KetosisNCT05273411
The Effect of Different Ketone Supplements on β-OHB and Blood Glucose in Healthy Individuals
A study testing (R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester, Beta-hydroxybutyric acid and 1,3-Butanediol in people with Ketosis and Blood Glucose, run by University of British Columbia at 1 site in Canada.
Trial summary
Ketone bodies are a fuel source and signaling molecule that are produced by your body during prolonged fasting or if you consistently eat at low-carbohydrate diet. Blood ketones can be used as a source of energy during fasting and are used by your brain as an alternative source of fuel to glucose. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ketosis, Blood Glucose
- What is being tested?
- (R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester, Beta-hydroxybutyric acid and 1,3-Butanediol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 24 Mar 2022to 18 May 2022
- Phase
- Interventional
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over the age of 18;
- able to fast overnight
Who cannot join
- being a competitive endurance athlete;
- following a ketogenic diet, low-calorie diet, periodic fasting regimen, or regularly consuming ketogenic supplements;
- being unable to travel to and from the university;
- being unable to follow the diet instructions;
- being pregnant or planning to become pregnant during the study;
- having been diagnosed with a chronic disorder of glucose or fat metabolism, including type 2 diabetes, chronic pancreatitis, or gallbladder disease;
- being unable to read or communicate in English
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 Different Ketone Supplements on Blood Beta-hydroxybutyrate (β-OHB) and Blood Glucose in Healthy Individuals
Ketone bodies are a fuel source and signaling molecule that are produced by your body during prolonged fasting or if you consistently eat at low-carbohydrate diet. Blood ketones can be used as a source of energy during fasting and are used by your brain as an alternative source of fuel to glucose. Previous studies have found that ketones, when consumed in form of a supplement drink, can increase blood ketone levels and lower blood glucose, the amount of sugar in your blood. This is of potential interest for individuals with high blood sugar, such as people living with type 2 diabetes. However, there are different types of ketone supplements that differ in how they are metabolized in the body. Little is known about how these supplements affect blood ketone and blood glucose levels. The main objective of this study is to determine the effect of three different ketone supplements on blood ketones and blood glucose. The results of this pilot study will be used to guide future research for larger and more extensive studies on ketone supplements.
- Conditions
- Ketosis, Blood Glucose
- Being tested
- (R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester, Beta-hydroxybutyric acid, 1,3-Butanediol
- Medical subject headings
- Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoesterDietary supplement
Also called Exogenous Ketones
Single-dose pharmacokinetic study over 4 hours.
Beta-hydroxybutyric acidDietary supplement
Also called Exogenous Ketones
Beta-hydroxybutyric acid
1,3-ButanediolDietary supplement
Also called Exogenous Ketones
1,3-Butanediol
| Study group | Role | What they receive |
|---|---|---|
| (R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester | Active comparator | 1 x 20 mL Receives: Dietary Supplement: (R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester |
| Beta-hydroxybutyric acid | Experimental | 1 x 237 mL Receives: Dietary Supplement: Beta-hydroxybutyric acid |
| 1,3-Butanediol | Experimental | 1 x 35 mL Receives: Dietary Supplement: 1,3-Butanediol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Beta-hydroxybutyrate
Are under the curve (AUC) across 240 minutes after supplement consumption (assessed at baseline and 15, 30, 60, 90, 120, 180, and 240 post-supplementation)
Measured: 240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation)
Secondary outcomes (6)
Blood Glucose
Area under the curve (AUC)
Measured: 240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation)
Blood Pressure
Change over time
Measured: 240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation)
Heart Rate
Change over time
Measured: 240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation)
Supplement Acceptability & Taste
Questionnaire
Measured: 240 minutes post-supplementation
Hunger & Fullness
Questionnaire
Measured: 240 minutes post-supplementation
Gastrointestinal Discomfort
Questionnaire
Measured: 60 minutes post-supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start24 Mar 2022
- Primary completion18 May 2022
- Study completion18 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for KetosisStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 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
- NCT05273411
- Sponsor's protocol ID
- H22-00083
- Status last verified
- Feb 2024
- First submitted
- 1 Mar 2022
- Last updated
- 1 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators will share individual patient data (de-identified) with researchers upon request.