Dietary Supplement: Ketone SupplementPhase 1NCT04088617
The Effects of Exogenous Ketones on Glucose Tolerance
A Phase 1 study testing Ketone monoester in people with Dietary Supplement: Ketone Supplement and Dietary Supplement: Placebo, run by University of British Columbia at 1 site in Canada.
Trial summary
The ketone body beta-hydroxybutyrate is produced during prolonged fasting or when endogenous carbohydrate stores are depleted and can be used as an alternative fuel source. Exogenous beta-hydroxybutyrate, in the form of a ketone monoester, is proposed to have glucose-lowering potential but this has not been adequately… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Supplement: Ketone Supplement, Dietary Supplement: Placebo
- What is being tested?
- Ketone monoester
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2019to 5 Jan 2020
- Phase
- Phase 1
- 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
- Young healthy individuals
- Not taking any medications affecting glucose metabolism
Who cannot join
- Competitive endurance athlete (i.e., train specifically for cycling, triathlon or distance running and compete at a high level)
- Diagnosed with the chronic medical condition that may impact consumption of carbohydrates or supplements (e.g., diabetes, heart disease)
- Are currently using medications that may interfere with insulin sensitivity
- Adhere to a strict high-fat low-carbohydrate or ketogenic diet (within the last 3 months)
- Are currently using ketone supplements
- Unable to travel to and from the university in order to make your testing appointments.
- Unable to follow the controlled diet instructions required for the study.
- If pregnant or are planning to become pregnant during the study (if female)
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia, Okanagan
Kelowna, British Columbia, V1V 1V7
About this study
The ketone body beta-hydroxybutyrate is produced during prolonged fasting or when endogenous carbohydrate stores are depleted and can be used as an alternative fuel source. Exogenous beta-hydroxybutyrate, in the form of a ketone monoester, is proposed to have glucose-lowering potential but this has not been adequately studied. The purpose of this study is to determine whether supplementing with an acute dose of ketone monoester can improve the glycemic response to a high carbohydrate mixed meal in young healthy individuals.
- Being tested
- Ketone monoester, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone monoesterDietary supplement
Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior a 2-hour high carbohydrate mixed meal tolerance test.
PlaceboDietary supplement
Acute ingestion of a taste-matched placebo prior a 2-hour high carbohydrate mixed meal tolerance test.
| Study group | Role | What they receive |
|---|---|---|
| Ketone monoester | Experimental | Acute morning dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.45 ml/kg body weight) Receives: Dietary Supplement: Ketone monoester |
| Placebo | Placebo comparator | Acute morning dose of flavour-matched placebo. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose area under the curve
Area under the curve for glucose during high carbohydrate mixed meal tolerance test
Measured: 2-hour
Secondary outcomes (6)
Insulin area under the curve
Insulin area under the curve during high carbohydrate mixed meal tolerance test
Measured: 2-hour
Free fatty acids area under the curve
Non-esterified fatty acids area under the curve during high carbohydrate mixed meal tolerance test
Measured: 2-hour
Glucose incremental area under the curve
Incremental area under the curve (above baseline) for glucose during high carbohydrate mixed meal tolerance test
Measured: 2-hour
Insulin incremental area under the curve
Incremental area under the curve (above baseline) for insulin during high carbohydrate mixed meal tolerance test
Measured: 2-hour
2-hr glucose level
Plasma glucose assessed 2-hr after high carbohydrate mixed meal tolerance test
Measured: 2-hour
Beta-hydroxybutyrate level
Blood beta-hydroxybutyrate concentration assessed by handheld monitor
Measured: 2-hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start1 Aug 2019
- Primary completion30 Oct 2019
- Study completion5 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary Supplement: Ketone SupplementStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Little, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088617
- Sponsor's protocol ID
- H16-01846-B
- Status last verified
- Mar 2020
- First submitted
- 11 Sep 2019
- Last updated
- 24 Mar 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 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exogenous Ketones on Glucose Tolerance
- ClinicalTrials.gov ID
- NCT04088617
- Acronym / sponsor ID
- H16-01846-B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 5 Jan 2020 (actual)
- First posted
- 13 Sep 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 ketone body beta-hydroxybutyrate is produced during prolonged fasting or when endogenous carbohydrate stores are depleted and can be used as an alternative fuel source. Exogenous beta-hydroxybutyrate, in the form of a ketone monoester, is proposed to have glucose-lowering potential but this has not been adequately studied. The purpose of this study is to determine whether supplementing with an acute dose of ketone monoester can improve the glycemic response to a high carbohydrate mixed meal in young healthy individuals.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Crossover assignment
| Arm | Type | Receives |
|---|---|---|
| Ketone monoester | Experimental | Dietary Supplement: Ketone monoesterAcute morning dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.45 ml/kg body weight) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboAcute morning dose of flavour-matched placebo. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Young healthy individuals
- Not taking any medications affecting glucose metabolism
Key exclusion criteria (8 listed)
- Competitive endurance athlete (i.e., train specifically for cycling, triathlon or distance running and compete at a high level)
- Diagnosed with the chronic medical condition that may impact consumption of carbohydrates or supplements (e.g., diabetes, heart disease)
- Are currently using medications that may interfere with insulin sensitivity
- Adhere to a strict high-fat low-carbohydrate or ketogenic diet (within the last 3 months)
- Are currently using ketone supplements
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 |
|---|---|---|
| Ketone monoesterAcute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior a 2-hour high carbohydrate mixed meal tolerance test. | Dietary supplement | Ketone monoester |
| PlaceboAcute ingestion of a taste-matched placebo prior a 2-hour high carbohydrate mixed meal tolerance test. | Dietary supplement | Placebo |
Primary outcome
Glucose area under the curve
Time frame: 2-hour
Area under the curve for glucose during high carbohydrate mixed meal tolerance test
6 secondary outcomes
Insulin area under the curve
Time frame: 2-hour
Free fatty acids area under the curve
Time frame: 2-hour
Glucose incremental area under the curve
Time frame: 2-hour
Insulin incremental area under the curve
Time frame: 2-hour
2-hr glucose level
Time frame: 2-hour
Beta-hydroxybutyrate level
Time frame: 2-hour
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 24 Mar 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ketone monoester in people with Dietary Supplement: Ketone Supplement and Dietary Supplement: Placebo, run by University of British Columbia 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 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: finished, as of the sponsor's last update on 24 Mar 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. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Glucose area under the curve (time frame: 2-hour). 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 24 Mar 2020.