KetonesPhase 1NCT03461068
Exogenous Ketones and Glucose Tolerance
A Phase 1 study testing Ketone monoester in people with Ketones and Dietary Supplements, 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 30 to 65 years
- Conditions the study is for
- Ketones, Dietary Supplements
- What is being tested?
- Ketone monoester
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 26 Mar 2018to 15 Oct 2018
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Not taking any medications affecting glucose metabolism.
- Elevated fasting glucose level (5.6-6.9 mmol/L) OR body mass index >28 kg/m2 OR elevated waist circumference (>102 cm for males, >88 cm for females)
Who cannot join
- Diagnosed with diabetes.
- Diagnosed with heart disease.
- Competitive endurance athlete (self-identified as engaged in specific endurance training in triathlon, cycling, or distance running and competing in races or competition)
- Recent (last 3 months) or current consumption of a low-carbohydrate ketogenic diet
- Current consumption of ketone supplements
- Pregnant or 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
Official title: The Effect of Exogenous Ketone Monoester Supplement on Glycemic Response to an Oral Glucose Tolerance Test
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 an oral glucose tolerance test in individuals with impaired fasting glucose.
- Conditions
- Ketones, Dietary Supplements
- Being tested
- Ketone monoester, Placebo
- Medical subject headings
- Ketosis
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 oral glucose tolerance test.
PlaceboDietary supplement
Acute ingestion of a taste-matched placebo prior a 2-hour oral glucose 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 oral glucose tolerance test
Measured: 2-hour
Secondary outcomes (11)
Insulin area under the curve
Insulin area under the curve during oral glucose tolerance test
Measured: 2-hour
Free fatty acids area under the curve
Non-esterified fatty acids area under the curve during oral glucose tolerance test
Measured: 2-hour
Caspase-1 activation
Caspase-1 activation assessed before and after ketone or placebo ingestion in the morning
Measured: 15 minutes
Inflammatory cytokines
Inflammatory cytokines assessed before and after ketone or placebo ingestion in the morning
Measured: 15 minutes
C-peptide area under the curve
C-peptide area under the curve during oral glucose tolerance test
Measured: 2-hour
GLP-1 area under the curve
GLP-1 area under the curve during oral glucose tolerance test
Measured: 2-hour
Glucagon area under the curve
Glucagon area under the curve during oral glucose tolerance test
Measured: 2-hour
Glucose incremental area under the curve
Incremental area under the curve (above baseline) for glucose during oral glucose tolerance test
Measured: 2-hour
Insulin incremental area under the curve
Incremental area under the curve (above baseline) for insulin during oral glucose tolerance test
Measured: 2-hour
2-hr glucose level
Plasma glucose assessed 2-hr after oral glucose tolerance test.
Measured: 2-hour
Oral glucose sensitivity index
Oral glucose sensitivity index derived from glucose and insulin values throughout the 2-hr oral glucose tolerance test
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 posted9 Mar 2018
- Study start26 Mar 2018
- Primary completion3 Oct 2018
- Study completion15 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KetonesStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 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
- NCT03461068
- Sponsor's protocol ID
- H16-01846
- Status last verified
- Apr 2019
- First submitted
- 4 Mar 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Myette-Cote E, Caldwell HG, Ainslie PN, Clarke K, Little JP. A ketone monoester drink reduces the glycemic response to an oral glucose challenge in individuals with obesity: a randomized trial. Am J Clin Nutr. 2019 Dec 1;110(6):1491-1501. doi: 10.1093/ajcn/nqz232.
PubMed 31599919
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exogenous Ketone Monoester Supplement on Glycemic Response to an Oral Glucose Tolerance Test
- ClinicalTrials.gov ID
- NCT03461068
- Acronym / sponsor ID
- H16-01846
- Conditions
- Ketones, Dietary Supplements
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 3 Oct 2018 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 9 Mar 2018 (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 an oral glucose tolerance test in individuals with impaired fasting glucose.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| 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
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Not taking any medications affecting glucose metabolism.
- Elevated fasting glucose level (5.6-6.9 mmol/L) OR body mass index >28 kg/m2 OR elevated waist circumference (>102 cm for males, >88 cm for females)
Key exclusion criteria (6 listed)
- Diagnosed with diabetes.
- Diagnosed with heart disease.
- Competitive endurance athlete (self-identified as engaged in specific endurance training in triathlon, cycling, or distance running and competing in races or competition)
- Recent (last 3 months) or current consumption of a low-carbohydrate ketogenic diet
- Current consumption of 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 oral glucose tolerance test. | Dietary supplement | Ketone monoester |
| PlaceboAcute ingestion of a taste-matched placebo prior a 2-hour oral glucose tolerance test. | Dietary supplement | Placebo |
Primary outcome
Glucose area under the curve
Time frame: 2-hour
Area under the curve for glucose during oral glucose tolerance test
11 secondary outcomes
Insulin area under the curve
Time frame: 2-hour
Free fatty acids area under the curve
Time frame: 2-hour
Caspase-1 activation
Time frame: 15 minutes
Inflammatory cytokines
Time frame: 15 minutes
C-peptide area under the curve
Time frame: 2-hour
GLP-1 area under the curve
Time frame: 2-hour
Glucagon 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
Oral glucose sensitivity index
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 18 Apr 2019.
- Derived from this study: PubMed 31599919Myette-Cote E, Caldwell HG, Ainslie PN, Clarke K, Little JP. A ketone monoester drink reduces the glycemic response to an oral glucose challenge in individuals with obesity: a randomized trial. Am J Clin Nutr. 2019 Dec 1;110(6):1491-1501. doi: 10.1093/ajcn/nqz232.
- 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 Ketones and Dietary Supplements, 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 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: finished, as of the sponsor's last update on 18 Apr 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.
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?
On the ClinicalTrials.gov record for NCT03461068, which also lists 1 linked publication.
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 18 Apr 2019.