- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03954665
Ketone Supplementation and Exercise Performance
July 22, 2019 updated by: Western University, Canada
Can Ketone Supplementation Enhance Exercise Performance?
The purpose of this study is to observe the effects of exogenous ketone supplements during shorter bouts of exercise testing on twenty collegiate endurance trained athletes (18-25 years of age).
Study Overview
Status
Unknown
Conditions
Detailed Description
Some believe very high fat diets (>70% energy) can enhance exercise performance by providing additional fuel (ketones) for energy metabolism, at least for very prolonged exercise (>3-4h).
Regardless, this diet is difficult to maintain so it has been suggested that ingesting ketone salts along with a normal carbohydrate (CHO) diet might be more practical.
The purpose of this study is to observe the effects of ketone salt ingestion on shorter term (up to ~15 min) exercise performance.
Endurance trained (≥2 year training experience; ≥7 h/week) collegiate athletes (n=20) of similar body mass (♀; 55-60kg; ♂; 75-80kg) and age 18-25y) consuming 5-6g CHO•kg-1•d-1) will be tested before and after 1 and 7d of ketone salt (Prüvit, Carrollton TX, US) supplementation (0.6-0.8g•kg-1•d-1).
Participants will perform two exercise performance tests (a 10km cycle time trial and a 30s Wingate cycle test on separate days) before and after supplementation.
Blood samples (glucose, lactic acid, and ketone concentration) will be taken at: baseline and following each performance test.
It is hypothesized that ketone salt supplementation will increase blood ketone concentration but will not enhance these exercise performance tests.
Study Type
Interventional
Enrollment (Anticipated)
20
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 Contact
- Name: Sydney EL Isbell, BSc
- Phone Number: 5196612111
- Email: sisbell@uwo.ca
Study Contact Backup
- Name: Manuel D Quinones, MSc
- Phone Number: 5196612111
Study Locations
-
-
Ontario
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London, Ontario, Canada, N6A3K7
- Exercise Nutrition Laboratory, Western University
-
-
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 25 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy male or female Collegiate Endurance Trained Athletes
- ≥2 year training experience; ≥7 h/week
- Ages 18-25
Exclusion Criteria:
- Smoker
- Injury that will affect exercise performance
- Sedentary Behaviour
- Currently following a High Fat diet/Ketogenic diet
- Taking Beta Blockers or Hypertension Medication
- Has Respiratory, Cardiovascular and/or Neuromuscular disease that is not cleared for exercise by a physician.
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: OTHER
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Baseline Testing
Baseline testing for a 10km cycle time trial and a 30s Wingate cycle test.
|
A baseline 10 km Cycling time trial test will be conducted
A baseline 30s all-out test to measure peak power output
|
EXPERIMENTAL: Dietary Supplement: Exogenous Ketone Salt
Ketone salt supplementation (0.6-0.8g•kg-1•d-1) 7-days.
Participants will perform two exercise performance tests (a 10km cycle time trial and a 30s Wingate cycle test on separate days) after supplementation.
|
10 km Cycling time trial test will be conducted to examine the effects of the Exogenous Ketone Salts on time
30s all-out test to measure peak power output
Supplement containing exogenous ketone salts
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
10 km Time trial
Time Frame: 15-20 Minutes
|
10km time trial where participants will be measured on time to completion
|
15-20 Minutes
|
30s Wingate
Time Frame: 30 seconds
|
30s Wingate all out test where participants will be measured on their peak power output
|
30 seconds
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood Ketones
Time Frame: 1-2 hours
|
Blood Ketones will be measured using a ketone meter
|
1-2 hours
|
Blood Glucose
Time Frame: 1-2 hours
|
Blood Glucose will be measured using a Blood glucose meter
|
1-2 hours
|
Blood Lactate
Time Frame: 1-2 hours
|
Blood Lactate will be measured using a lactate meter
|
1-2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Waldman HS, Basham SA, Price FG, Smith JW, Chander H, Knight AC, Krings BM, McAllister MJ. Exogenous ketone salts do not improve cognitive responses after a high-intensity exercise protocol in healthy college-aged males. Appl Physiol Nutr Metab. 2018 Jul;43(7):711-717. doi: 10.1139/apnm-2017-0724. Epub 2018 Feb 16.
- O'Malley T, Myette-Cote E, Durrer C, Little JP. Nutritional ketone salts increase fat oxidation but impair high-intensity exercise performance in healthy adult males. Appl Physiol Nutr Metab. 2017 Oct;42(10):1031-1035. doi: 10.1139/apnm-2016-0641. Epub 2017 Jul 27.
- Volek JS, Noakes T, Phinney SD. Rethinking fat as a fuel for endurance exercise. Eur J Sport Sci. 2015;15(1):13-20. doi: 10.1080/17461391.2014.959564. Epub 2014 Oct 2.
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 (ANTICIPATED)
September 1, 2019
Primary Completion (ANTICIPATED)
January 1, 2020
Study Completion (ANTICIPATED)
March 1, 2020
Study Registration Dates
First Submitted
May 6, 2019
First Submitted That Met QC Criteria
May 16, 2019
First Posted (ACTUAL)
May 17, 2019
Study Record Updates
Last Update Posted (ACTUAL)
July 23, 2019
Last Update Submitted That Met QC Criteria
July 22, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 113761
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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