KetonemiaNCT04004676
Ketone Supplementation, Glycogen Replenishment and Time Trial Performance Following Glycogen Lowering Exercise
A study testing 20 km time trial performance and Glycogen lowering exercise in people with Ketonemia and Exercise Performance, run by Western University, Canada at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ketonemia, Exercise Performance, Ketosis
- 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?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2019to 1 Sep 2020
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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 6612111 ext. 88139, plemon@uwo.ca
About this study
Official title: Effect of Ketone Supplementation on Glycogen Replenishment and Time Trial Performance Following Glycogen Lowering Exercise
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.
Read the 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.
- Conditions
- Ketonemia, Exercise Performance, Ketosis
- Being tested
- 20 km time trial performance, Glycogen lowering exercise
- Keywords
- Ketones, Glycogen replenishment, Exercise Performance
- Medical subject headings
- Ketosis
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 performance 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 | Active comparator | isocaloric carbohydrate - only containing drink 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 |
| Ketone_CHO | Experimental | Ketone - Carbohydrate supplementation 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 cycling time trial
participants will ride for 20 km on a stationary bike and time to finish will be measured
Measured: 40 minutes
Secondary outcomes (3)
Blood insulin
insulin in blood will be measured using ELISA kits
Measured: 2 hours
Blood Lactate
blood lactate will be measured using lactate meter
Measured: 45 minutes
Blood Ketones
Ketones in blood will be measured using ketone 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 posted2 Jul 2019
- Study start1 Sep 2019
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KetonemiaStudies 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
- Crossover
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 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 Universiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004676
- Sponsor's protocol ID
- 113713
- Status last verified
- Sep 2019
- First submitted
- 27 Jun 2019
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ketone Supplementation on Glycogen Replenishment and Time Trial Performance Following Glycogen Lowering Exercise
- ClinicalTrials.gov ID
- NCT04004676
- Acronym / sponsor ID
- 113713
- Conditions
- Ketonemia, Exercise Performance, Ketosis
- Keywords
- Ketones, Glycogen replenishment, Exercise Performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 2 Jul 2019 (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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Active comparator | Behavioral: 20 km time trial performance, Behavioral: Glycogen lowering exerciseisocaloric carbohydrate - only containing drink will be ingested post glycogen lowering exercise, followed by a 20 km time trial intervention |
| Ketone_CHO | Experimental | Behavioral: 20 km time trial performance, Behavioral: Glycogen lowering exerciseKetone - Carbohydrate supplementation will be ingested post glycogen lowering exercise, followed by a 20 km time trial intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 performance time | Behavioural | Ketone_CHO, 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 | Ketone_CHO, Placebo |
Primary outcome
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
3 secondary outcomes
Blood insulin
Time frame: 2 hours
Blood Lactate
Time frame: 45 minutes
Blood Ketones
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 2 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Ketonemia
Active, not recruitingObservational study
"KETOMED: Ketonemia and Risk of Emergence Delirium in Children Undergoing General Anesthesia - A Multicenter Observational Study"
Emergence Delirium in Pediatric Anesthesia, Perioperative Ketonemia and Its Association With Recovery Outcomes in Children
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 Universiy
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 Ketonemia and Exercise Performance, 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 1 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 2 Oct 2019. 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. 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 cycling 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?
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 2 Oct 2019.