Clinical trial NCT04576026: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Ketonemia
Mental Fatigue
Ketosis
Keywords: Ketone supplements
Cognitive function
Exercise
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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)
Primary purpose: OTHER

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.

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.\*\*

Primary outcomes:
measure: Cognitive function
timeFrame: 30 minutes
Secondary outcomes:
measure: Blood Ketones
timeFrame: 45 minutes
measure: Blood Glucose
timeFrame: 45 minutes
measure: Blood Lactate
timeFrame: 45 minutes
Other outcomes:
Locations:
city: London
country: Canada
facility: Exercise Nutrition Laboratory, Western University
state: Ontario
Study officials:
affiliation: Western University
name: Peter WR Lemon, PhD
role: PRINCIPAL_INVESTIGATOR
References: