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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04004676
Other study ID # 113713
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date September 1, 2020

Study information

Verified date September 2019
Source Western University, Canada
Contact Peter Lemon, PhD
Phone 519 6612111
Email plemon@uwo.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date September 1, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility 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


Related Conditions & MeSH terms


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
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.

Locations

Country Name City State
Canada Exercise Nutrition Laboratory (Western University) London Ontario

Sponsors (1)

Lead Sponsor Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Blood insulin insulin in blood will be measured using ELISA kits 2 hours
Secondary Blood Lactate blood lactate will be measured using lactate meter 45 minutes
Secondary Blood Ketones Ketones in blood will be measured using ketone meter 2 hours
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