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出境医 / 临床实验 / Ketone Supplementation, Glycogen Replenishment and Time Trial Performance Following Glycogen Lowering Exercise
Ketone Supplementation, Glycogen Replenishment and Time Trial Performance Following Glycogen Lowering Exercise
Study Description
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.
Study Design
| 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 |
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures :
- 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 :
- Blood insulin [ Time Frame: 2 hours ]insulin in blood will be measured using ELISA kits
- Blood Lactate [ Time Frame: 45 minutes ]blood lactate will be measured using lactate meter
- Blood Ketones [ Time Frame: 2 hours ]Ketones in blood will be measured using ketone meter
Eligibility Criteria
| 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
Contacts and Locations
Contacts
| Contact: Peter Lemon, PhD | 519 6612111 ext 88139 | plemon@uwo.ca | |
| Contact: Manuel Quinones, MSc | 519 6612111 ext 88139 | mquinon2@uwo.ca |
Locations
| 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
| Principal Investigator: | Peter Lemon, PhD | Western Universiy |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 27, 2019 | ||||||||
| First Posted Date ICMJE | July 2, 2019 | ||||||||
| Last Update Posted Date | October 2, 2019 | ||||||||
| Actual Study Start Date ICMJE | September 1, 2019 | ||||||||
| Estimated Primary Completion Date | September 1, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Ketone Supplementation, Glycogen Replenishment and Time Trial Performance Following Glycogen Lowering Exercise | ||||||||
| Official Title ICMJE | Effect of Ketone Supplementation on Glycogen Replenishment and Time Trial Performance Following Glycogen Lowering Exercise | ||||||||
| 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. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | 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
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
20 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | September 1, 2020 | ||||||||
| Estimated Primary Completion Date | September 1, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 40 Years (Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Canada | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04004676 | ||||||||
| Other Study ID Numbers ICMJE | 113713 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Peter Lemon, Western University, Canada | ||||||||
| Study Sponsor ICMJE | Western University, Canada | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Western University, Canada | ||||||||
| Verification Date | September 2019 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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