Clinical trial NCT04004676: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Ketonemia
Exercise Performance
Ketosis
Keywords: Ketones
Glycogen replenishment
Exercise Performance
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: 20 km cycling time trial
timeFrame: 40 minutes
Secondary outcomes:
measure: Blood insulin
timeFrame: 2 hours
measure: Blood Lactate
timeFrame: 45 minutes
measure: Blood Ketones
timeFrame: 2 hours
Other outcomes:
Locations:
city: London
country: Canada
facility: Exercise Nutrition Laboratory (Western University)
state: Ontario
Study officials:
affiliation: Western Universiy
name: Peter Lemon, PhD
role: PRINCIPAL_INVESTIGATOR
References: