Exogenous Ketone Supplementation and Cognitive Function During Exercise

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

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

Study Overview

• Status: Unknown
• Conditions: Mental Fatigue; Ketosis; Ketonemia
• Intervention / Treatment: Behavioral: mental fatiguing task; Behavioral: 45 - minute simulated soccer game; Behavioral: cognitive function

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 Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A3K7
      • Exercise Nutrition Laboratory, Western University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.**

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive function	participants will be doing the Stroop test and a complex reaction test during exercise.	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Ketones	Ketones in blood will be measured using a ketone meter	45 minutes
Blood Glucose	blood glucose will be measured using a glucometer	45 minutes
Blood Lactate	blood lactate will be measured using a lactate meter	45 minutes

Collaborators and Investigators

• Sponsor: Western University, Canada

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: September 29, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: September 29, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Exercise; Cognitive function; Ketone supplements
• Additional Relevant MeSH Terms: Behavioral Symptoms; Metabolic Diseases; Acid-Base Imbalance; Acidosis; Fatigue; Ketosis; Mental Fatigue
• Other Study ID Numbers: 116711

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No