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

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ClinicalTrials.gov Identifier: NCT04004676
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Peter Lemon, Western University, Canada

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.

Condition or disease Intervention/treatment Phase
Ketonemia Exercise Performance Ketosis Behavioral: 20 km time trial performance Behavioral: Glycogen lowering exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Double (Participant, Investigator)
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
Primary Purpose: Other
Official Title: Effect of Ketone Supplementation on Glycogen Replenishment and Time Trial Performance Following Glycogen Lowering Exercise
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


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

Behavioral: 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.

Experimental: Ketone_CHO
Ketone - Carbohydrate supplementation will be ingested post glycogen lowering exercise, followed by a 20 km time trial intervention
Behavioral: 20 km time trial performance
20 km time trial cycling test will be conducted to measure the effect of different drinks on performance time

Behavioral: 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 Measures :
  1. 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


Secondary Outcome Measures :
  1. Blood insulin [ Time Frame: 2 hours ]
    insulin in blood will be measured using ELISA kits

  2. Blood Lactate [ Time Frame: 45 minutes ]
    blood lactate will be measured using lactate meter

  3. Blood Ketones [ Time Frame: 2 hours ]
    Ketones in blood will be measured using ketone meter



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04004676


Contacts
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Contact: Peter Lemon, PhD 519 6612111 ext 88139 plemon@uwo.ca
Contact: Manuel Quinones, MSc 519 6612111 ext 88139 mquinon2@uwo.ca

Locations
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Canada, Ontario
Exercise Nutrition Laboratory (Western University) Recruiting
London, Ontario, Canada, N6A 3K7
Contact: Peter Lemon, PhD    519 6612111 ext 88139    plemon@uwo.ca   
Sponsors and Collaborators
Western University, Canada
Investigators
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Principal Investigator: Peter Lemon, PhD Western Universiy
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Responsible Party: Peter Lemon, Professor, Western University, Canada
ClinicalTrials.gov Identifier: NCT04004676    
Other Study ID Numbers: 113713
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peter Lemon, Western University, Canada:
Ketones
Glycogen replenishment
Exercise Performance
Additional relevant MeSH terms:
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Ketosis
Acidosis
Acid-Base Imbalance
Metabolic Diseases