- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05477368
Examining the Feasibility of Prolonged Ketone Supplement Drink Consumption in Adults With Type 2 Diabetes
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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British Columbia
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Kelowna, British Columbia, Canada
- University of British Columbia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exogenous Ketone Supplement
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.
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Pre-intervention (baseline) and post-intervention measurements will be obtained before and after the 90-day period respectively.
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Placebo Comparator: Inert placebo
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.
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Pre-intervention (baseline) and post-intervention measurements will be obtained before and after the 90-day period respectively.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Start of enrolment to completion of enrolment
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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)
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≥ 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.
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Across the 90-day intervention period (days 0 through 90)
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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)
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≤ 30% of recruited participants dropping out of the study will be acceptable.
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Across the 90-day intervention period (days 0 through 90)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measures of glycemic control (HbA1c)
Time Frame: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
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Glycemic control will be measured by assessing HbA1c in a clinical laboratory.
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Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
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Supplement acceptability
Time Frame: Days 1, 45, and 90
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Supplement acceptability will be assessed via questionnaire.
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Days 1, 45, and 90
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Gastrointestinal distress
Time Frame: Days 1, 45, and 90
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Gastrointestinal distress will be assessed via questionnaire.
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Days 1, 45, and 90
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Self-reported body weight
Time Frame: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
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Self-reported body weight will be assessed by questionnaire.
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Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
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Self-reported waist circumference
Time Frame: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
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Self-reported waist circumference will be assessed by questionnaire (using study-provided measurement tape).
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Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
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Self-reported energy consumption
Time Frame: Days 0 (pre-intervention/baseline), 45, and 90
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Self-reported energy consumption will be assessed via 24-hour dietary recalls.
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Days 0 (pre-intervention/baseline), 45, and 90
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Levels of perceived hunger
Time Frame: Days 0 (pre-intervention/baseline), 45, and 90
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Levels of perceived hunger will be assessed via questionnaire.
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Days 0 (pre-intervention/baseline), 45, and 90
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High-sensitivity c-reactive protein
Time Frame: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
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High-sensitivity c-reactive protein will be measured in a clinical laboratory.
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Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
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Hematology panel
Time Frame: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
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Hematology panel will be measured in a clinical laboratory.
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Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
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Liver enzymes (ALT, AST)
Time Frame: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
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Liver enzymes (ALT, AST) will be measured in a clinical laboratory.
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Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
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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)
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Lipid panel will be measured in a clinical laboratory.
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Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
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Levels of physical activity
Time Frame: Days 0 (pre-intervention/baseline), 45, and 90
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Levels of physical activity will be assessed via questionnaire.
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Days 0 (pre-intervention/baseline), 45, and 90
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Theory of planned behaviour
Time Frame: Days 0 (pre-intervention/baseline) and 45
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Theory of planned behaviour will be assessed via questionnaire.
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Days 0 (pre-intervention/baseline) and 45
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Sleep quality
Time Frame: Days 0 (pre-intervention/baseline), 45, and 90
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Sleep quality will be assessed via questionnaire.
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Days 0 (pre-intervention/baseline), 45, and 90
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Cravings
Time Frame: Days 0 (pre-intervention/baseline), 45, and 90
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Cravings will be assessed via questionnaire.
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Days 0 (pre-intervention/baseline), 45, and 90
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Self-rated health
Time Frame: Days 0 (pre-intervention/baseline), 45, and 90
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Self-rated health and its impacts on daily life will be assessed via questionnaire.
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Days 0 (pre-intervention/baseline), 45, and 90
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Self-reported blood pressure (systolic and diastolic)
Time Frame: Days 0 (pre-intervention/baseline), 45, and 90
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Self-reported blood pressure (systolic and diastolic) will be assessed via questionnaire (via study-provided blood pressure monitors).
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Days 0 (pre-intervention/baseline), 45, and 90
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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)
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Glycemic control will be measured by continuous glucose monitoring using the FreeStyle Libre 2 (Abbott) and quantified by assessing 2-hour postprandial hyperglycemia.
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Days -5 through 9 (5 days of baseline and first 9 days of intervention period) and days 77 through 90 (last 2 weeks)
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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)
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Glycemic control will be measured by continuous glucose monitoring using the FreeStyle Libre 2 (Abbott) and quantified by assessing the average daily glucose.
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Days -5 through 9 (5 days of baseline and first 9 days of intervention period) and days 77 through 90 (last 2 weeks)
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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)
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Glycemic control will be measured by continuous glucose monitoring using the FreeStyle Libre 2 (Abbott) and quantified by assessing glucose variability.
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Days -5 through 9 (5 days of baseline and first 9 days of intervention period) and days 77 through 90 (last 2 weeks)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intervention acceptability
Time Frame: Across the 90-day intervention period (days 0 through 90)
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To evaluate the acceptability of the intervention and data collection procedures to participants, assessing the feasibility of implementing the intervention.
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Across the 90-day intervention period (days 0 through 90)
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Viability of methods
Time Frame: Across the 90-day intervention period (days 0 through 90)
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To pilot methods for collecting outcome measures and ensure that our plans for recruitment, randomization, treatment, and follow-up are viable
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Across the 90-day intervention period (days 0 through 90)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jonathan Little, PhD, University of British Columbia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H22-00644
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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