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

NCT ID: NCT05665855

Last Updated: 2023-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-27
• Study Completion Date: 2023-06-30

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.

Conditions

Exercise; Ketosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Ketone higher dose

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.

Group Type: EXPERIMENTAL

Ketone monoester

Intervention Type: DIETARY_SUPPLEMENT

A commercial liquid ketone monoester supplement.

Ketone lower dose

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.

Group Type: EXPERIMENTAL

Ketone monoester

Intervention Type: DIETARY_SUPPLEMENT

A commercial liquid ketone monoester supplement.

Control

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

A liquid placebo that is taste-matched to the ketone monoester supplement.

Interventions

Ketone monoester

A commercial liquid ketone monoester supplement.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

A liquid placebo that is taste-matched to the ketone monoester supplement.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Martin Gibala

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin J Gibala, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

McMaster University

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

15110

Identifier Type: -

Identifier Source: org_study_id