KetonemiaNCT04576026
Exogenous Ketone Supplementation and Cognitive Function During Exercise
A study testing mental fatiguing task, 45 - minute simulated soccer game and cognitive function in people with Ketonemia and Mental Fatigue, run by Western University, Canada at 1 site in Canada.
Trial summary
15 healthy trained males will volunteer to participate in this study. there will be 2 treatments: Ketone esters supplementation and iso-caloric carbohydrate. The purpose of this study is to evaluate the effect of ketone esters on cognitive function during exercise after induced mental fatigue Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ketonemia, Mental Fatigue, Ketosis
- What is being tested?
- mental fatiguing task, 45 - minute simulated soccer game and cognitive function
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2020to 1 Oct 2021
- 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 35 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 recreationally active individual, 18-35 year old.
Who cannot join
- You will be excluded from this study if you:
- Are not involved in regular exercise (at least 2x week)
- 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.
Show all 11Show fewer
- Have a history of concussion/head injuries.
- Have an excessive alcohol intake (>2 drinks/day)
- Are consuming a ketogenic diet (for at least 2 weeks)
- Are a smoker
- Cannabis use is not a exclusion criteria; however, it must be avoided on experimental days.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Exercise Nutrition Laboratory, Western University
London, Ontario, N6A3K7
Peter WR Lemon, PhD, 5196612111 ext. 88139, plemon@uwo.ca
About this study
Official title: Effect of Exogenous Ketone Supplementation on Cognitive Function During Exercise After Induced Mental Fatigue
15 healthy trained males will volunteer to participate in this study. there will be 2 treatments: Ketone esters supplementation and iso-caloric carbohydrate. The purpose of this study is to evaluate the effect of ketone esters on cognitive function during exercise after induced mental fatigue
Read the detailed description
mental fatigue is often seen in sports of moderate to long duration. its onset is associated with detriments in cognitive function which leads to poor decision making and detriments in specific sport skills. Ketones can serve as a powerful brain fuel source so they may have the potential to delay/ revert the onset of mental fatigue. in this experiment, we will induce mental fatigue in individuals who will be performing 45 minutes of intermittent exercise right after. During exercise cognitive function will be measured under 2 condition, Ketone supplementation and placebo. The purpose of this study is to see if ketones can play a role in reverting that initial mental fatigue during exercise, compared to placebo.
- Conditions
- Ketonemia, Mental Fatigue, Ketosis
- Being tested
- mental fatiguing task, 45 - minute simulated soccer game, cognitive function
- Keywords
- Ketone supplements, Cognitive function, Exercise
- Medical subject headings
- Ketosis, Mental Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mental fatiguing taskBehavioural
a 30-minute computerized Stroop test will be used to induce mental fatigue before exercise intervention
45 - minute simulated soccer gameBehavioural
an intermittent running protocol using intensities and speeds seen in soccer will be used to simulate the physiological demands of the sport
cognitive functionBehavioural
The Stroop test and a complex reaction time test will be used to assess cognitive function during exercise.
| Study group | Role | What they receive |
|---|---|---|
| Ketone esters | Experimental | Ketone esters will be given to mentally fatigued individuals, prior to a 45 minute simulated soccer game in which cognitive function will be assessed. Receives: Behavioral: mental fatiguing task; Behavioral: 45 - minute simulated soccer game; Behavioral: cognitive function |
| Placebo | Active comparator | Iso-caloric carbohydrate drink will be given to mentally fatigued individuals, prior to a 45 minute simulated soccer game in which cognitive function will be assessed. Receives: Behavioral: mental fatiguing task; Behavioral: 45 - minute simulated soccer game; Behavioral: cognitive function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
participants will be doing the Stroop test and a complex reaction test during exercise.
Measured: 30 minutes
Secondary outcomes (3)
Blood Ketones
Ketones in blood will be measured using a ketone meter
Measured: 45 minutes
Blood Glucose
blood glucose will be measured using a glucometer
Measured: 45 minutes
Blood Lactate
blood lactate will be measured using a lactate meter
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2021 (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.
- 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: Ketone esters supplements and iso-caloric carbohydrates (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 mental fatiguing task, followed by a 45 minute simulated soccer game (second half). Cognitive function will be assessed during the 45 minutes of exercise. All participants will perform the protocol in a fed state (4 h after consumption of their last meal)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- 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 WR Lemon, PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576026
- Sponsor's protocol ID
- 116711
- Status last verified
- Sep 2020
- First submitted
- 29 Sep 2020
- Last updated
- 5 Oct 2020
- 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 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exogenous Ketone Supplementation on Cognitive Function During Exercise After Induced Mental Fatigue
- ClinicalTrials.gov ID
- NCT04576026
- Acronym / sponsor ID
- 116711
- Conditions
- Ketonemia, Mental Fatigue, Ketosis
- Keywords
- Ketone supplements, Cognitive function, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 5 Oct 2020 (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.
15 healthy trained males will volunteer to participate in this study. there will be 2 treatments: Ketone esters supplementation and iso-caloric carbohydrate. The purpose of this study is to evaluate the effect of ketone esters on cognitive function during exercise after induced mental fatigue
Detailed description
mental fatigue is often seen in sports of moderate to long duration. its onset is associated with detriments in cognitive function which leads to poor decision making and detriments in specific sport skills. Ketones can serve as a powerful brain fuel source so they may have the potential to delay/ revert the onset of mental fatigue. in this experiment, we will induce mental fatigue in individuals who will be performing 45 minutes of intermittent exercise right after. During exercise cognitive function will be measured under 2 condition, Ketone supplementation and placebo. The purpose of this study is to see if ketones can play a role in reverting that initial mental fatigue during exercise, compared to placebo.
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: Ketone esters supplements and iso-caloric carbohydrates (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 mental fatiguing task, followed by a 45 minute simulated soccer game (second half). Cognitive function will be assessed during the 45 minutes of exercise. All participants will perform the protocol in a fed state (4 h after consumption of their last meal)
| Arm | Type | Receives |
|---|---|---|
| Ketone esters | Experimental | Behavioral: mental fatiguing task, Behavioral: 45 - minute simulated soccer game, Behavioral: cognitive functionKetone esters will be given to mentally fatigued individuals, prior to a 45 minute simulated soccer game in which cognitive function will be assessed. |
| Placebo | Active comparator | Behavioral: mental fatiguing task, Behavioral: 45 - minute simulated soccer game, Behavioral: cognitive functionIso-caloric carbohydrate drink will be given to mentally fatigued individuals, prior to a 45 minute simulated soccer game in which cognitive function will be assessed. |
Who may qualify
- Ages
- 18 to 35 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 recreationally active individual, 18-35 year old.
Key exclusion criteria (11 listed)
- You will be excluded from this study if you:
- Are not involved in regular exercise (at least 2x week)
- 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
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 |
|---|---|---|
| mental fatiguing taska 30-minute computerized Stroop test will be used to induce mental fatigue before exercise intervention | Behavioural | Ketone esters, Placebo |
| 45 - minute simulated soccer gamean intermittent running protocol using intensities and speeds seen in soccer will be used to simulate the physiological demands of the sport | Behavioural | Ketone esters, Placebo |
| cognitive functionThe Stroop test and a complex reaction time test will be used to assess cognitive function during exercise. | Behavioural | Ketone esters, Placebo |
Primary outcome
Cognitive function
Time frame: 30 minutes
participants will be doing the Stroop test and a complex reaction test during exercise.
3 secondary outcomes
Blood Ketones
Time frame: 45 minutes
Blood Glucose
Time frame: 45 minutes
Blood Lactate
Time frame: 45 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- 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 WR 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 mental fatiguing task, 45 - minute simulated soccer game and cognitive function in people with Ketonemia and Mental Fatigue, 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 11 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 Oct 2020. 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 WR 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?
Cognitive function (time frame: 30 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 5 Oct 2020.