KetonemiaNCT03895892
Exogenous Ketone Supplementation and Exercise Performance
A study testing 20 km time trial, Wingate test and Ketone/Caffeine in people with Ketonemia and Ketosis, run by Western University, Canada at 1 site in Canada.
Trial summary
20 healthy recreationally active men and woman aged 18-35 will participate in the study. There will be three treatments involved: Caffeinated ketone supplements, non-caffeinated ketone supplement and water-placebo. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- What is being tested?
- 20 km time trial, Wingate test and Ketone/Caffeine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 15 May 2019to Dec 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female recreationally active individuals
- aged 15-35 years
- non regular caffeine users.
Who cannot join
- Smoker
- Taking part in other research
- Sedentary
- For women, if they are pregnant or become pregnant during the study
- Injury limiting exercise ability.
- Have symptoms or take medication for respiratory disease
Show all 10Show fewer
- Have symptoms or take medication for cardiovascular 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
Trial locations and contacts
1 site in 1 country.
Manuel D Quinones, MSc contact
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: The Effect of Exogenous Ketone Supplementation on 20 km Time Trial and Wingate Performance in Recreationally Active Individuals
20 healthy recreationally active men and woman aged 18-35 will participate in the study. There will be three treatments involved: Caffeinated ketone supplements, non-caffeinated ketone supplement and water-placebo. Participants will complete the protocol three times and the treatment order will be systematically rotated to avoid any order effect. The three main trials will be separated by at least 1 week. After providing the corresponding treatment, participants will be given 30 minutes and after, they will perform a standardized 10-minute warm-up, followed by the 20 km time trial and a 30-second all-out Wingate test.
Read the detailed description
Some researchers support that a state of ketosis, reached through the use of ketogenic diet, has the potential to improve athletic. To attain such state, individuals must restrict carbohydrate intake to a maximum of 50g/ day or 10% while keeping protein intake moderate. One of the biggest challenges to achieve and maintain ketosis is complying with the diet due to its restrictive nature. Consequently, manufacturers have developed supplements that can induce a state of ketosis acutely (~1 hour). Unfortunately, there is very little evidence supporting the use of these supplements to enhance athletic performance. Hyperketonemia (blood ketone concentration > 0.2 Mm) seems to elevate the rate of utilization of ketone bodies. These changes in substrate utilization may allow athletes to preserve, something that would be advantageous for exercise performance. Ketone salts have been shown to elevate the concentration of ketones in blood and as such they may allow the body benefit from the apparent sparing of carbohydrates. Manufacturers now provide ketones salts combined with other ingredients such as caffeine. However it is unknown whether or not the addition of these ingredients has any positive or negative effect on athletic performance. Caffeine alone has been shown to improve athletic performance in several studies. Therefore, the purpose of this study is to compare the effectiveness of a caffeine free ketone salt supplement vs a caffeinated ketone salt supplement and their effects on a 20km time trial and a 30 second all-out Wingate test.
- Being tested
- 20 km time trial, Wingate test, Ketone/Caffeine, Ketone, Water Placebo
- 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 trialBehavioural
20 km time trial cycling test will be conducted to measure the effect of different drinks on time
Wingate testBehavioural
30 second all-out effort on a bike will be conducted to measure the effect of different drinks on peak power output
Ketone/CaffeineDietary supplement
Dietary supplement containing ketone salts and caffeine
KetoneDietary supplement
Dietary supplement containing only ketone salts
Water PlaceboDietary supplement
Dietary supplement containing only water
| Study group | Role | What they receive |
|---|---|---|
| Water Placebo | Placebo comparator | Placebo flavored drink similar to treatments but with no energy will be ingested before completing a 20km Time trial and a 30 second all-out Wingate test Receives: Behavioral: 20 km time trial; Behavioral: Wingate test; Dietary Supplement: Water Placebo |
| Experimental 1 | Experimental | Ketone salts supplement mixed in water will be ingested before completing a 20km Time trial and a 30 second all-out Wingate test Receives: Behavioral: 20 km time trial; Behavioral: Wingate test; Dietary Supplement: Ketone |
| Experimental 2 | Experimental | Ketone salts/caffeine supplement mixed in water will be ingested before completing a 20km Time trial and a 30 second all-out Wingate test Receives: Behavioral: 20 km time trial; Behavioral: Wingate test; Dietary Supplement: Ketone/Caffeine |
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 complete distance will be measured.
Measured: 40 minutes
Wingate test
participants will perform a ver short all-out effort on a stationary bike. peak power output and fatigue index will be measured.
Measured: 30 seconds
Secondary outcomes (3)
Blood Ketone
blood ketones will be measured using ketone meter
Measured: 1 hour
Blood Lactate
blood lactate will be measured using lactate meter
Measured: 1 hour
Rates of perceived exertion (RPE)
RPE will be measured using Borg's scale (1= low - 10= high).
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start15 May 2019
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (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 three treatments involved: Caffeinated ketone supplements, non-caffeinated ketone supplement and water-placebo. Participants will complete the protocol three times and the treatment order will be systematically rotated to avoid any order effect. Design of the study is composed of two performance tests 30 minutes following supplementation. All participants will arrive in a fed state to the laboratory. the corresponding treatment will be provided and 30 minutes later, they will perform a 20 km time trial. 10 minutes after the time trial, participants will perform a 30 second all-out Wingate test.
- 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 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895892
- Sponsor's protocol ID
- 113474
- Status last verified
- Sep 2019
- First submitted
- 13 Feb 2019
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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
- The Effect of Exogenous Ketone Supplementation on 20 km Time Trial and Wingate Performance in Recreationally Active Individuals
- ClinicalTrials.gov ID
- NCT03895892
- Acronym / sponsor ID
- 113474
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 29 Mar 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 recreationally active men and woman aged 18-35 will participate in the study. There will be three treatments involved: Caffeinated ketone supplements, non-caffeinated ketone supplement and water-placebo. Participants will complete the protocol three times and the treatment order will be systematically rotated to avoid any order effect. The three main trials will be separated by at least 1 week. After providing the corresponding treatment, participants will be given 30 minutes and after, they will perform a standardized 10-minute warm-up, followed by the 20 km time trial and a 30-second all-out Wingate test.
Detailed description
Some researchers support that a state of ketosis, reached through the use of ketogenic diet, has the potential to improve athletic. To attain such state, individuals must restrict carbohydrate intake to a maximum of 50g/ day or 10% while keeping protein intake moderate. One of the biggest challenges to achieve and maintain ketosis is complying with the diet due to its restrictive nature. Consequently, manufacturers have developed supplements that can induce a state of ketosis acutely (~1 hour). Unfortunately, there is very little evidence supporting the use of these supplements to enhance athletic performance. Hyperketonemia (blood ketone concentration > 0.2 Mm) seems to elevate the rate of utilization of ketone bodies. These changes in substrate utilization may allow athletes to preserve, something that would be advantageous for exercise performance. Ketone salts have been shown to elevate the concentration of ketones in blood and as such they may allow the body benefit from the apparent sparing of carbohydrates. Manufacturers now provide ketones salts combined with other ingredients such as caffeine. However it is unknown whether or not the addition of these ingredients has any positive or negative effect on athletic performance. Caffeine alone has been shown to improve athletic performance in several studies. Therefore, the purpose of this study is to compare the effectiveness of a caffeine free ketone salt supplement vs a caffeinated ketone salt supplement and their effects on a 20km time trial and a 30 second all-out Wingate test.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This will be a double blind repeated measures cross over study. There will be three treatments involved: Caffeinated ketone supplements, non-caffeinated ketone supplement and water-placebo. Participants will complete the protocol three times and the treatment order will be systematically rotated to avoid any order effect. Design of the study is composed of two performance tests 30 minutes following supplementation. All participants will arrive in a fed state to the laboratory. the corresponding treatment will be provided and 30 minutes later, they will perform a 20 km time trial. 10 minutes after the time trial, participants will perform a 30 second all-out Wingate test.
| Arm | Type | Receives |
|---|---|---|
| Water Placebo | Placebo comparator | Behavioral: 20 km time trial, Behavioral: Wingate test, Dietary Supplement: Water PlaceboPlacebo flavored drink similar to treatments but with no energy will be ingested before completing a 20km Time trial and a 30 second all-out Wingate test |
| Experimental 1 | Experimental | Behavioral: 20 km time trial, Behavioral: Wingate test, Dietary Supplement: KetoneKetone salts supplement mixed in water will be ingested before completing a 20km Time trial and a 30 second all-out Wingate test |
| Experimental 2 | Experimental | Behavioral: 20 km time trial, Behavioral: Wingate test, Dietary Supplement: Ketone/CaffeineKetone salts/caffeine supplement mixed in water will be ingested before completing a 20km Time trial and a 30 second all-out Wingate test |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and female recreationally active individuals
- aged 15-35 years
- non regular caffeine users.
Key exclusion criteria (10 listed)
- Smoker
- Taking part in other research
- Sedentary
- For women, if they are pregnant or become pregnant during the study
- Injury limiting exercise ability.
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 trial20 km time trial cycling test will be conducted to measure the effect of different drinks on time | Behavioural | Experimental 1, Experimental 2, Water Placebo |
| Wingate test30 second all-out effort on a bike will be conducted to measure the effect of different drinks on peak power output | Behavioural | Experimental 1, Experimental 2, Water Placebo |
| Ketone/CaffeineDietary supplement containing ketone salts and caffeine | Dietary supplement | Experimental 2 |
| KetoneDietary supplement containing only ketone salts | Dietary supplement | Experimental 1 |
| Water PlaceboDietary supplement containing only water | Dietary supplement | Water Placebo |
Primary outcome
20 km time trial
Time frame: 40 minutes
participants will ride for 20 km on a stationary bike and time to complete distance will be measured.
Wingate test
Time frame: 30 seconds
participants will perform a ver short all-out effort on a stationary bike. peak power output and fatigue index will be measured.
3 secondary outcomes
Blood Ketone
Time frame: 1 hour
Blood Lactate
Time frame: 1 hour
Rates of perceived exertion (RPE)
Time frame: 1 hour
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.
Manuel D Quinones, MSc contact
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, Wingate test and Ketone/Caffeine in people with Ketonemia and Ketosis, 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 3 inclusion and 10 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. 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). The study lists 2 primary outcomes in all. 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.