Back to resultsThe Effects of Acute Ketone Monoester Supplementation on 20-Minute Time-Trial Performance in Trained Cyclists
Primary Purpose
Exercise, Ketosis
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ketone monoester
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Exercise focused on measuring Performance
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.
Sites / Locations
- McMaster University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ketone
Control
Arm Description
An acute bout of exercise performed after the ingestion of a commercial ketone monoester supplement.
An acute bout of exercise performed after the ingestion of a taste-matched placebo supplement.
Outcomes
Primary Outcome Measures
Power output
Mean power output produced while cycling
Secondary Outcome Measures
Heart rate
Mean heart rate while cycling
Perceived exertion
Rating of perceived exertion while cycling
Blood ketone
Blood ketone before exercise
Blood glucose
Mean blood glucose while cycling
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05226962
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise, Ketosis
Keywords
Performance
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketone
Arm Type
Active Comparator
Arm Description
An acute bout of exercise performed after the ingestion of a commercial ketone monoester supplement.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
An acute bout of exercise performed after the ingestion of a taste-matched placebo supplement.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketone monoester
Intervention Description
A commercial liquid supplement ingested in a dose intended to provide ~0.35 g of ketone monoester per kg body mass of the participant
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
A liquid placebo that is volume- and taste-matched to the ketone monoester supplement
Primary Outcome Measure Information:
Title
Power output
Description
Mean power output produced while cycling
Time Frame
20-minute measurement during exercise
Secondary Outcome Measure Information:
Title
Heart rate
Description
Mean heart rate while cycling
Time Frame
20-minute measurement during exercise
Title
Perceived exertion
Description
Rating of perceived exertion while cycling
Time Frame
Single measurement immediately after exercise
Title
Blood ketone
Description
Blood ketone before exercise
Time Frame
Single measurement immediately prior to exercise
Title
Blood glucose
Description
Mean blood glucose while cycling
Time Frame
20-minute measurement during exercise
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Gibala, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S4K1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effects of Acute Ketone Monoester Supplementation on 20-Minute Time-Trial Performance in Trained Cyclists
We'll reach out to this number within 24 hrs