DiabetesNCT05477368
Examining the Feasibility of Prolonged Ketone Supplement Drink Consumption in Adults With Type 2 Diabetes
A study testing D-β-hydroxybutyric acid with R-1,3-butanediol in people with Diabetes and Hyperglycemia, run by University of British Columbia at 1 site in Canada.
Trial summary
Ketones are a source of energy and signaling molecule that are produced by the body when not consuming any food or consistently eating a low-carbohydrate "keto" diet. Blood ketones can be used as a source of energy by the body, but they may also act as signals that impact how different cells in the body function. Read more about this study
- Who is it for?
- Ages 30 to 69 years
- Conditions the study is for
- Diabetes, Hyperglycemia, Ketosis
- What is being tested?
- D-β-hydroxybutyric acid with R-1,3-butanediol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 28 Sep 2022to Aug 2023
- 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 30 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with type 2 diabetes by a physician at least 1 year prior
- stable use of glucose-lowering medications for at least three months
- must be able to read and understand English in order to complete the study questionnaires
Who cannot join
- competitively trained endurance athlete
- actively attempting to gain or lose weight
- having a history of mental illness or existing neurological disease
- having a history of cardiovascular events in the last two years, hypoglycemia, irritable bowel syndrome, or inflammatory bowel disease
- are currently taking SGLT2 inhibitors or insulin
- are using more than 2 classes of glucose-lowering medication
Show all 10Show fewer
- currently following a ketogenic diet or regularly taking ketone supplements
- unable to commit to a 90-day trial
- being unable to follow remote guidance by internet or smartphone
- currently taking natural or over-the-counter supplements specifically designed to lower blood glucose (e.g., berberine, bitter melon)
Trial locations and contacts
1 site in 1 country.
About this study
Ketones are a source of energy and signaling molecule that are produced by the body when not consuming any food or consistently eating a low-carbohydrate "keto" diet. Blood ketones can be used as a source of energy by the body, but they may also act as signals that impact how different cells in the body function.
Recently, ketone supplements have been developed that can be consumed as a drink. These supplements can raise blood ketones without having to fast or eat a "keto" diet. Previous studies have shown that these supplement drinks can lower blood sugar without having to make any other dietary changes. Drinking these ketone supplements may therefore be an effective strategy to improve blood sugar control and influence how cells function.
To find out if it is feasible for people with type 2 diabetes to drink these ketones supplements regularly over 90 days, we will compare between two groups in this study: one group that will be asked to drink ketone supplements, and one group that will be asked to drink a placebo supplement.
- Conditions
- Diabetes, Hyperglycemia, Ketosis
- Being tested
- D-β-hydroxybutyric acid with R-1,3-butanediol, Inert placebo
- Medical subject headings
- Diabetes Mellitus, Hyperglycemia, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-β-hydroxybutyric acid with R-1,3-butanediolDietary supplement
Pre-intervention (baseline) and post-intervention measurements will be obtained before and after the 90-day period respectively.
Inert placeboOther
Pre-intervention (baseline) and post-intervention measurements will be obtained before and after the 90-day period respectively.
| Study group | Role | What they receive |
|---|---|---|
| Exogenous Ketone Supplement | Experimental | Participants will be instructed to consume a total of 711 mL of the exogenous ketone supplement drink (for a total of 30 g of beta-hydroxybutyrate) per day (3 doses at 237 mL containing 10 g of beta-hydroxybutyrate each) for a period of 90 days. Receives: Dietary Supplement: D-β-hydroxybutyric acid with R-1,3-butanediol |
| Inert placebo | Placebo comparator | Participants will be instructed to consume an equivalent volume (711 mL) of taste- and volume-matched placebo per day (3 doses at 237 mL) for 90 days. Receives: Other: Inert placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the feasibility of conducting a randomized controlled trial (RCT) on the effects of consumption of a ketone supplement in adults with type 2 diabetes in free-living environment for 90 days: Recruitment rate of participants into the trial
A recruitment rate of at least 4 participants per month (which will ensure the study is fully enrolled within a 1-year timeline) will be acceptable.
Measured: Start of enrolment to completion of enrolment
To determine the feasibility of conducting such an RCT: Compliance as measured by the self-reported volume of ketone supplement drink consumed
≥ 67% of the drinks provided being consumed by participants as determined via self-report (i.e., an average of two out of three drinks per day being consumed) will be acceptable.
Measured: Across the 90-day intervention period (days 0 through 90)
To determine the feasibility of conducting such an RCT: Retention as measured by the number of participants that complete the study
≤ 30% of recruited participants dropping out of the study will be acceptable.
Measured: Across the 90-day intervention period (days 0 through 90)
Secondary outcomes (20)
Measures of glycemic control (HbA1c)
Glycemic control will be measured by assessing HbA1c in a clinical laboratory.
Measured: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
Measures of glycemic control (postprandial glucose area under the curve)
Glycemic control will be measured by continuous glucose monitoring using the FreeStyle Libre 2 (Abbott) and quantified by assessing 2-hour postprandial hyperglycemia.
Measured: Days -5 through 9 (5 days of baseline and first 9 days of intervention period) and days 77 through 90 (last 2 weeks)
Measures of glycemic control (average daily glucose)
Glycemic control will be measured by continuous glucose monitoring using the FreeStyle Libre 2 (Abbott) and quantified by assessing the average daily glucose.
Measured: Days -5 through 9 (5 days of baseline and first 9 days of intervention period) and days 77 through 90 (last 2 weeks)
Measures of glycemic control (glucose variability)
Glycemic control will be measured by continuous glucose monitoring using the FreeStyle Libre 2 (Abbott) and quantified by assessing glucose variability.
Measured: Days -5 through 9 (5 days of baseline and first 9 days of intervention period) and days 77 through 90 (last 2 weeks)
Supplement acceptability
Supplement acceptability will be assessed via questionnaire.
Measured: Days 1, 45, and 90
Gastrointestinal distress
Gastrointestinal distress will be assessed via questionnaire.
Measured: Days 1, 45, and 90
Self-reported body weight
Self-reported body weight will be assessed by questionnaire.
Measured: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
Self-reported waist circumference
Self-reported waist circumference will be assessed by questionnaire (using study-provided measurement tape).
Measured: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
Self-reported energy consumption
Self-reported energy consumption will be assessed via 24-hour dietary recalls.
Measured: Days 0 (pre-intervention/baseline), 45, and 90
Levels of perceived hunger
Levels of perceived hunger will be assessed via questionnaire.
Measured: Days 0 (pre-intervention/baseline), 45, and 90
High-sensitivity c-reactive protein
High-sensitivity c-reactive protein will be measured in a clinical laboratory.
Measured: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
Hematology panel
Hematology panel will be measured in a clinical laboratory.
Measured: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
Liver enzymes (ALT, AST)
Liver enzymes (ALT, AST) will be measured in a clinical laboratory.
Measured: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
Lipid panel (triglycerides, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, non-high density lipoprotein cholesterol, cholesterol/high-density lipoprotein cholesterol ratio)
Lipid panel will be measured in a clinical laboratory.
Measured: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
Levels of physical activity
Levels of physical activity will be assessed via questionnaire.
Measured: Days 0 (pre-intervention/baseline), 45, and 90
Theory of planned behaviour
Theory of planned behaviour will be assessed via questionnaire.
Measured: Days 0 (pre-intervention/baseline) and 45
Sleep quality
Sleep quality will be assessed via questionnaire.
Measured: Days 0 (pre-intervention/baseline), 45, and 90
Cravings
Cravings will be assessed via questionnaire.
Measured: Days 0 (pre-intervention/baseline), 45, and 90
Self-rated health
Self-rated health and its impacts on daily life will be assessed via questionnaire.
Measured: Days 0 (pre-intervention/baseline), 45, and 90
Self-reported blood pressure (systolic and diastolic)
Self-reported blood pressure (systolic and diastolic) will be assessed via questionnaire (via study-provided blood pressure monitors).
Measured: Days 0 (pre-intervention/baseline), 45, and 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start28 Sep 2022
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
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 DiabetesStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, 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
- Investigators
- Jonathan Little, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477368
- Sponsor's protocol ID
- H22-00644
- Status last verified
- Jul 2023
- First submitted
- 26 Jul 2022
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will share individual patient data (de-identified) with researchers upon reasonable request.
Publications
Marcotte-Chenard A, Oliveira B, Tortoriello JP, Crampton K, Bouck T, Madden K, Singer J, Falkenhain K, Little JP. Examining the Feasibility of Prolonged Beta-Hydroxybutyrate-Containing Supplement Drink Consumption in Adults with Type 2 Diabetes: A Randomized Controlled Pilot Trial. J Am Nutr Assoc. 2025 Nov-Dec;44(8):777-788. doi: 10.1080/27697061.2025.2518116. Epub 2025 Jun 17.
PubMed 40525864
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Feasibility of Prolonged Ketone Supplement Drink Consumption in Adults With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05477368
- Acronym / sponsor ID
- H22-00644
- Conditions
- Diabetes, Hyperglycemia, Ketosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 28 Jul 2022 (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.
Ketones are a source of energy and signaling molecule that are produced by the body when not consuming any food or consistently eating a low-carbohydrate "keto" diet. Blood ketones can be used as a source of energy by the body, but they may also act as signals that impact how different cells in the body function.
Recently, ketone supplements have been developed that can be consumed as a drink. These supplements can raise blood ketones without having to fast or eat a "keto" diet. Previous studies have shown that these supplement drinks can lower blood sugar without having to make any other dietary changes. Drinking these ketone supplements may therefore be an effective strategy to improve blood sugar control and influence how cells function.
To find out if it is feasible for people with type 2 diabetes to drink these ketones supplements regularly over 90 days, we will compare between two groups in this study: one group that will be asked to drink ketone supplements, and one group that will be asked to drink a placebo supplement.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exogenous Ketone Supplement | Experimental | Dietary Supplement: D-β-hydroxybutyric acid with R-1,3-butanediolParticipants will be instructed to consume a total of 711 mL of the exogenous ketone supplement drink (for a total of 30 g of beta-hydroxybutyrate) per day (3 doses at 237 mL containing 10 g of beta-hydroxybutyrate each) for a period of 90 days. |
| Inert placebo | Placebo comparator | Other: Inert placeboParticipants will be instructed to consume an equivalent volume (711 mL) of taste- and volume-matched placebo per day (3 doses at 237 mL) for 90 days. |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosed with type 2 diabetes by a physician at least 1 year prior
- stable use of glucose-lowering medications for at least three months
- must be able to read and understand English in order to complete the study questionnaires
Key exclusion criteria (10 listed)
- competitively trained endurance athlete
- actively attempting to gain or lose weight
- having a history of mental illness or existing neurological disease
- having a history of cardiovascular events in the last two years, hypoglycemia, irritable bowel syndrome, or inflammatory bowel disease
- are currently taking SGLT2 inhibitors or insulin
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-β-hydroxybutyric acid with R-1,3-butanediolPre-intervention (baseline) and post-intervention measurements will be obtained before and after the 90-day period respectively. | Dietary supplement | Exogenous Ketone Supplement |
| Inert placeboPre-intervention (baseline) and post-intervention measurements will be obtained before and after the 90-day period respectively. | Other | Inert placebo |
Primary outcome
To determine the feasibility of conducting a randomized controlled trial (RCT) on the effects of consumption of a ketone supplement in adults with type 2 diabetes in free-living environment for 90 days: Recruitment rate of participants into the trial
Time frame: Start of enrolment to completion of enrolment
A recruitment rate of at least 4 participants per month (which will ensure the study is fully enrolled within a 1-year timeline) will be acceptable.
To determine the feasibility of conducting such an RCT: Compliance as measured by the self-reported volume of ketone supplement drink consumed
Time frame: Across the 90-day intervention period (days 0 through 90)
≥ 67% of the drinks provided being consumed by participants as determined via self-report (i.e., an average of two out of three drinks per day being consumed) will be acceptable.
To determine the feasibility of conducting such an RCT: Retention as measured by the number of participants that complete the study
Time frame: Across the 90-day intervention period (days 0 through 90)
≤ 30% of recruited participants dropping out of the study will be acceptable.
20 secondary outcomes
Measures of glycemic control (HbA1c)
Time frame: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
Measures of glycemic control (postprandial glucose area under the curve)
Time frame: Days -5 through 9 (5 days of baseline and first 9 days of intervention period) and days 77 through 90 (last 2 weeks)
Measures of glycemic control (average daily glucose)
Time frame: Days -5 through 9 (5 days of baseline and first 9 days of intervention period) and days 77 through 90 (last 2 weeks)
Measures of glycemic control (glucose variability)
Time frame: Days -5 through 9 (5 days of baseline and first 9 days of intervention period) and days 77 through 90 (last 2 weeks)
Supplement acceptability
Time frame: Days 1, 45, and 90
Gastrointestinal distress
Time frame: Days 1, 45, and 90
Self-reported body weight
Time frame: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
Self-reported waist circumference
Time frame: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
Self-reported energy consumption
Time frame: Days 0 (pre-intervention/baseline), 45, and 90
Levels of perceived hunger
Time frame: Days 0 (pre-intervention/baseline), 45, and 90
High-sensitivity c-reactive protein
Time frame: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
Hematology panel
Time frame: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
Liver enzymes (ALT, AST)
Time frame: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
Lipid panel (triglycerides, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, non-high density lipoprotein cholesterol, cholesterol/high-density lipoprotein cholesterol ratio)
Time frame: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
Levels of physical activity
Time frame: Days 0 (pre-intervention/baseline), 45, and 90
Theory of planned behaviour
Time frame: Days 0 (pre-intervention/baseline) and 45
Sleep quality
Time frame: Days 0 (pre-intervention/baseline), 45, and 90
Cravings
Time frame: Days 0 (pre-intervention/baseline), 45, and 90
Self-rated health
Time frame: Days 0 (pre-intervention/baseline), 45, and 90
Self-reported blood pressure (systolic and diastolic)
Time frame: Days 0 (pre-intervention/baseline), 45, and 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Derived from this study: PubMed 40525864Marcotte-Chenard A, Oliveira B, Tortoriello JP, Crampton K, Bouck T, Madden K, Singer J, Falkenhain K, Little JP. Examining the Feasibility of Prolonged Beta-Hydroxybutyrate-Containing Supplement Drink Consumption in Adults with Type 2 Diabetes: A Randomized Controlled Pilot Trial. J Am Nutr Assoc. 2025 Nov-Dec;44(8):777-788. doi: 10.1080/27697061.2025.2518116. Epub 2025 Jun 17.
- Individual participant dataSharing planned: Yes. The investigators will share individual patient data (de-identified) with researchers upon reasonable request.
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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.
Jonathan Little, PhD principal investigator
University of British Columbia
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-β-hydroxybutyric acid with R-1,3-butanediol in people with Diabetes and Hyperglycemia, 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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 1 Aug 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?
Results are not available in the source record.
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?
To determine the feasibility of conducting a randomized controlled trial (RCT) on the effects of consumption of a ketone supplement in adults with type 2 diabetes in free-living environment for 90 days: Recruitment rate of participants into the trial (time frame: Start of enrolment to completion of enrolment). The study lists 3 primary outcomes in all. 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 NCT05477368, 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 1 Aug 2023.