- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02825823
The Effects of Exogenous Ketones on Exercise Performance in Young Healthy Adults
October 12, 2017 updated by: Jonathan Little, University of British Columbia
The ketone body beta-hydroxybutyrate is produced during prolonged fasting or exercise and can be used as an alternative fuel source.
Exogenous beta-hydroxybutyrate, in the form of a ketone salt, is proposed to have ergogenic potential for high-intensity exercise performance but this has not been adequately studied.
The purpose of this study is to determine whether supplementing with an acute dose of ketone salts can alter fuel use during exercise and improve exercise performance.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
-
Kelowna, British Columbia, Canada, V1V 1V7
- University of British Columbia, Okanagan.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Males aged 18-40
- Ability to understand and communicate in English to answer questionnaires and interact with the research assistant
- Physically active (defined by engaging in moderate-to-vigorous exercise at least 3 times per week, determined via validated questionnaire)
Exclusion Criteria:
- Diagnosed with diabetes or any other medical conditions that could affect metabolism.
- Diagnosed with heart disease or taking anti-hypertensive medications.
- Competitive endurance athlete (self-identified as engaged in specific endurance training in triathlon, cycling, or distance running and competing in races or competition)
- Recent (last 3 months) or current consumption of a low-carbohydrate ketogenic diet
- Current consumption of ketone supplements
- Any other contraindication to vigorous exercise (identified via physical activity readiness questionnaire [PAR-Q])
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ketone Salts
Acute dose of beta-hydroxybutyrate potassium/sodium salt (0.2g beta-hydroxybutyrate/kg, 0.01g Potassium/kg, 0.01g Sodium/kg with 1 g Steviol Glycoside and 30 ml of lemon juice per dose)
|
|
|
Placebo Comparator: Placebo
Acute dose of taste-matched placebo (0.01g Potassium/kg, 0.01g Sodium/kg with 1 g Steviol Glycoside and 30 ml of lemon juice per dose)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Respiratory Exchange Ratio (RER) during cycling exercise
Time Frame: 0-18 minutes
|
The RER during 18 minutes of steady-state exercise
|
0-18 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
10 km Cycling Time Trial Performance
Time Frame: Following 18 minutes of steady-state exercise
|
10 km time trial performed on a stationary bicycle following 18 minutes of steady-state exercise
|
Following 18 minutes of steady-state exercise
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2016
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
July 4, 2016
First Submitted That Met QC Criteria
July 4, 2016
First Posted (Estimate)
July 7, 2016
Study Record Updates
Last Update Posted (Actual)
October 13, 2017
Last Update Submitted That Met QC Criteria
October 12, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- H1601260
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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