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

Exercise Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05226962
• Other study ID #: 13837
• Status: Completed
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: October 1, 2022

Study information

• Verified date: November 2022
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Exercise
• Ketosis

Intervention

Dietary Supplement:
• Ketone monoester
A commercial liquid supplement ingested in a dose intended to provide ~0.35 g of ketone monoester per kg body mass of the participant

Other:
• Placebo
A liquid placebo that is volume- and taste-matched to the ketone monoester supplement

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Power output	Mean power output produced while cycling	20-minute measurement during exercise
Secondary	Heart rate	Mean heart rate while cycling	20-minute measurement during exercise
Secondary	Perceived exertion	Rating of perceived exertion while cycling	Single measurement immediately after exercise
Secondary	Blood ketone	Blood ketone before exercise	Single measurement immediately prior to exercise
Secondary	Blood glucose	Mean blood glucose while cycling	20-minute measurement during exercise