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Ketone Supplementation and Exercise Performance

Primary Purpose

Ketosis, Exercise Performance, Ketoses, Metabolic

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
10 km time trial
30s Wingate
Ketone
Baseline 10 km time trial
Baseline 30s Wingate
Sponsored by
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ketosis focused on measuring Ketones, Supplementation, Exercise Performance

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Exercise Nutrition Laboratory, Western University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Baseline Testing

Dietary Supplement: Exogenous Ketone Salt

Arm Description

Baseline testing for a 10km cycle time trial and a 30s Wingate cycle test.

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.

Outcomes

Primary Outcome Measures

10 km Time trial
10km time trial where participants will be measured on time to completion
30s Wingate
30s Wingate all out test where participants will be measured on their peak power output

Secondary Outcome Measures

Blood Ketones
Blood Ketones will be measured using a ketone meter
Blood Glucose
Blood Glucose will be measured using a Blood glucose meter
Blood Lactate
Blood Lactate will be measured using a lactate meter

Full Information

First Posted
May 6, 2019
Last Updated
July 22, 2019
Sponsor
Western University, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT03954665
Brief Title
Ketone Supplementation and Exercise Performance
Official Title
Can Ketone Supplementation Enhance Exercise Performance?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 2019 (Anticipated)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western University, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ketosis, Exercise Performance, Ketoses, Metabolic
Keywords
Ketones, Supplementation, Exercise Performance

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Baseline Testing
Arm Type
Active Comparator
Arm Description
Baseline testing for a 10km cycle time trial and a 30s Wingate cycle test.
Arm Title
Dietary Supplement: Exogenous Ketone Salt
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
10 km time trial
Intervention Description
10 km Cycling time trial test will be conducted to examine the effects of the Exogenous Ketone Salts on time
Intervention Type
Behavioral
Intervention Name(s)
30s Wingate
Intervention Description
30s all-out test to measure peak power output
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketone
Intervention Description
Supplement containing exogenous ketone salts
Intervention Type
Behavioral
Intervention Name(s)
Baseline 10 km time trial
Intervention Description
A baseline 10 km Cycling time trial test will be conducted
Intervention Type
Behavioral
Intervention Name(s)
Baseline 30s Wingate
Intervention Description
A baseline 30s all-out test to measure peak power output
Primary Outcome Measure Information:
Title
10 km Time trial
Description
10km time trial where participants will be measured on time to completion
Time Frame
15-20 Minutes
Title
30s Wingate
Description
30s Wingate all out test where participants will be measured on their peak power output
Time Frame
30 seconds
Secondary Outcome Measure Information:
Title
Blood Ketones
Description
Blood Ketones will be measured using a ketone meter
Time Frame
1-2 hours
Title
Blood Glucose
Description
Blood Glucose will be measured using a Blood glucose meter
Time Frame
1-2 hours
Title
Blood Lactate
Description
Blood Lactate will be measured using a lactate meter
Time Frame
1-2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sydney EL Isbell, BSc
Phone
5196612111
Email
sisbell@uwo.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel D Quinones, MSc
Phone
5196612111
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter WR Lemon, PhD
Organizational Affiliation
Western University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Exercise Nutrition Laboratory, Western University
City
London
State/Province
Ontario
ZIP/Postal Code
N6A3K7
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter WR Lemon, PhD
Phone
5196612111
Ext
88139
Email
plemon@uwo.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29451991
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.
Results Reference
background
PubMed Identifier
28750585
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.
Results Reference
background
PubMed Identifier
25275931
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.
Results Reference
result

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Ketone Supplementation and Exercise Performance

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