- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04004676
Ketone Supplementation, Glycogen Replenishment and Time Trial Performance Following Glycogen Lowering Exercise
September 30, 2019 updated by: Peter Lemon, Western University, Canada
Effect of Ketone Supplementation on Glycogen Replenishment and Time Trial Performance Following Glycogen Lowering Exercise
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 3K7
- Recruiting
- Exercise Nutrition Laboratory (Western University)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Placebo
isocaloric carbohydrate - only containing drink will be ingested post glycogen lowering exercise, followed by a 20 km time trial intervention
|
20 km time trial cycling test will be conducted to measure the effect of different drinks on performance time
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.
|
EXPERIMENTAL: Ketone_CHO
Ketone - Carbohydrate supplementation will be ingested post glycogen lowering exercise, followed by a 20 km time trial intervention
|
20 km time trial cycling test will be conducted to measure the effect of different drinks on performance time
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
20 km cycling time trial
Time Frame: 40 minutes
|
participants will ride for 20 km on a stationary bike and time to finish will be measured
|
40 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood insulin
Time Frame: 2 hours
|
insulin in blood will be measured using ELISA kits
|
2 hours
|
Blood Lactate
Time Frame: 45 minutes
|
blood lactate will be measured using lactate meter
|
45 minutes
|
Blood Ketones
Time Frame: 2 hours
|
Ketones in blood will be measured using ketone meter
|
2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter Lemon, PhD, Western Universiy
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 1, 2019
Primary Completion (ANTICIPATED)
September 1, 2020
Study Completion (ANTICIPATED)
September 1, 2020
Study Registration Dates
First Submitted
June 27, 2019
First Submitted That Met QC Criteria
June 27, 2019
First Posted (ACTUAL)
July 2, 2019
Study Record Updates
Last Update Posted (ACTUAL)
October 2, 2019
Last Update Submitted That Met QC Criteria
September 30, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 113713
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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