Recruiting

Ketone Supplementation

Sponsor:

Western University, Canada

Code:

NCT04004676

Conditions

Ketonemia

Exercise Performance

Ketosis

Eligibility Criteria

Sex: Male

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

20 km time trial performance

Glycogen lowering exercise

Study Details

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.

Conditions

Ketonemia

Exercise Performance

Ketosis

Study ID

NCT04004676

Start date

Sep 1, 2019

Status verified date

Sep, 2019

Completion date

Sep 1, 2020

Anticipated

Primary completion date

Sep 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 40

Healthy Volunteers: Accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Placebo

isocaloric carbohydrate - only containing drink will be ingested post glycogen lowering exercise, followed by a 20 km time trial intervention

experimental: Ketone CHO

Ketone - Carbohydrate supplementation will be ingested post glycogen lowering exercise, followed by a 20 km time trial intervention

Interventions

20 km time trial performance

20 km time trial cycling test will be conducted to measure the effect of different drinks on performance time

Glycogen lowering exercise

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

  • 20 km cycling time trial [ Time Frame: 40 minutes ]

Central Contacts and Locations

Central contacts

Peter Lemon, PhD

519 6612111plemon@uwo.ca

Manuel Quinones, MSc

519 6612111mquinon2@uwo.ca

Locations

Exercise Nutrition Laboratory (Western University)

Recruiting

London, Ontario, Canada, N6A 3K7

Contacts

Peter Lemon, PhD

519 6612111plemon@uwo.ca

More Information

Sponsor

Western University, Canada

Last update posted

Oct 2, 2019

Last verified

Sep, 2019

Keywords

  • Ketones
  • Glycogen replenishment
  • Exercise Performance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Western University, Canada on 2019-10-02.