KetosisNCT04881526
Ketone Ester Supplementation on Neuro-cardiovascular Responses to Stress in Humans
A study testing D-beta-hydroxybutyrate in people with Ketosis, run by University of Guelph at 1 site in Canada.
Trial summary
Ketone ester supplementation has become increasingly popular as an athletic supplement. However, the metabolic effects of these supplements on exercise performance are controversial. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Ketosis
- What is being tested?
- D-beta-hydroxybutyrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2021to 1 Dec 2022
- 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
- 18 to 40 years of age
- Healthy, free of known cardiovascular, metabolic, or musculoskeletal disease
Who cannot join
- History of smoking (within 3 months), diagnosed cardiovascular or metabolic disease, recent musculoskeletal injury preventing handgrip exercise, prescription of chronic medications other than oral contraceptives.
- Current or recent (within 6 months) use of ketone ester supplementation or participation in a ketogenic diet.
- Inability to abstain from drugs, caffeine, alcohol, or strenuous physical activity prior to the study visit.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Guelph - Human Cardiovascular Physiology Laboratory
Guelph, Ontario, N1G2W1
About this study
Ketone ester supplementation has become increasingly popular as an athletic supplement. However, the metabolic effects of these supplements on exercise performance are controversial. One potential reason for lack of an ergogenic benefit could be the effects of ketone bodies on other bodily systems, such as the sympathetic nervous system. During exercise and stress the body increases the activity of the sympathetic nervous system. This causes blood vessels to constrict (get smaller) and can increase blood pressure. Studies have shown that ketone bodies can suppress the sympathetic nervous system in mice. Additionally, ketone ester supplementation can reduce blood pressure in healthy adults. In humans, direct measures of sympathetic activity are usually made from sympathetic outflow to muscle, also called muscle sympathetic nerve activity (MSNA). Using a ketone ester supplement, the investigators plan to measure blood pressure and sympathetic outflow to muscle at rest and during handgrip exercise and a mathematical task stress test to investigate the effect of ketones on neuro-cardiovascular stress responses.
- Conditions
- Ketosis
- Being tested
- D-beta-hydroxybutyrate, Placebo
- Medical subject headings
- Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-beta-hydroxybutyrateDietary supplement
Drink containing D-beta-hydroxybutyrate administered at a dose of 395 mg/kg.
PlaceboDietary supplement
Isocaloric flavored water with medium-chain triglyceride oil.
| Study group | Role | What they receive |
|---|---|---|
| Ketone ester drink | Active comparator | Not described Receives: Dietary Supplement: D-beta-hydroxybutyrate |
| Placebo drink | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle sympathetic nerve activity
Microneurography of fibular nerve
Measured: Baseline - Immediately before active and control interventions
Muscle sympathetic nerve activity
Microneurography of fibular nerve
Measured: Post-intervention - Immediately following active and control interventions
Blood pressure
Finger plethysmography
Measured: Baseline - Immediately before active and control interventions
Blood pressure
Finger plethysmography
Measured: Post-intervention - Immediately following active and control interventions
Secondary outcomes (2)
Forearm blood flow
Brachial artery Doppler ultrasound
Measured: Baseline - Immediately before active and control interventions
Forearm blood flow
Brachial artery Doppler ultrasound
Measured: Post-intervention - Immediately following active and control interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start1 Jun 2021
- Primary completion1 Oct 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Millar, University of Guelph
- Investigators
- Philip Millar, PhD, Principal investigator, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881526
- Sponsor's protocol ID
- 21-02-019
- Status last verified
- Sep 2023
- First submitted
- 5 May 2021
- Last updated
- 22 Sep 2023
- 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 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketone Ester Supplementation on Neuro-cardiovascular Responses to Stress in Humans
- ClinicalTrials.gov ID
- NCT04881526
- Acronym / sponsor ID
- 21-02-019
- Conditions
- Ketosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 11 May 2021 (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.
Ketone ester supplementation has become increasingly popular as an athletic supplement. However, the metabolic effects of these supplements on exercise performance are controversial. One potential reason for lack of an ergogenic benefit could be the effects of ketone bodies on other bodily systems, such as the sympathetic nervous system. During exercise and stress the body increases the activity of the sympathetic nervous system. This causes blood vessels to constrict (get smaller) and can increase blood pressure. Studies have shown that ketone bodies can suppress the sympathetic nervous system in mice. Additionally, ketone ester supplementation can reduce blood pressure in healthy adults. In humans, direct measures of sympathetic activity are usually made from sympathetic outflow to muscle, also called muscle sympathetic nerve activity (MSNA). Using a ketone ester supplement, the investigators plan to measure blood pressure and sympathetic outflow to muscle at rest and during handgrip exercise and a mathematical task stress test to investigate the effect of ketones on neuro-cardiovascular stress responses.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketone ester drink | Active comparator | Dietary Supplement: D-beta-hydroxybutyrate |
| Placebo drink | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18 to 40 years of age
- Healthy, free of known cardiovascular, metabolic, or musculoskeletal disease
Key exclusion criteria (3 listed)
- History of smoking (within 3 months), diagnosed cardiovascular or metabolic disease, recent musculoskeletal injury preventing handgrip exercise, prescription of chronic medications other than oral contraceptives.
- Current or recent (within 6 months) use of ketone ester supplementation or participation in a ketogenic diet.
- Inability to abstain from drugs, caffeine, alcohol, or strenuous physical activity prior to the study visit.
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 |
|---|---|---|
| D-beta-hydroxybutyrateDrink containing D-beta-hydroxybutyrate administered at a dose of 395 mg/kg. | Dietary supplement | Ketone ester drink |
| PlaceboIsocaloric flavored water with medium-chain triglyceride oil. | Dietary supplement | Placebo drink |
Primary outcome
Muscle sympathetic nerve activity
Time frame: Baseline - Immediately before active and control interventions
Microneurography of fibular nerve
Muscle sympathetic nerve activity
Time frame: Post-intervention - Immediately following active and control interventions
Microneurography of fibular nerve
Blood pressure
Time frame: Baseline - Immediately before active and control interventions
Finger plethysmography
Blood pressure
Time frame: Post-intervention - Immediately following active and control interventions
Finger plethysmography
2 secondary outcomes
Forearm blood flow
Time frame: Baseline - Immediately before active and control interventions
Forearm blood flow
Time frame: Post-intervention - Immediately following active and control interventions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Ketosis
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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.
Philip Millar, PhD principal investigator
University of Guelph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D-beta-hydroxybutyrate in people with Ketosis, run by University of Guelph 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 3 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: finished, as of the sponsor's last update on 22 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle sympathetic nerve activity (time frame: Baseline - Immediately before active and control interventions). The study lists 4 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 22 Sep 2023.