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Ketone Supplementation and Exercise Performance

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ClinicalTrials.gov Identifier: NCT03954665
Recruitment Status : Not yet recruiting
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Western University, Canada

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).

Condition or disease Intervention/treatment Phase
Ketosis Exercise Performance Ketoses, Metabolic Behavioral: 10 km time trial Behavioral: 30s Wingate Dietary Supplement: Ketone Behavioral: Baseline 10 km time trial Behavioral: Baseline 30s Wingate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Can Ketone Supplementation Enhance Exercise Performance?
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Baseline Testing
Baseline testing for a 10km cycle time trial and a 30s Wingate cycle test.
Behavioral: Baseline 10 km time trial
A baseline 10 km Cycling time trial test will be conducted

Behavioral: Baseline 30s Wingate
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.
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

Behavioral: 30s Wingate
30s all-out test to measure peak power output

Dietary Supplement: Ketone
Supplement containing exogenous ketone salts




Primary Outcome Measures :
  1. 10 km Time trial [ Time Frame: 15-20 Minutes ]
    10km time trial where participants will be measured on time to completion

  2. 30s Wingate [ Time Frame: 30 seconds ]
    30s Wingate all out test where participants will be measured on their peak power output


Secondary Outcome Measures :
  1. Blood Ketones [ Time Frame: 1-2 hours ]
    Blood Ketones will be measured using a ketone meter

  2. Blood Glucose [ Time Frame: 1-2 hours ]
    Blood Glucose will be measured using a Blood glucose meter

  3. Blood Lactate [ Time Frame: 1-2 hours ]
    Blood Lactate will be measured using a lactate meter



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03954665


Contacts
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Contact: Sydney EL Isbell, BSc 5196612111 sisbell@uwo.ca
Contact: Manuel D Quinones, MSc 5196612111

Locations
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Canada, Ontario
Exercise Nutrition Laboratory, Western University Not yet recruiting
London, Ontario, Canada, N6A3K7
Contact: Peter WR Lemon, PhD    5196612111 ext 88139    plemon@uwo.ca   
Sponsors and Collaborators
Western University, Canada
Investigators
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Principal Investigator: Peter WR Lemon, PhD Western University

Publications of Results:
Other Publications:
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Responsible Party: Western University, Canada
ClinicalTrials.gov Identifier: NCT03954665     History of Changes
Other Study ID Numbers: 113761
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Western University, Canada:
Ketones
Supplementation
Exercise Performance

Additional relevant MeSH terms:
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Ketosis
Acidosis
Acid-Base Imbalance
Metabolic Diseases