- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03682861
Effect of Glycogen Replenishment on Time Trial Performance Following a Glycogen Lowering Exercise
December 3, 2018 updated by: Peter Lemon, Western University, Canada
Fifteen endurance-trained male/female will be randomly assigned to do four exercise and nutrition trials involving ingestion of four different concentrations of sweet corn derived starch (food component) in water (0, 1, 1.5 and 2 g. kg-1.
h-1).
Each trial will be separated by at least one week.
During these four experimental trials athletes will be subjected to a glycogen-lowering cycling exercise protocol followed by a 4-h post-exercise recovery period (2h feeding then 2 hours of rest).
At the end of 4-h period they will do a 20 kilometre time trial test on a stationary bike in a laboratory condition to measure the effect of different glycogen repletion rates on exercise performance.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Post-exercise glycogen synthesis rate is an important factor in determining the time needed to recover.
Glycogen synthesis is affected not only by the extent of glycogen depletion but also in a more direct manner by the type, duration, and intensity of the preceding exercise because these will differentially influence the acute enzymatic changes as well as recovery from the acute changes that are induced by strenuous exercise.
To optimize glycogen synthesis rates, adequate amounts of carbohydrate should be ingested.
It has been suggested initially that a carbohydrate intake of 0.35 g·kg body wt-1 ·h-1 , provided at 2-h intervals, maximized muscle glycogen synthesis.
Others observed no differences in glycogen storage rates after subjects ingested 0.75 or 1.5 g carbohydrate·kg-1 · h-1 provided at 2-h intervals.
In a follow-up study, it was reported that an intake of >0.5 g·kg-1 · h-1 is necessary to maximize post-exercise glycogen synthesis if supplements are administered at 2-h intervals.
Higher glycogen synthesis rates have been reported in studies in which carbohydrates were ingested more frequently and at higher ingestion rates than in previous studies.
Other efforts to increase glycogen synthesis rates by changing the form of administration (ie, as a solution, as a solid, or intravenously) have been unsuccessful.
While the above range of intake rates has been suggested to maximize muscle glycogen resynthesis post-exercise, the required dosage with sweet corn derived high glycemic starch and its effect on a subsequent time trial exercise is currently unknown.
So, investigators objective in this experiment is to find out optimal sweet corn derived recovery ingestion dose by using a glycogen lowering exercise protocol, followed by glycogen repletion via ingestion and a subsequent 20 km time trial cycling performance.
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Arash Bandegan, PhD
- Phone Number: 88139 519 6612111
- Email: abandeg@uwo.ca
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 3K7
- Recruiting
- Exercise Nutrition Laboratory (Western University)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- are a healthy male or female endurance athlete of 18- 40 years of age
- have ≥2 y endurance training experience; training for ˃1 h/day
Exclusion Criteria:
- Have symptoms or take medication for respiratory disease
- Have symptoms or take medication for cardiovascular disease
- Have symptoms or take medication for metabolic disease
- Have symptoms or take mediation for neuromuscular disease
- Use heart rate or blood pressure medications
- Use any medications with side effects of dizziness, lack of motor control, or slowed reaction time
- Have any cardiovascular or neuromuscular limitations to exercise
- Are pregnant or find out that you are pregnant during experiment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo flavored drink similar to treatments but with no energy will be ingested post glycogen lowering exercise, followed by a 20 km time trial intervention
|
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.
20 km time trial cycling test will be conducted to measure the effect of different drinks on time
|
Experimental: Carbohydrate drinks
Sweet corn derived starch mixed in water at three different concentrations (6%, 12% and 18%) will be ingested post glycogen lowering exercise, followed by a 20 km time trial intervention
|
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.
20 km time trial cycling test will be conducted to measure the effect of different drinks on time
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
20 km time trial
Time Frame: 40 minutes
|
participants will ride for 20 km on a stationary bike and time to finish will be measured
|
40 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VO2
Time Frame: 2 hours
|
VO2 will be measured using a metabolic cart
|
2 hours
|
Blood glucose
Time Frame: 2 hours
|
glucose will be measured using glucometer
|
2 hours
|
VCO2
Time Frame: 2 hours
|
VCO2 will be measured using a metabolic cart
|
2 hours
|
Serum insulin
Time Frame: 2 hours
|
Insulin will be measured using an immumoassay kit
|
2 hours
|
Blood lactate
Time Frame: 2 hours
|
blood lactate will be measured using lactate meter
|
2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ivy JL. Glycogen resynthesis after exercise: effect of carbohydrate intake. Int J Sports Med. 1998 Jun;19 Suppl 2:S142-5. doi: 10.1055/s-2007-971981.
- Upshaw AU, Wong TS, Bandegan A, Lemon PW. Cycling Time Trial Performance 4 Hours After Glycogen-Lowering Exercise Is Similarly Enhanced by Recovery Nondairy Chocolate Beverages Versus Chocolate Milk. Int J Sport Nutr Exerc Metab. 2016 Feb;26(1):65-70. doi: 10.1123/ijsnem.2015-0056. Epub 2015 Aug 27.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 30, 2018
Primary Completion (Anticipated)
September 30, 2019
Study Completion (Anticipated)
September 30, 2019
Study Registration Dates
First Submitted
September 21, 2018
First Submitted That Met QC Criteria
September 21, 2018
First Posted (Actual)
September 25, 2018
Study Record Updates
Last Update Posted (Actual)
December 5, 2018
Last Update Submitted That Met QC Criteria
December 3, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 112747
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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