Exogenous Ketone Supplementation and Cognitive Function D... | NCT04576026

Studies
Exogenous Ketone Supplementation and Cognitive Function During Exercise

NCT04576026

Sponsor

Western University, Canada

Status

Unknown status

Last Update Posted

Oct 5, 2020Actual

Enrollment

15Estimated

Phase

Not Applicable

Conditions

Ketonemia
Mental Fatigue
Ketosis

Interventions

mental fatiguing task
45 - minute simulated soccer game
cognitive function

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2020Estimated

Primary Completion Date

Oct 1, 2021Estimated

Completion Date

Oct 1, 2021Estimated

First Submitted Date

Sep 29, 2020

First Submission Date that Met QC Criteria

Sep 29, 2020

First Posted Date

Oct 5, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2020

Last Update Posted Date

Oct 5, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
mental fatiguing task	Behavioral	a 30-minute computerized Stroop test will be used to induce mental fatigue before exercise intervention	Ketone esters Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.**

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Peter WR Lemon, PhD	Contact	519 6612111	88139	plemon@uwo.ca
Manuel Quinones, MSc	Contact	519 6612111	88139	mquinon2@uwo.ca

Overall Officials

Name	Affiliation	Role
Peter WR Lemon, PhD	Western University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Exercise Nutrition Laboratory, Western University		London	Ontario	N6A3K7	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007662	Ketosis
D005222	Mental Fatigue
D009043	Motor Activity

Ancestor Terms

ID	Term
D000138	Acidosis
D000137	Acid-Base Imbalance
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009483	Neuropsychological Tests

Ancestor Terms

ID	Term
D011581	Psychological Tests
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided

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)

Masking Info

Masking

Double

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

Who Masked

ParticipantInvestigator