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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03954665
Other study ID # 113761
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2019
Est. completion date March 2020

Study information

Verified date April 2019
Source Western University, Canada
Contact Sydney EL Isbell, BSc
Phone 5196612111
Email sisbell@uwo.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date March 2020
Est. primary completion date January 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
10 km time trial
10 km Cycling time trial test will be conducted to examine the effects of the Exogenous Ketone Salts on time
30s Wingate
30s all-out test to measure peak power output
Dietary Supplement:
Ketone
Supplement containing exogenous ketone salts
Behavioral:
Baseline 10 km time trial
A baseline 10 km Cycling time trial test will be conducted
Baseline 30s Wingate
A baseline 30s all-out test to measure peak power output

Locations

Country Name City State
Canada Exercise Nutrition Laboratory, Western University London Ontario

Sponsors (1)

Lead Sponsor Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 10 km Time trial 10km time trial where participants will be measured on time to completion 15-20 Minutes
Primary 30s Wingate 30s Wingate all out test where participants will be measured on their peak power output 30 seconds
Secondary Blood Ketones Blood Ketones will be measured using a ketone meter 1-2 hours
Secondary Blood Glucose Blood Glucose will be measured using a Blood glucose meter 1-2 hours
Secondary Blood Lactate Blood Lactate will be measured using a lactate meter 1-2 hours
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