Ketone Supplementation and Exercise Performance

Ketosis Clinical Trial

Official title:

Can Ketone Supplementation Enhance Exercise Performance?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03954665
• Other study ID #: 113761
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Exercise Performance
• Ketoses, Metabolic
• Ketosis

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