Clinical trial NCT05226962: The Effects of Acute Ketone Monoester Supplementation on 20-Minute Time-Trial Performance in Trained Cyclists
Official title: The Effects of Acute Ketone Monoester Supplementation on 20-Minute Time-Trial Performance in Trained Cyclists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise
Ketosis
Keywords: Performance
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Power output
timeFrame: 20-minute measurement during exercise
Secondary outcomes:
measure: Heart rate
timeFrame: 20-minute measurement during exercise
measure: Perceived exertion
timeFrame: Single measurement immediately after exercise
measure: Blood ketone
timeFrame: Single measurement immediately prior to exercise
measure: Blood glucose
timeFrame: 20-minute measurement during exercise
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Martin Gibala, PhD
role: PRINCIPAL_INVESTIGATOR
References: