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Completed

NCT Number: NCT05226962

The Effects of Acute Ketone Monoester Supplementation on 20-Minute Time-Trial Performance in Trained Cyclists

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 time trial performance. Participants will perform two trials in a randomized order. Each trial will involve a 20-minute bout of cycling on a stationary ergometer. Participants will ingest either 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 responses.

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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 time trial performance. Trained participants with competitive cycling experience will be recruited. Exercise will involve a 20-minute bout of cycling on a stationary ergometer with the goal of producing the highest power output possible. Participants will ingest either 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 responses.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Habitually ingesting >50 g of dietary carbohydrate daily i.e. not following a ketogenic diet.
  • Regularly performing cycling exercise at least 3 days per week and for a total of ≥5 hours per week.
  • Having an estimated peak oxygen uptake of ≥55 ml/kg/min for males and ≥48 ml/kg/min for females based on the online fitness calculator available at: www.worldfitnesslevel.org.
  • Having competitive cycling experience.

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 supplement ingested in a dose intended to provide ~0.35 g of ketone monoester per kg body mass of the participant

Placebo

Other

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

Primary outcomes

  1. Power output

    Time frame: 20-minute measurement during exercise

    Mean power output produced while cycling

Secondary outcomes

  1. Heart rate

    Time frame: 20-minute measurement during exercise

    Mean heart rate while cycling

  2. Perceived exertion

    Time frame: Single measurement immediately after exercise

    Rating of perceived exertion while cycling

  3. Blood ketone

    Time frame: Single measurement immediately prior to exercise

    Blood ketone before exercise

  4. Blood glucose

    Time frame: 20-minute measurement during exercise

    Mean blood glucose while cycling

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 7, 2022
Registry last updated
Nov 7, 2022

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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