Exogenous Ketone Supplementation and Cognitive Function During Exercise

Sponsor

Western University, Canada (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04576026

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Ketonemia Mental Fatigue Ketosis	Behavioral: mental fatiguing task Behavioral: 45 - minute simulated soccer game Behavioral: cognitive function	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention 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)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:

Double (Participant, Investigator)

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

Primary Purpose:

Other

Official Title:

Effect of Exogenous Ketone Supplementation on Cognitive Function During Exercise After Induced Mental Fatigue

Anticipated Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ketone esters Ketone esters will be given to mentally fatigued individuals, prior to a 45 minute simulated soccer game in which cognitive function will be assessed.	Behavioral: mental fatiguing task a 30-minute computerized Stroop test will be used to induce mental fatigue before exercise intervention Behavioral: 45 - minute simulated soccer game an intermittent running protocol using intensities and speeds seen in soccer will be used to simulate the physiological demands of the sport Behavioral: cognitive function The Stroop test and a complex reaction time test will be used to assess cognitive function during exercise.
Active Comparator: Placebo 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.	Behavioral: mental fatiguing task a 30-minute computerized Stroop test will be used to induce mental fatigue before exercise intervention Behavioral: 45 - minute simulated soccer game an intermittent running protocol using intensities and speeds seen in soccer will be used to simulate the physiological demands of the sport Behavioral: cognitive function The Stroop test and a complex reaction time test will be used to assess cognitive function during exercise.

Arm

Intervention/Treatment

Experimental: Ketone esters

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

Behavioral: mental fatiguing task

a 30-minute computerized Stroop test will be used to induce mental fatigue before exercise intervention

Behavioral: 45 - minute simulated soccer game

an intermittent running protocol using intensities and speeds seen in soccer will be used to simulate the physiological demands of the sport

Behavioral: cognitive function

The Stroop test and a complex reaction time test will be used to assess cognitive function during exercise.

Active Comparator: Placebo

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.

Behavioral: mental fatiguing task

a 30-minute computerized Stroop test will be used to induce mental fatigue before exercise intervention

Behavioral: 45 - minute simulated soccer game

an intermittent running protocol using intensities and speeds seen in soccer will be used to simulate the physiological demands of the sport

Behavioral: cognitive function

The Stroop test and a complex reaction time test will be used to assess cognitive function during exercise.

Outcome Measures

Primary Outcome Measures

Cognitive function [30 minutes]
participants will be doing the Stroop test and a complex reaction test during exercise.

Secondary Outcome Measures

Blood Ketones [45 minutes]
Ketones in blood will be measured using a ketone meter
Blood Glucose [45 minutes]
blood glucose will be measured using a glucometer
Blood Lactate [45 minutes]
blood lactate will be measured using a lactate meter

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.**