KetosisNCT03954665
Ketone Supplementation and Exercise Performance
A study testing 10 km time trial, 30s Wingate and Ketone in people with Ketosis and Exercise Performance, run by Western University, Canada at 1 site in Canada.
Trial summary
The purpose of this study is to observe the effects of exogenous ketone supplements during shorter bouts of exercise testing on twenty collegiate endurance trained athletes (18-25 years of age). Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Ketosis, Exercise Performance, Ketoses, Metabolic
- What is being tested?
- 10 km time trial, 30s Wingate and Ketone
- 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
- Sep 2019to Mar 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female Collegiate Endurance Trained Athletes
- ≥2 year training experience; ≥7 h/week
- Ages 18-25
Who cannot join
- Smoker
- Injury that will affect exercise performance
- Sedentary Behaviour
- Currently following a High Fat diet/Ketogenic diet
- Taking Beta Blockers or Hypertension Medication
- Has Respiratory, Cardiovascular and/or Neuromuscular disease that is not cleared for exercise by a physician.
Trial locations and contacts
1 site in 1 country.
Manuel D Quinones, MSc contact
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: Can Ketone Supplementation Enhance Exercise Performance?
The purpose of this study is to observe the effects of exogenous ketone supplements during shorter bouts of exercise testing on twenty collegiate endurance trained athletes (18-25 years of age).
Read the detailed description
Some believe very high fat diets (>70% energy) can enhance exercise performance by providing additional fuel (ketones) for energy metabolism, at least for very prolonged exercise (>3-4h). Regardless, this diet is difficult to maintain so it has been suggested that ingesting ketone salts along with a normal carbohydrate (CHO) diet might be more practical. The purpose of this study is to observe the effects of ketone salt ingestion on shorter term (up to ~15 min) exercise performance. Endurance trained (≥2 year training experience; ≥7 h/week) collegiate athletes (n=20) of similar body mass (♀; 55-60kg; ♂; 75-80kg) and age 18-25y) consuming 5-6g CHO•kg-1•d-1) will be tested before and after 1 and 7d of ketone salt (Prüvit, Carrollton TX, US) supplementation (0.6-0.8g•kg-1•d-1). Participants will perform two exercise performance tests (a 10km cycle time trial and a 30s Wingate cycle test on separate days) before and after supplementation. Blood samples (glucose, lactic acid, and ketone concentration) will be taken at: baseline and following each performance test. It is hypothesized that ketone salt supplementation will increase blood ketone concentration but will not enhance these exercise performance tests.
- Conditions
- Ketosis, Exercise Performance, Ketoses, Metabolic
- Being tested
- 10 km time trial, 30s Wingate, Ketone, Baseline 10 km time trial, Baseline 30s Wingate
- Keywords
- Ketones, Supplementation, 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.
10 km time trialBehavioural
10 km Cycling time trial test will be conducted to examine the effects of the Exogenous Ketone Salts on time
30s WingateBehavioural
30s all-out test to measure peak power output
KetoneDietary supplement
Supplement containing exogenous ketone salts
Baseline 10 km time trialBehavioural
A baseline 10 km Cycling time trial test will be conducted
Baseline 30s WingateBehavioural
A baseline 30s all-out test to measure peak power output
| Study group | Role | What they receive |
|---|---|---|
| Baseline Testing | Active comparator | Baseline testing for a 10km cycle time trial and a 30s Wingate cycle test. Receives: Behavioral: Baseline 10 km time trial; Behavioral: Baseline 30s Wingate |
| Dietary Supplement: Exogenous Ketone Salt | Experimental | Ketone salt supplementation (0.6-0.8g•kg-1•d-1) 7-days. Participants will perform two exercise performance tests (a 10km cycle time trial and a 30s Wingate cycle test on separate days) after supplementation. Receives: Behavioral: 10 km time trial; Behavioral: 30s Wingate; Dietary Supplement: Ketone |
What is being measured
The primary outcome is the main question the study is designed to answer.
10 km Time trial
10km time trial where participants will be measured on time to completion
Measured: 15-20 Minutes
30s Wingate
30s Wingate all out test where participants will be measured on their peak power output
Measured: 30 seconds
Secondary outcomes (3)
Blood Ketones
Blood Ketones will be measured using a ketone meter
Measured: 1-2 hours
Blood Glucose
Blood Glucose will be measured using a Blood glucose meter
Measured: 1-2 hours
Blood Lactate
Blood Lactate will be measured using a lactate meter
Measured: 1-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study startSep 2019 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for KetosisStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter WR Lemon, PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954665
- Sponsor's protocol ID
- 113761
- Status last verified
- Apr 2019
- First submitted
- 6 May 2019
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Waldman HS, Basham SA, Price FG, Smith JW, Chander H, Knight AC, Krings BM, McAllister MJ. Exogenous ketone salts do not improve cognitive responses after a high-intensity exercise protocol in healthy college-aged males. Appl Physiol Nutr Metab. 2018 Jul;43(7):711-717. doi: 10.1139/apnm-2017-0724. Epub 2018 Feb 16.
PubMed 29451991O'Malley T, Myette-Cote E, Durrer C, Little JP. Nutritional ketone salts increase fat oxidation but impair high-intensity exercise performance in healthy adult males. Appl Physiol Nutr Metab. 2017 Oct;42(10):1031-1035. doi: 10.1139/apnm-2016-0641. Epub 2017 Jul 27.
PubMed 28750585Volek JS, Noakes T, Phinney SD. Rethinking fat as a fuel for endurance exercise. Eur J Sport Sci. 2015;15(1):13-20. doi: 10.1080/17461391.2014.959564. Epub 2014 Oct 2.
PubMed 25275931
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Ketone Supplementation Enhance Exercise Performance?
- ClinicalTrials.gov ID
- NCT03954665
- Acronym / sponsor ID
- 113761
- Conditions
- Ketosis, Exercise Performance, Ketoses, Metabolic
- Keywords
- Ketones, Supplementation, Exercise Performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 17 May 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.
The purpose of this study is to observe the effects of exogenous ketone supplements during shorter bouts of exercise testing on twenty collegiate endurance trained athletes (18-25 years of age).
Detailed description
Some believe very high fat diets (>70% energy) can enhance exercise performance by providing additional fuel (ketones) for energy metabolism, at least for very prolonged exercise (>3-4h). Regardless, this diet is difficult to maintain so it has been suggested that ingesting ketone salts along with a normal carbohydrate (CHO) diet might be more practical. The purpose of this study is to observe the effects of ketone salt ingestion on shorter term (up to ~15 min) exercise performance. Endurance trained (≥2 year training experience; ≥7 h/week) collegiate athletes (n=20) of similar body mass (♀; 55-60kg; ♂; 75-80kg) and age 18-25y) consuming 5-6g CHO•kg-1•d-1) will be tested before and after 1 and 7d of ketone salt (Prüvit, Carrollton TX, US) supplementation (0.6-0.8g•kg-1•d-1). Participants will perform two exercise performance tests (a 10km cycle time trial and a 30s Wingate cycle test on separate days) before and after supplementation. Blood samples (glucose, lactic acid, and ketone concentration) will be taken at: baseline and following each performance test. It is hypothesized that ketone salt supplementation will increase blood ketone concentration but will not enhance these exercise performance tests.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline Testing | Active comparator | Behavioral: Baseline 10 km time trial, Behavioral: Baseline 30s WingateBaseline testing for a 10km cycle time trial and a 30s Wingate cycle test. |
| Dietary Supplement: Exogenous Ketone Salt | Experimental | Behavioral: 10 km time trial, Behavioral: 30s Wingate, Dietary Supplement: KetoneKetone salt supplementation (0.6-0.8g•kg-1•d-1) 7-days. Participants will perform two exercise performance tests (a 10km cycle time trial and a 30s Wingate cycle test on separate days) after supplementation. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male or female Collegiate Endurance Trained Athletes
- ≥2 year training experience; ≥7 h/week
- Ages 18-25
Key exclusion criteria (6 listed)
- Smoker
- Injury that will affect exercise performance
- Sedentary Behaviour
- Currently following a High Fat diet/Ketogenic diet
- Taking Beta Blockers or Hypertension Medication
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 |
|---|---|---|
| 10 km time trial10 km Cycling time trial test will be conducted to examine the effects of the Exogenous Ketone Salts on time | Behavioural | Dietary Supplement: Exogenous Ketone Salt |
| 30s Wingate30s all-out test to measure peak power output | Behavioural | Dietary Supplement: Exogenous Ketone Salt |
| KetoneSupplement containing exogenous ketone salts | Dietary supplement | Dietary Supplement: Exogenous Ketone Salt |
| Baseline 10 km time trialA baseline 10 km Cycling time trial test will be conducted | Behavioural | Baseline Testing |
| Baseline 30s WingateA baseline 30s all-out test to measure peak power output | Behavioural | Baseline Testing |
Primary outcome
10 km Time trial
Time frame: 15-20 Minutes
10km time trial where participants will be measured on time to completion
30s Wingate
Time frame: 30 seconds
30s Wingate all out test where participants will be measured on their peak power output
3 secondary outcomes
Blood Ketones
Time frame: 1-2 hours
Blood Glucose
Time frame: 1-2 hours
Blood Lactate
Time frame: 1-2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Background: PubMed 29451991Waldman HS, Basham SA, Price FG, Smith JW, Chander H, Knight AC, Krings BM, McAllister MJ. Exogenous ketone salts do not improve cognitive responses after a high-intensity exercise protocol in healthy college-aged males. Appl Physiol Nutr Metab. 2018 Jul;43(7):711-717. doi: 10.1139/apnm-2017-0724. Epub 2018 Feb 16.
- Background: PubMed 28750585O'Malley T, Myette-Cote E, Durrer C, Little JP. Nutritional ketone salts increase fat oxidation but impair high-intensity exercise performance in healthy adult males. Appl Physiol Nutr Metab. 2017 Oct;42(10):1031-1035. doi: 10.1139/apnm-2016-0641. Epub 2017 Jul 27.
- Results publication: PubMed 25275931Volek JS, Noakes T, Phinney SD. Rethinking fat as a fuel for endurance exercise. Eur J Sport Sci. 2015;15(1):13-20. doi: 10.1080/17461391.2014.959564. Epub 2014 Oct 2.
- Individual participant dataSharing planned: No
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Post-exercise Period, Ketosis
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 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 10 km time trial, 30s Wingate and Ketone in people with Ketosis 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 3 inclusion and 6 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 23 Jul 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 Sydney EL Isbell, BSc (5196612111, sisbell@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10 km Time trial (time frame: 15-20 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?
On the ClinicalTrials.gov record for NCT03954665, which also lists 3 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 23 Jul 2019.