Carbohydrate MetabolismNCT03682861
Effect of Glycogen Replenishment on Time Trial Performance Following a Glycogen Lowering Exercise
A study testing 20 km time trial performance and Glycogen lowering exercise in people with Carbohydrate Metabolism, run by Western University, Canada at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Carbohydrate Metabolism
- What is being tested?
- 20 km time trial performance and Glycogen lowering exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 30 Sep 2018to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Exercise Nutrition Laboratory (Western University)
London, Ontario, N6A 3K7
Peter Lemon, PhD, 519 661-2111 ext. 88139, plemon@uwo.ca
About this study
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.
Read the 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.
- Conditions
- Carbohydrate Metabolism
- Being tested
- 20 km time trial performance, Glycogen lowering exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 km time trial performanceBehavioural
20 km time trial cycling test will be conducted to measure the effect of different drinks on time
Glycogen lowering exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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 Receives: Behavioral: 20 km time trial performance; Behavioral: Glycogen lowering exercise |
| Carbohydrate drinks | Experimental | 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 Receives: Behavioral: 20 km time trial performance; Behavioral: Glycogen lowering exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
20 km time trial
participants will ride for 20 km on a stationary bike and time to finish will be measured
Measured: 40 minutes
Secondary outcomes (5)
VO2
VO2 will be measured using a metabolic cart
Measured: 2 hours
Blood glucose
glucose will be measured using glucometer
Measured: 2 hours
VCO2
VCO2 will be measured using a metabolic cart
Measured: 2 hours
Serum insulin
Insulin will be measured using an immumoassay kit
Measured: 2 hours
Blood lactate
blood lactate will be measured using lactate meter
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start30 Sep 2018
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carbohydrate MetabolismStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- It is a repeated measure design where each participant will undergo all four treatment in a randomized fashion to prevent any order effect. Treatments (recovery drinks) include a placebo which will be similar in taste and flavour to other treatments and three carbohydrate containing drinks mixed in water at different concentrations. Design of the study is composed of three main stages: 1) glycogen lowering exercise, 2) glycogen replenishment and rest and 3) performance based, timed cycling exercise. All participants will arrive fasted to the laboratory, performing an exercise protocol that lowers their glycogen levels, followed by ingestion of different drinks (every 30 min) during 2 hours of a 4 hour rest and finally performing a 20 km stationary bike test for the time to finish to evaluate the effect of recovery drinks ingested.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Lemon, Western University, Canada
- Investigators
- Peter Lemon, PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682861
- Sponsor's protocol ID
- 112747
- Status last verified
- Dec 2018
- First submitted
- 21 Sep 2018
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 9694422Upshaw 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.
PubMed 26314086
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Glycogen Replenishment on Time Trial Performance Following a Glycogen Lowering Exercise
- ClinicalTrials.gov ID
- NCT03682861
- Acronym / sponsor ID
- 112747
- Conditions
- Carbohydrate Metabolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 30 Sep 2018 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- It is a repeated measure design where each participant will undergo all four treatment in a randomized fashion to prevent any order effect. Treatments (recovery drinks) include a placebo which will be similar in taste and flavour to other treatments and three carbohydrate containing drinks mixed in water at different concentrations. Design of the study is composed of three main stages: 1) glycogen lowering exercise, 2) glycogen replenishment and rest and 3) performance based, timed cycling exercise. All participants will arrive fasted to the laboratory, performing an exercise protocol that lowers their glycogen levels, followed by ingestion of different drinks (every 30 min) during 2 hours of a 4 hour rest and finally performing a 20 km stationary bike test for the time to finish to evaluate the effect of recovery drinks ingested.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Behavioral: 20 km time trial performance, Behavioral: Glycogen lowering exercisePlacebo flavored drink similar to treatments but with no energy will be ingested post glycogen lowering exercise, followed by a 20 km time trial intervention |
| Carbohydrate drinks | Experimental | Behavioral: 20 km time trial performance, Behavioral: Glycogen lowering exerciseSweet 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 20 km time trial performance20 km time trial cycling test will be conducted to measure the effect of different drinks on time | Behavioural | Carbohydrate drinks, Placebo |
| Glycogen lowering exerciseGlycogen 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. | Behavioural | Carbohydrate drinks, Placebo |
Primary outcome
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
5 secondary outcomes
VO2
Time frame: 2 hours
Blood glucose
Time frame: 2 hours
VCO2
Time frame: 2 hours
Serum insulin
Time frame: 2 hours
Blood lactate
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Results publication: PubMed 9694422Ivy 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.
- Results publication: PubMed 26314086Upshaw 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.
- Individual participant dataSharing planned: No
Related trials for Carbohydrate Metabolism
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Natural History of Glycosphingolipid Storage Disorders and Glycoprotein Disorders
Neurological Regression, Myoclonus
RecruitingObservational study
Clinical and Basic Investigations Into Known and Suspected Congenital Disorders of Glycosylation
Congenital Disorders of Glycosylation
Recruiting
C-Carbs: A CGM-guided Approach to Teaching Carb Awareness
Type 1 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Lemon, PhD principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 20 km time trial performance and Glycogen lowering exercise in people with Carbohydrate Metabolism, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Lemon, PhD (519 6612111 ext. 88139, plemon@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
20 km time trial (time frame: 40 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03682861, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2018.