Exogenous Ketone Supplementation and Cognitive Function During Exercise

Ketosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04576026
• Other study ID #: 116711
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: September 2020
• Source: Western University, Canada
• Contact: Peter WR Lemon, PhD
• Phone: 519 6612111
• Email: plemon[@]uwo.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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.**

Related Conditions & MeSH terms

• Fatigue
• Ketonemia
• Ketosis
• Mental Fatigue

Intervention

Behavioral:
• mental fatiguing task
a 30-minute computerized Stroop test will be used to induce mental fatigue before exercise intervention
• 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
• cognitive function
The Stroop test and a complex reaction time test will be used to assess cognitive function during exercise.

Locations

Country	Name	City	State
Canada	Exercise Nutrition Laboratory, Western University	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive function	participants will be doing the Stroop test and a complex reaction test during exercise.	30 minutes
Secondary	Blood Ketones	Ketones in blood will be measured using a ketone meter	45 minutes
Secondary	Blood Glucose	blood glucose will be measured using a glucometer	45 minutes
Secondary	Blood Lactate	blood lactate will be measured using a lactate meter	45 minutes