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Exogenous Ketone Supplementation and Exercise Performance

Primary Purpose

Ketonemia, Ketosis

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
20 km time trial
Wingate test
Ketone/Caffeine
Ketone
Water Placebo
Sponsored by
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ketonemia

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy male and female recreationally active individuals
  • aged 15-35 years
  • non regular caffeine users.

Exclusion Criteria:

  • Smoker
  • Taking part in other research
  • Sedentary
  • For women, if they are pregnant or become pregnant during the study
  • Injury limiting exercise ability.
  • Have symptoms or take medication for respiratory disease
  • Have symptoms or take medication for cardiovascular disease
  • Have symptoms or take mediation for neuromuscular disease
  • Use heart rate or blood pressure medications
  • Use any medications with side effects of dizziness, lack of motor control, or slowed reaction time

Sites / Locations

  • Exercise Nutrition Laboratory (Western University)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Water Placebo

Experimental 1

Experimental 2

Arm Description

Placebo flavored drink similar to treatments but with no energy will be ingested before completing a 20km Time trial and a 30 second all-out Wingate test

Ketone salts supplement mixed in water will be ingested before completing a 20km Time trial and a 30 second all-out Wingate test

Ketone salts/caffeine supplement mixed in water will be ingested before completing a 20km Time trial and a 30 second all-out Wingate test

Outcomes

Primary Outcome Measures

20 km time trial
participants will ride for 20 km on a stationary bike and time to complete distance will be measured.
Wingate test
participants will perform a ver short all-out effort on a stationary bike. peak power output and fatigue index will be measured.

Secondary Outcome Measures

Blood Ketone
blood ketones will be measured using ketone meter
Blood Lactate
blood lactate will be measured using lactate meter
Rates of perceived exertion (RPE)
RPE will be measured using Borg's scale (1= low - 10= high).

Full Information

First Posted
February 13, 2019
Last Updated
September 30, 2019
Sponsor
Western University, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT03895892
Brief Title
Exogenous Ketone Supplementation and Exercise Performance
Official Title
The Effect of Exogenous Ketone Supplementation on 20 km Time Trial and Wingate Performance in Recreationally Active Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
20 healthy recreationally active men and woman aged 18-35 will participate in the study. There will be three treatments involved: Caffeinated ketone supplements, non-caffeinated ketone supplement and water-placebo. Participants will complete the protocol three times and the treatment order will be systematically rotated to avoid any order effect. The three main trials will be separated by at least 1 week. After providing the corresponding treatment, participants will be given 30 minutes and after, they will perform a standardized 10-minute warm-up, followed by the 20 km time trial and a 30-second all-out Wingate test.
Detailed Description
Some researchers support that a state of ketosis, reached through the use of ketogenic diet, has the potential to improve athletic. To attain such state, individuals must restrict carbohydrate intake to a maximum of 50g/ day or 10% while keeping protein intake moderate. One of the biggest challenges to achieve and maintain ketosis is complying with the diet due to its restrictive nature. Consequently, manufacturers have developed supplements that can induce a state of ketosis acutely (~1 hour). Unfortunately, there is very little evidence supporting the use of these supplements to enhance athletic performance. Hyperketonemia (blood ketone concentration > 0.2 Mm) seems to elevate the rate of utilization of ketone bodies. These changes in substrate utilization may allow athletes to preserve, something that would be advantageous for exercise performance. Ketone salts have been shown to elevate the concentration of ketones in blood and as such they may allow the body benefit from the apparent sparing of carbohydrates. Manufacturers now provide ketones salts combined with other ingredients such as caffeine. However it is unknown whether or not the addition of these ingredients has any positive or negative effect on athletic performance. Caffeine alone has been shown to improve athletic performance in several studies. Therefore, the purpose of this study is to compare the effectiveness of a caffeine free ketone salt supplement vs a caffeinated ketone salt supplement and their effects on a 20km time trial and a 30 second all-out Wingate test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ketonemia, Ketosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This will be a double blind repeated measures cross over study. There will be three treatments involved: Caffeinated ketone supplements, non-caffeinated ketone supplement and water-placebo. Participants will complete the protocol three times and the treatment order will be systematically rotated to avoid any order effect. Design of the study is composed of two performance tests 30 minutes following supplementation. All participants will arrive in a fed state to the laboratory. the corresponding treatment will be provided and 30 minutes later, they will perform a 20 km time trial. 10 minutes after the time trial, participants will perform a 30 second all-out Wingate test.
Masking
ParticipantInvestigator
Masking Description
Participants and investigators will be blinded as an individual not involved in the project will assemble and distribute the treatment (drinks) according to a coding system that is kept confidential until the study is completed. Participants will complete the protocol three times and the treatment order will be systematically rotated to avoid any order effect. taste and texture of treatments will be matched and will be distribute in opaque bottles to keep participant blinded
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Water Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo flavored drink similar to treatments but with no energy will be ingested before completing a 20km Time trial and a 30 second all-out Wingate test
Arm Title
Experimental 1
Arm Type
Experimental
Arm Description
Ketone salts supplement mixed in water will be ingested before completing a 20km Time trial and a 30 second all-out Wingate test
Arm Title
Experimental 2
Arm Type
Experimental
Arm Description
Ketone salts/caffeine supplement mixed in water will be ingested before completing a 20km Time trial and a 30 second all-out Wingate test
Intervention Type
Behavioral
Intervention Name(s)
20 km time trial
Intervention Description
20 km time trial cycling test will be conducted to measure the effect of different drinks on time
Intervention Type
Behavioral
Intervention Name(s)
Wingate test
Intervention Description
30 second all-out effort on a bike will be conducted to measure the effect of different drinks on peak power output
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketone/Caffeine
Intervention Description
Dietary supplement containing ketone salts and caffeine
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketone
Intervention Description
Dietary supplement containing only ketone salts
Intervention Type
Dietary Supplement
Intervention Name(s)
Water Placebo
Intervention Description
Dietary supplement containing only water
Primary Outcome Measure Information:
Title
20 km time trial
Description
participants will ride for 20 km on a stationary bike and time to complete distance will be measured.
Time Frame
40 minutes
Title
Wingate test
Description
participants will perform a ver short all-out effort on a stationary bike. peak power output and fatigue index will be measured.
Time Frame
30 seconds
Secondary Outcome Measure Information:
Title
Blood Ketone
Description
blood ketones will be measured using ketone meter
Time Frame
1 hour
Title
Blood Lactate
Description
blood lactate will be measured using lactate meter
Time Frame
1 hour
Title
Rates of perceived exertion (RPE)
Description
RPE will be measured using Borg's scale (1= low - 10= high).
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy male and female recreationally active individuals aged 15-35 years non regular caffeine users. Exclusion Criteria: Smoker Taking part in other research Sedentary For women, if they are pregnant or become pregnant during the study Injury limiting exercise ability. Have symptoms or take medication for respiratory disease Have symptoms or take medication for cardiovascular disease Have symptoms or take mediation for neuromuscular disease Use heart rate or blood pressure medications Use any medications with side effects of dizziness, lack of motor control, or slowed reaction time
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Lemon, PhD
Phone
519 6612111
Ext
88139
Email
plemon@uwo.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel D Quinones, MSc
Phone
5196612111
Ext
88164
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter 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
N6A 3K7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Lemon, PhD
Phone
519 6612111
Ext
88139
Email
plemon@uwo.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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Exogenous Ketone Supplementation and Exercise Performance

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