women, if you are pregnant or become pregnant during the study.
  • Have a history of concussion/head injuries.
  • Have an excessive alcohol intake (>2 drinks/day)
  • Are consuming a ketogenic diet (for at least 2 weeks)
  • Are a smoker
  • ** Cannabis use is not a exclusion criteria; however, it must be avoided on experimental days.**

Sites / Locations

  • Exercise Nutrition Laboratory, Western University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ketone esters

Placebo

Arm Description

Ketone esters will be given to mentally fatigued individuals, prior to a 45 minute simulated soccer game in which cognitive function will be assessed.

Iso-caloric carbohydrate drink will be given to mentally fatigued individuals, prior to a 45 minute simulated soccer game in which cognitive function will be assessed.

Outcomes

Primary Outcome Measures

Cognitive function
participants will be doing the Stroop test and a complex reaction test during exercise.

Secondary Outcome Measures

Blood Ketones
Ketones in blood will be measured using a ketone meter
Blood Glucose
blood glucose will be measured using a glucometer
Blood Lactate
blood lactate will be measured using a lactate meter

Full Information

First Posted
September 29, 2020
Last Updated
September 29, 2020
Sponsor
Western University, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT04576026
Brief Title
Exogenous Ketone Supplementation and Cognitive Function During Exercise
Official Title
Effect of Exogenous Ketone Supplementation on Cognitive Function During Exercise After Induced Mental Fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Anticipated)
Primary Completion Date
October 1, 2021 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western University, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
15 healthy trained males will volunteer to participate in this study. there will be 2 treatments: Ketone esters supplementation and iso-caloric carbohydrate. The purpose of this study is to evaluate the effect of ketone esters on cognitive function during exercise after induced mental fatigue
Detailed Description
mental fatigue is often seen in sports of moderate to long duration. its onset is associated with detriments in cognitive function which leads to poor decision making and detriments in specific sport skills. Ketones can serve as a powerful brain fuel source so they may have the potential to delay/ revert the onset of mental fatigue. in this experiment, we will induce mental fatigue in individuals who will be performing 45 minutes of intermittent exercise right after. During exercise cognitive function will be measured under 2 condition, Ketone supplementation and placebo. The purpose of this study is to see if ketones can play a role in reverting that initial mental fatigue during exercise, compared to placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ketonemia, Mental Fatigue, Ketosis
Keywords
Ketone supplements, Cognitive function, Exercise

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This will be a double blind repeated measures cross over study. There will be two treatments involved: Ketone esters supplements and iso-caloric carbohydrates (placebo). Participants will complete the protocol twice and the treatment order will be systematically rotated to avoid any order effect. Design of the study is composed of a mental fatiguing task, followed by a 45 minute simulated soccer game (second half). Cognitive function will be assessed during the 45 minutes of exercise. All participants will perform the protocol in a fed state (4 h after consumption of their last meal)
Masking
ParticipantInvestigator
Masking Description
Participants and investigators will be blinded as an individual not involved in the project will assemble and distribute the treatment (drinks) according to a coding system that is kept confidential until the study is completed. Participants will complete the protocol twice and the treatment order will be systematically rotated to avoid any order effect. taste and texture of treatments will be matched and will be distribute in opaque bottles to keep participant blinded
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketone esters
Arm Type
Experimental
Arm Description
Ketone esters will be given to mentally fatigued individuals, prior to a 45 minute simulated soccer game in which cognitive function will be assessed.
Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
Iso-caloric carbohydrate drink will be given to mentally fatigued individuals, prior to a 45 minute simulated soccer game in which cognitive function will be assessed.
Intervention Type
Behavioral
Intervention Name(s)
mental fatiguing task
Intervention Description
a 30-minute computerized Stroop test will be used to induce mental fatigue before exercise intervention
Intervention Type
Behavioral
Intervention Name(s)
45 - minute simulated soccer game
Intervention Description
an intermittent running protocol using intensities and speeds seen in soccer will be used to simulate the physiological demands of the sport
Intervention Type
Behavioral
Intervention Name(s)
cognitive function
Intervention Description
The Stroop test and a complex reaction time test will be used to assess cognitive function during exercise.
Primary Outcome Measure Information:
Title
Cognitive function
Description
participants will be doing the Stroop test and a complex reaction test during exercise.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Blood Ketones
Description
Ketones in blood will be measured using a ketone meter
Time Frame
45 minutes
Title
Blood Glucose
Description
blood glucose will be measured using a glucometer
Time Frame
45 minutes
Title
Blood Lactate
Description
blood lactate will be measured using a lactate meter
Time Frame
45 minutes

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: In order to be eligible to participate in this study you must be a healthy male or female recreationally active individual, 18-35 year old. Exclusion Criteria: You will be excluded from this study if you: Are not involved in regular exercise (at least 2x week) Have symptoms or take medication for respiratory, cardiovascular, metabolic, neuromuscular disease Use any medications with side effects of dizziness, lack of motor control, or slowed reaction time Are taking part in another research study For women, if you are pregnant or become pregnant during the study. Have a history of concussion/head injuries. Have an excessive alcohol intake (>2 drinks/day) Are consuming a ketogenic diet (for at least 2 weeks) Are a smoker ** Cannabis use is not a exclusion criteria; however, it must be avoided on experimental days.**
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter WR Lemon, PhD
Phone
519 6612111
Ext
88139
Email
plemon@uwo.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel Quinones, MSc
Phone
519 6612111
Ext
88139
Email
mquinon2@uwo.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter WR Lemon, PhD
Organizational Affiliation
Western University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Exercise Nutrition Laboratory, Western University
City
London
State/Province
Ontario
ZIP/Postal Code
N6A3K7
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter WR Lemon, PhD
Phone
5196612111
Ext
88139
Email
plemon@uwo.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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Exogenous Ketone Supplementation and Cognitive Function During Exercise

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