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Completed

NCT Number: NCT05665855

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University

Hamilton, Ontario, L8S4K1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ketone monoester

Dietary Supplement

A commercial liquid ketone monoester supplement.

Placebo

Other

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

Primary outcomes

  1. Exercise efficiency

    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

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

Secondary outcomes

  1. 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

    Mean heart rate

  2. Rating of perceived exertion

    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

    Rating of perceived exertion measured using a 6-20 scale

  3. Ketone body content in venous blood

    Time frame: Measurement made immediately prior to exercise

    Mixed venous blood content of the ketone body beta-hydroxybutyrate

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 27, 2022
Registry last updated
Jul 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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