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The Effects of Acute Ketone Monoester Supplementation on Exercise Efficiency and the Influence of Dose and Intensity

Primary Purpose

Exercise, Ketosis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ketone monoester
Placebo
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Exercise focused on measuring Efficiency

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Be habitually consuming ≥50 g/d of carbohydrate (i.e., not following a ketogenic diet). Be engaged in endurance-type exercise >3h/wk. Have an estimated VO2peak of ≥90% for age and sex as estimated by an online calculator found at www.worldfitnesslevel.org. Exclusion Criteria: Experiencing a condition that might preclude safe participation in physical activity and exercise, as determined by answering "Yes" to any question on Page 1 of the Canadian Society for Exercise Physiology Get Active Questionnaire.

Sites / Locations

  • McMaster University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Ketone higher dose

Ketone lower dose

Control

Arm Description

An acute bout of exercise performed after the ingestion of a commercial supplement intended to provide ~0.6 g of ketone monoester per kg body mass of the participant.

An acute bout of exercise performed after the ingestion of a commercial supplement intended to provide ~0.3 g of ketone monoester per kg body mass of the participant.

An acute bout of exercise performed after the ingestion of a taste-matched placebo supplement.

Outcomes

Primary Outcome Measures

Exercise efficiency
Power output expressed relative to pulmonary oxygen uptake to determine cycling economy in watt per litre of oxygen per minute

Secondary Outcome Measures

Heart rate
Mean heart rate
Rating of perceived exertion
Rating of perceived exertion measured using a 6-20 scale
Ketone body content in venous blood
Mixed venous blood content of the ketone body beta-hydroxybutyrate

Full Information

First Posted
November 17, 2022
Last Updated
July 7, 2023
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT05665855
Brief Title
The Effects of Acute Ketone Monoester Supplementation on Exercise Efficiency and the Influence of Dose and Intensity
Official Title
The Effects of Acute Ketone Monoester Supplementation on Exercise Efficiency and the Influence of Dose and Intensity
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 27, 2022 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Diet can alter blood ketone levels and this in turn may affect exercise capacity. This study will determine if the acute ingestion of a ketone supplement alters cycling exercise efficiency. Participants will perform three trials in a randomized order. Each trial will involve an incremental exercise protocol on a stationary cycle ergometer to volitional fatigue. Participants will ingest either a high or low dose of a ketone supplement or a taste-matched placebo drink prior to exercise. Blood samples will be obtained to assess selected metabolic responses. This study will provide information regarding the effect of ketone supplementation on exercise efficiency.
Detailed Description
This study will determine if the acute ingestion of a ketone supplement alters cycling exercise efficiency. Trained participants with cycling experience will be recruited. Participants will perform three trials in a randomized order. Each trial will involve a 3-minute warm-up followed by an incremental ramp test. The ramp will initially consist of three, 5-minute stages performed at relative workloads corresponding to 75%, 100%, and 125% of individual ventilatory threshold intensity. This will be followed by a further incremental ramp test to volitional fatigue. Participants will ingest either a high or low dose of a ketone supplement or a taste-matched placebo drink prior to exercise using a randomized, double-blind crossover design. Diet prior to exercise will be standardized between trials for a given participant. Blood samples will be obtained to assess selected metabolic responses. This study will provide information regarding the effect of ketone supplementation on exercise efficiency.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise, Ketosis
Keywords
Efficiency

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketone higher dose
Arm Type
Experimental
Arm Description
An acute bout of exercise performed after the ingestion of a commercial supplement intended to provide ~0.6 g of ketone monoester per kg body mass of the participant.
Arm Title
Ketone lower dose
Arm Type
Experimental
Arm Description
An acute bout of exercise performed after the ingestion of a commercial supplement intended to provide ~0.3 g of ketone monoester per kg body mass of the participant.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
An acute bout of exercise performed after the ingestion of a taste-matched placebo supplement.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketone monoester
Intervention Description
A commercial liquid ketone monoester supplement.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
A liquid placebo that is taste-matched to the ketone monoester supplement.
Primary Outcome Measure Information:
Title
Exercise efficiency
Description
Power output expressed relative to pulmonary oxygen uptake to determine cycling economy in watt per litre of oxygen per minute
Time Frame
Continuous measurement made over each of three, 5-minute consecutive stages of an incremental cycle exercise test at relative workloads corresponding to 75%, 100%, and 125% of individual ventilatory threshold intensity
Secondary Outcome Measure Information:
Title
Heart rate
Description
Mean heart rate
Time Frame
Continuous measurement made over each of three, 5-minute consecutive stages of an incremental cycle exercise test at relative workloads corresponding to 75%, 100%, and 125% of individual ventilatory threshold intensity
Title
Rating of perceived exertion
Description
Rating of perceived exertion measured using a 6-20 scale
Time Frame
Measurement made at the end of each of three, 5-minute consecutive stages of an incremental cycle exercise test at relative workloads corresponding to 75%, 100%, and 125% of individual ventilatory threshold intensity
Title
Ketone body content in venous blood
Description
Mixed venous blood content of the ketone body beta-hydroxybutyrate
Time Frame
Measurement made immediately prior to exercise

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Be habitually consuming ≥50 g/d of carbohydrate (i.e., not following a ketogenic diet). Be engaged in endurance-type exercise >3h/wk. Have an estimated VO2peak of ≥90% for age and sex as estimated by an online calculator found at www.worldfitnesslevel.org. Exclusion Criteria: Experiencing a condition that might preclude safe participation in physical activity and exercise, as determined by answering "Yes" to any question on Page 1 of the Canadian Society for Exercise Physiology Get Active Questionnaire.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin J Gibala, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S4K1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effects of Acute Ketone Monoester Supplementation on Exercise Efficiency and the Influence of Dose and Intensity

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