KetosisNCT04194450
Exogenous Ketones in Type 2 Diabetes
A study testing Ketone monoester in people with Ketosis and Type 2 Diabetes, run by University of British Columbia at 1 site in Canada.
Trial summary
Exogenous ketone supplements are proposed to have glucose-lowering potential, provide an alternative fuel for the brain and to enhance cognitive function. No studies have tested whether exogenous ketones can lower blood glucose in people with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 20 to 69 years
- Conditions the study is for
- Ketosis, Type 2 Diabetes
- What is being tested?
- Ketone monoester
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2020to 20 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 20 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- physician-diagnosed type 2 diabetes of ≥1 year
- current hemoglobin A1C (HbA1c) of 6.5-8.0%
- treatment with lifestyle or stable (≥3 months) oral glucose-lowering medications
- blood pressure of <160/99 mm Hg assessed according to guidelines
- non-smoking
- no prior history of cardiovascular disease or stroke
- not on hormone replacement therapy, corticosteroids, or anti-inflammatory medications
- 20-75 years old
Who cannot join
- being a competitive endurance athlete
- taking exogenous insulin or sodium glucose transporter 2 (SGLT2) inhibitors
- following a ketogenic diet, low-calorie diet, periodic fasting regimen, or consume ketogenic supplements
- being unable to travel to and from the university
- being unable to follow the controlled diet instructions
- being pregnant or planning to become pregnant during the study (if female)
- disorders of fat metabolism, chronic pancreatitis, had gastric bypass surgery and/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 Acute Exogenous Oral Ketone Supplementation on Blood Glucose Levels in Type 2 Diabetes
Exogenous ketone supplements are proposed to have glucose-lowering potential, provide an alternative fuel for the brain and to enhance cognitive function. No studies have tested whether exogenous ketones can lower blood glucose in people with type 2 diabetes. In addition, the impact of exogenous ketones on brain blood flow, cognitive function or brain-derived neurotrophic factor in humans is unknown. The purpose of this study is to determine if acutely ingesting exogenous ketones, in the form of a ketone monoester drink, can lower glucose and improve measures of brain/cognitive function in humans with type 2 diabetes. Participants will consume a ketone monoester drink or placebo with blood samples, brain blood flow, and cognitive function assessed over 180 minutes. The researchers will also test how the ketone monoester drink impacts appetite and measures of inflammation.
- Conditions
- Ketosis, Type 2 Diabetes
- Being tested
- Ketone monoester, Placebo
- Medical subject headings
- Ketosis, Diabetes Mellitus, Type 2
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 to assessment of outcomes.
PlaceboDietary supplement
Acute ingestion of taste-matched placebo prior to assessment of outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Ketone monoester | Experimental | Acute dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.3 g/kg body weight) Receives: Dietary Supplement: Ketone monoester |
| Placebo | Placebo comparator | Acute 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.
Plasma Glucose
Plasma glucose concentration after ketone or placebo ingestion
Measured: 180 minutes
Secondary outcomes (15)
Plasma Insulin
Insulin across concentration after ketone or placebo ingestion
Measured: 180 minutes
Plasma C-peptide
C-peptide across concentration after ketone or placebo ingestion
Measured: 180 minutes
Plasma Free Fatty Acids
Non-esterified fatty acid concentration after ketone or placebo ingestion
Measured: 180 minutes
Plasma Tumour Necrosis Factor Alpha
Plasma tumour necrosis factor alpha concentration after ketone or placebo ingestion
Measured: 180 minutes
Plasma Tumour Interleukin-1beta
Plasma tumour interleukin-1beta concentration after ketone or placebo ingestion
Measured: 180 minutes
Plasma Tumour Interleukin-6
Plasma tumour interleukin-6 concentration after ketone or placebo ingestion
Measured: 180 minutes
Cerebral Blood Flow
Intracranial blood flow velocity measured by ultrasound
Measured: 180 minutes
Blood Pressure
Blood pressure measured manually and by Finipres
Measured: 180 minutes
Cognitive Function - Digital Symbol Substitution Task
Number of Correct Answers on the Digital Symbol Substitution Task. Measure of cognitive function using Brain Baseline battery on an iPad.
Measured: 180 minutes
Brain-derived Neurotrophic Factor
Brain-derived neurotrophic factor concentrations after ketone or placebo ingestion
Measured: 180 minutes
Number Blood Monocytes (x10^3 Cells/uL)
Total blood monocytes count (x10^3 cells/uL) after ketone or placebo ingestion
Measured: 180 minutes
Self Reported Hunger and Fullness
Self reported hunger and fullness by a 0 to 100 mm Visual Analog Scale (higher scores mean greater hunger or fullness)
Measured: 180 minutes
Gastrointestinal Symptoms
Gastrointestinal symptom questionnaire scores after ketone or placebo ingestion on a 0 to 100 mm Visual Analog Scale (higher scores mean greater symptoms)
Measured: 180 minutes
Total Energy Consumed
Total energy consumed in kilocalories in buffet style meal after ketone or placebo ingestion
Measured: 180 minutes after ketone or placebo ingestion
Monocyte Histone Acetylation
Histone acetylation status of monocytes measured after ketone or placebo ingestion
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start15 Jan 2020
- Primary completion20 May 2022
- Study completion20 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 19 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
- NCT04194450
- Sponsor's protocol ID
- H19-02947
- Status last verified
- May 2025
- First submitted
- 9 Dec 2019
- Last updated
- 30 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baranowski BJ, Oliveira BF, Falkenhain K, Little JP, Mohammad A, Beaudette SM, Finch MS, Caldwell HG, Neudorf H, MacPherson REK, Walsh JJ. Effect of exogenous beta-hydroxybutyrate on BDNF signaling, cognition, and amyloid precursor protein processing in humans with T2D and insulin-resistant rodents. Am J Physiol Cell Physiol. 2025 Feb 1;328(2):C541-C556. doi: 10.1152/ajpcell.00867.2024. Epub 2025 Jan 13.
PubMed 39804761