Exogenous Ketone Supplementation and Cognitive Function During Exercise

NCT04576026 | Unknown

• 1 other identifier: 116711
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Ketonemia; Mental Fatigue; Ketosis

Keywords

Ketone supplements; Cognitive function; Exercise

Outcome Measures

Primary Outcomes (1)

• Cognitive function

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

  30 minutes

Secondary Outcomes (3)

• Blood Ketones

  45 minutes

• Blood Glucose

  45 minutes

• Blood Lactate

  45 minutes

Study Arms (2)

Ketone esters

EXPERIMENTAL

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; Behavioral: 45 - minute simulated soccer game; Behavioral: cognitive function

Placebo

ACTIVE COMPARATOR

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; Behavioral: 45 - minute simulated soccer game; Behavioral: cognitive function

Interventions

mental fatiguing task BEHAVIORAL

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

Ketone esters; Placebo

45 - minute simulated soccer game BEHAVIORAL

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

Ketone esters; Placebo

cognitive function BEHAVIORAL

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

Ketone esters; Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

Exercise Nutrition Laboratory, Western University

London, Ontario, N6A3K7, Canada

Location

MeSH Terms

Conditions

Ketosis; Mental Fatigue; Motor Activity

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Peter WR Lemon, PhD

  Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter WR Lemon, PhD

CONTACT

519 6612111; plemon@uwo.ca

Manuel Quinones, MSc

CONTACT

519 6612111; mquinon2@uwo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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)

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 5, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: October 5, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)