Ketone Supplementation, Glycogen Replenishment and Time Trial Performance Following Glycogen Lowering Exercise

NCT04004676 | Unknown

• 1 other identifier: 113713
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Ketones; Glycogen replenishment; Exercise Performance

Outcome Measures

Primary Outcomes (1)

• 20 km cycling time trial

  participants will ride for 20 km on a stationary bike and time to finish will be measured

  40 minutes

Secondary Outcomes (3)

• Blood insulin

  2 hours

• Blood Lactate

  45 minutes

• Blood Ketones

  2 hours

Study Arms (2)

Placebo

ACTIVE COMPARATOR

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

Behavioral: 20 km time trial performance; Behavioral: Glycogen lowering exercise

Ketone_CHO

EXPERIMENTAL

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

Behavioral: 20 km time trial performance; Behavioral: Glycogen lowering exercise

Interventions

20 km time trial performance BEHAVIORAL

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

Ketone_CHO; Placebo

Glycogen lowering exercise BEHAVIORAL

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.

Ketone_CHO; Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

Exercise Nutrition Laboratory (Western University)

London, Ontario, N6A 3K7, Canada

RECRUITING

MeSH Terms

Conditions

Ketosis

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Peter Lemon, PhD

  Western Universiy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Lemon, PhD

CONTACT

519 6612111; plemon@uwo.ca

Manuel Quinones, MSc

CONTACT

519 6612111; mquinon2@uwo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 2, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 2, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)