Ketone Supplementation, Glycogen Replenishment and Time Trial Performance Following Glycogen Lowering Exercise
Primary Purpose
Ketonemia, Exercise Performance, Ketosis
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
20 km time trial performance
Glycogen lowering exercise
Sponsored by
About this trial
This is an interventional other trial for Ketonemia focused on measuring Ketones, Glycogen replenishment, Exercise Performance
Eligibility Criteria
Inclusion Criteria:
- In order to be eligible to participate in this study you must be a healthy male or female exercise trained individual (at least 1y training experience - at least 3x week), aged 18-40 years.
Exclusion Criteria:
- have not involved been involved in regular exercise (at least 3x week for at least the past year)
- Have symptoms or take medication for respiratory, cardiovascular, metabolic, neuromuscular disease
- Use any medications with side effects of dizziness, lack of motor control, or slowed reaction time
- Are taking part in another research study
- For women, if you are pregnant or become pregnant during the study.
- Have a history of concussion/head injuries.
- Have an excessive alcohol intake (>2 drinks/day)
- Are a smoker
Sites / Locations
- Exercise Nutrition Laboratory (Western University)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Placebo
Ketone_CHO
Arm Description
isocaloric carbohydrate - only containing drink will be ingested post glycogen lowering exercise, followed by a 20 km time trial intervention
Ketone - Carbohydrate supplementation will be ingested post glycogen lowering exercise, followed by a 20 km time trial intervention
Outcomes
Primary Outcome Measures
20 km cycling time trial
participants will ride for 20 km on a stationary bike and time to finish will be measured
Secondary Outcome Measures
Blood insulin
insulin in blood will be measured using ELISA kits
Blood Lactate
blood lactate will be measured using lactate meter
Blood Ketones
Ketones in blood will be measured using ketone meter
Full Information
NCT ID
NCT04004676
First Posted
June 27, 2019
Last Updated
September 30, 2019
Sponsor
Western University, Canada
1. Study Identification
Unique Protocol Identification Number
NCT04004676
Brief Title
Ketone Supplementation, Glycogen Replenishment and Time Trial Performance Following Glycogen Lowering Exercise
Official Title
Effect of Ketone Supplementation on Glycogen Replenishment and Time Trial Performance Following Glycogen Lowering Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
September 1, 2020 (Anticipated)
Study Completion Date
September 1, 2020 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
20 healthy trained males will volunteer to participate in this study. there will be 2 treatments: Carbohydrate- ketone supplementation and carbohydrate alone. The purpose of this study is to evaluate the effect of glucose-ketone supplementation on a 20 km cycling time trial with a 2-hour feeding during a 4-hour recovery period following glycogen depleting exercise.
Detailed Description
Carbohydrates (starches & sugars) are important muscle fuel for exercise at moderate to high intensities. Low glycogen content (stored form of carbohydrates in the body) is associated with fatigue. Thus, greater initial glycogen content has been associated with better performance not only in high intensity intermittent sports, but also in prolonged endurance sports. Dose-response studies have determined that ingestion of 1.2 g·kg-1·h-1 of CHO is the appropriate acute recovery dose to optimize glycogen repletion, with no apparent benefit at higher doses. Protein in combination with CHO has also been proposed to enhance glycogen resynthesis when 1 part protein is provided with ~4 parts CHO. Both strategies, optimal CHO intake and CHO in combination with protein for glycogen resynthesis, have resulted in better exercise performance a few hours after a depleting exercise bout. A recent study provided athletes with ketone esters in a drink after glycogen depleting exercise and found that in the presence of high glucose availability, ketone esters increased glycogen stores by 50% compared to a no ketone, high carbohydrate treatment. However, the authors of this study provided a large quantity of carbohydrates intravenously to maintain blood glucose at 10Mm/L. Consequently, it is unknown whether or not ingesting glucose at the optimal dosage would have the same effect. Furthermore, it is unclear whether or not this difference would translate into improved performance in efforts of more moderate duration. Therefore, the purpose of this study is to assess the effect of glucose-ketone supplementation on a 20 km cycling time trial with a 2-hour feeding during a 4-hour recovery period following glycogen depleting exercise.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ketonemia, Exercise Performance, Ketosis
Keywords
Ketones, Glycogen replenishment, Exercise Performance
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 two treatments involved: cabohydrate-ketone supplements and carbohydrates alone (placebo). Participants will complete the protocol twice and the treatment order will be systematically rotated to avoid any order effect. Design of the study is composed of a glycogen depleting exercise session, followed by 4 hours of recovery/supplementation, and a 20 km cycling time trial. All participants will arrive in a fasted state to the laboratory. a glycogen depleting exercise bout will be done followed by a 4 hour recovery period. during this 4 hours, participants will ingest the corresponding treatment for the first 2 hours. after recovery, they will perform a 20 km cycling time trial.
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
Placebo
Arm Type
Active Comparator
Arm Description
isocaloric carbohydrate - only containing drink will be ingested post glycogen lowering exercise, followed by a 20 km time trial intervention
Arm Title
Ketone_CHO
Arm Type
Experimental
Arm Description
Ketone - Carbohydrate supplementation will be ingested post glycogen lowering exercise, followed by a 20 km time trial intervention
Intervention Type
Behavioral
Intervention Name(s)
20 km time trial performance
Intervention Description
20 km time trial cycling test will be conducted to measure the effect of different drinks on performance time
Intervention Type
Behavioral
Intervention Name(s)
Glycogen lowering exercise
Intervention Description
Glycogen will be lowered using a 10-min warm-up period at a workload of 50% max wattage power output (Wmax). Thereafter, participants will be instructed to cycle 2-min block periods at alternating workloads of 90% and 50% of Wmax, respectively. This will be continued until the participants are no longer able to complete the 2 min at 90% Wmax. That moment will be defined as the time at which the individual is unable to maintain cycling speed at 60 revolutions/min. At that moment the high-intensity block will be reduced to 80% Wmax. Again, athletes will cycle until they are unable to complete a 2-min block at 80% Wmax, after which the high-intensity block will be reduced to 70% Wmax. Finally, participants will be allowed to stop when pedalling speed could not be maintained at 70% Wmax.
Primary Outcome Measure Information:
Title
20 km cycling time trial
Description
participants will ride for 20 km on a stationary bike and time to finish will be measured
Time Frame
40 minutes
Secondary Outcome Measure Information:
Title
Blood insulin
Description
insulin in blood will be measured using ELISA kits
Time Frame
2 hours
Title
Blood Lactate
Description
blood lactate will be measured using lactate meter
Time Frame
45 minutes
Title
Blood Ketones
Description
Ketones in blood will be measured using ketone meter
Time Frame
2 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
In order to be eligible to participate in this study you must be a healthy male or female exercise trained individual (at least 1y training experience - at least 3x week), aged 18-40 years.
Exclusion Criteria:
have not involved been involved in regular exercise (at least 3x week for at least the past year)
Have symptoms or take medication for respiratory, cardiovascular, metabolic, neuromuscular disease
Use any medications with side effects of dizziness, lack of motor control, or slowed reaction time
Are taking part in another research study
For women, if you are pregnant or become pregnant during the study.
Have a history of concussion/head injuries.
Have an excessive alcohol intake (>2 drinks/day)
Are a smoker
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 Quinones, MSc
Phone
519 6612111
Ext
88139
Email
mquinon2@uwo.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Lemon, PhD
Organizational Affiliation
Western Universiy
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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Ketone Supplementation, Glycogen Replenishment and Time Trial Performance Following Glycogen Lowering Exercise
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