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

Exercise Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05665855
• Other study ID #: 15110
• Status: Completed
• Phase: N/A
• Start date: December 27, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 30, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Exercise
• Ketosis

Intervention

Dietary Supplement:
• Ketone monoester
A commercial liquid ketone monoester supplement.

Other:
• Placebo
A liquid placebo that is 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	Exercise efficiency	Power output expressed relative to pulmonary oxygen uptake to determine cycling economy in watt per litre of oxygen per minute	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	Heart rate	Mean heart rate	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	Rating of perceived exertion	Rating of perceived exertion measured using a 6-20 scale	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
Secondary	Ketone body content in venous blood	Mixed venous blood content of the ketone body beta-hydroxybutyrate	Measurement made immediately prior to exercise