Clinical trial NCT03954665: Ketone Supplementation and Exercise Performance
Official title: Can Ketone Supplementation Enhance Exercise Performance?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ketosis
Exercise Performance
Ketoses, Metabolic
Keywords: Ketones
Supplementation
Exercise Performance
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2019-05-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 10 km Time trial
timeFrame: 15-20 Minutes
measure: 30s Wingate
timeFrame: 30 seconds
Secondary outcomes:
measure: Blood Ketones
timeFrame: 1-2 hours
measure: Blood Glucose
timeFrame: 1-2 hours
measure: Blood Lactate
timeFrame: 1-2 hours
Other outcomes:
Locations:
city: London
country: Canada
facility: Exercise Nutrition Laboratory, Western University
state: Ontario
Study officials:
affiliation: Western University
name: Peter WR Lemon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.