Exogenous Ketone Supplementation and Exercise Performance

NCT ID: NCT03895892

Last Updated: 2019-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-15

Study Completion Date

2019-12-31

Brief Summary

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20 healthy recreationally active men and woman aged 18-35 will participate in the study. There will be three treatments involved: Caffeinated ketone supplements, non-caffeinated ketone supplement and water-placebo. Participants will complete the protocol three times and the treatment order will be systematically rotated to avoid any order effect. The three main trials will be separated by at least 1 week. After providing the corresponding treatment, participants will be given 30 minutes and after, they will perform a standardized 10-minute warm-up, followed by the 20 km time trial and a 30-second all-out Wingate test.

Detailed Description

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Some researchers support that a state of ketosis, reached through the use of ketogenic diet, has the potential to improve athletic. To attain such state, individuals must restrict carbohydrate intake to a maximum of 50g/ day or 10% while keeping protein intake moderate. One of the biggest challenges to achieve and maintain ketosis is complying with the diet due to its restrictive nature. Consequently, manufacturers have developed supplements that can induce a state of ketosis acutely (\~1 hour). Unfortunately, there is very little evidence supporting the use of these supplements to enhance athletic performance. Hyperketonemia (blood ketone concentration \> 0.2 Mm) seems to elevate the rate of utilization of ketone bodies. These changes in substrate utilization may allow athletes to preserve, something that would be advantageous for exercise performance. Ketone salts have been shown to elevate the concentration of ketones in blood and as such they may allow the body benefit from the apparent sparing of carbohydrates. Manufacturers now provide ketones salts combined with other ingredients such as caffeine. However it is unknown whether or not the addition of these ingredients has any positive or negative effect on athletic performance. Caffeine alone has been shown to improve athletic performance in several studies. Therefore, the purpose of this study is to compare the effectiveness of a caffeine free ketone salt supplement vs a caffeinated ketone salt supplement and their effects on a 20km time trial and a 30 second all-out Wingate test.

Conditions

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Ketonemia Ketosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This will be a double blind repeated measures cross over study. There will be three treatments involved: Caffeinated ketone supplements, non-caffeinated ketone supplement and water-placebo. Participants will complete the protocol three times and the treatment order will be systematically rotated to avoid any order effect. Design of the study is composed of two performance tests 30 minutes following supplementation. All participants will arrive in a fed state to the laboratory. the corresponding treatment will be provided and 30 minutes later, they will perform a 20 km time trial. 10 minutes after the time trial, participants will perform a 30 second all-out Wingate test.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
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 three times 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

Study Groups

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Water Placebo

Placebo flavored drink similar to treatments but with no energy will be ingested before completing a 20km Time trial and a 30 second all-out Wingate test

Group Type PLACEBO_COMPARATOR

20 km time trial

Intervention Type BEHAVIORAL

20 km time trial cycling test will be conducted to measure the effect of different drinks on time

Wingate test

Intervention Type BEHAVIORAL

30 second all-out effort on a bike will be conducted to measure the effect of different drinks on peak power output

Water Placebo

Intervention Type DIETARY_SUPPLEMENT

Dietary supplement containing only water

Experimental 1

Ketone salts supplement mixed in water will be ingested before completing a 20km Time trial and a 30 second all-out Wingate test

Group Type EXPERIMENTAL

20 km time trial

Intervention Type BEHAVIORAL

20 km time trial cycling test will be conducted to measure the effect of different drinks on time

Wingate test

Intervention Type BEHAVIORAL

30 second all-out effort on a bike will be conducted to measure the effect of different drinks on peak power output

Ketone

Intervention Type DIETARY_SUPPLEMENT

Dietary supplement containing only ketone salts

Experimental 2

Ketone salts/caffeine supplement mixed in water will be ingested before completing a 20km Time trial and a 30 second all-out Wingate test

Group Type EXPERIMENTAL

20 km time trial

Intervention Type BEHAVIORAL

20 km time trial cycling test will be conducted to measure the effect of different drinks on time

Wingate test

Intervention Type BEHAVIORAL

30 second all-out effort on a bike will be conducted to measure the effect of different drinks on peak power output

Ketone/Caffeine

Intervention Type DIETARY_SUPPLEMENT

Dietary supplement containing ketone salts and caffeine

Interventions

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20 km time trial

20 km time trial cycling test will be conducted to measure the effect of different drinks on time

Intervention Type BEHAVIORAL

Wingate test

30 second all-out effort on a bike will be conducted to measure the effect of different drinks on peak power output

Intervention Type BEHAVIORAL

Ketone/Caffeine

Dietary supplement containing ketone salts and caffeine

Intervention Type DIETARY_SUPPLEMENT

Ketone

Dietary supplement containing only ketone salts

Intervention Type DIETARY_SUPPLEMENT

Water Placebo

Dietary supplement containing only water

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female recreationally active individuals
* aged 15-35 years
* non regular caffeine users.

Exclusion Criteria

* Smoker
* Taking part in other research
* Sedentary
* For women, if they are pregnant or become pregnant during the study
* Injury limiting exercise ability.
* Have symptoms or take medication for respiratory disease
* Have symptoms or take medication for cardiovascular disease
* Have symptoms or take mediation for neuromuscular disease
* Use heart rate or blood pressure medications
* Use any medications with side effects of dizziness, lack of motor control, or slowed reaction time
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Western University, Canada

OTHER

Sponsor Role lead

Responsible Party

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Peter Lemon

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Lemon, PhD

Role: PRINCIPAL_INVESTIGATOR

Western University

Locations

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Exercise Nutrition Laboratory (Western University)

London, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Peter Lemon, PhD

Role: CONTACT

519 6612111 ext. 88139

Manuel D Quinones, MSc

Role: CONTACT

5196612111 ext. 88164

Facility Contacts

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Peter Lemon, PhD

Role: primary

519 6612111 ext. 88139

Other Identifiers

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113474

Identifier Type: -

Identifier Source: org_study_id

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