The Effects of Acute Ketone Monoester Supplementation on 20-Minute Time-Trial Performance in Trained Cyclists
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2022
CompletedFirst Posted
Study publicly available on registry
February 7, 2022
CompletedStudy Start
First participant enrolled
February 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedNovember 7, 2022
November 1, 2022
7 months
January 27, 2022
November 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Power output
Mean power output produced while cycling
20-minute measurement during exercise
Secondary Outcomes (4)
Heart rate
20-minute measurement during exercise
Perceived exertion
Single measurement immediately after exercise
Blood ketone
Single measurement immediately prior to exercise
Blood glucose
20-minute measurement during exercise
Study Arms (2)
Ketone
ACTIVE COMPARATORAn acute bout of exercise performed after the ingestion of a commercial ketone monoester supplement.
Control
PLACEBO COMPARATORAn acute bout of exercise performed after the ingestion of a taste-matched placebo supplement.
Interventions
A commercial liquid supplement ingested in a dose intended to provide \~0.35 g of ketone monoester per kg body mass of the participant
A liquid placebo that is volume- and taste-matched to the ketone monoester supplement
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
McMaster University
Hamilton, Ontario, L8S4K1, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Gibala, PhD
McMaster University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 27, 2022
First Posted
February 7, 2022
Study Start
February 15, 2022
Primary Completion
September 1, 2022
Study Completion
October 1, 2022
Last Updated
November 7, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share