An interventional study of D-β-hydroxybutyric acid with R-1,3-butanediol and Inert placebo in Diabetes, Hyperglycemia and Ketosis, sponsored by University of British Columbia. Active, not recruiting at 1 site in Canada. Open to participants aged 30 Years to 69 Years. Per ClinicalTrials.gov, last updated 2023-08-01.
Sponsored by University of British Columbia · Not applicable, Interventional, and Other
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 20 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Dietary Supplement: D-β-hydroxybutyric acid with R-1,3-butanediol
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.
Other: Inert placebo
Pre-intervention (baseline) and post-intervention measurements will be obtained before and after the 90-day period respectively.
Pre-intervention (baseline) and post-intervention measurements will be obtained before and after the 90-day period respectively.
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.
Time frame: 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.
Time frame: 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.
Time frame: Across the 90-day intervention period (days 0 through 90)
Measures of glycemic control (HbA1c)
Glycemic control will be measured by assessing HbA1c in a clinical laboratory.
Time frame: 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.
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)
Glycemic control will be measured by continuous glucose monitoring using the FreeStyle Libre 2 (Abbott) and quantified by assessing the 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)
Glycemic control will be measured by continuous glucose monitoring using the FreeStyle Libre 2 (Abbott) and quantified by assessing 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
Supplement acceptability will be assessed via questionnaire.
Time frame: Days 1, 45, and 90
Gastrointestinal distress
Gastrointestinal distress will be assessed via questionnaire.
Time frame: Days 1, 45, and 90
Self-reported body weight
Self-reported body weight will be assessed by questionnaire.
Time frame: 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).
Time frame: 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.
Time frame: Days 0 (pre-intervention/baseline), 45, and 90
Levels of perceived hunger
Levels of perceived hunger will be assessed via questionnaire.
Time frame: 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.
Time frame: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
Hematology panel
Hematology panel will be measured in a clinical laboratory.
Time frame: 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.
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)
Lipid panel will be measured in a clinical laboratory.
Time frame: 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.
Time frame: Days 0 (pre-intervention/baseline), 45, and 90
Theory of planned behaviour
Theory of planned behaviour will be assessed via questionnaire.
Time frame: Days 0 (pre-intervention/baseline) and 45
Sleep quality
Sleep quality will be assessed via questionnaire.
Time frame: Days 0 (pre-intervention/baseline), 45, and 90
Cravings
Cravings will be assessed via questionnaire.
Time frame: 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.
Time frame: 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).
Time frame: Days 0 (pre-intervention/baseline), 45, and 90
Intervention acceptability
To evaluate the acceptability of the intervention and data collection procedures to participants, assessing the feasibility of implementing the intervention.
Time frame: Across the 90-day intervention period (days 0 through 90)
Viability of methods
To pilot methods for collecting outcome measures and ensure that our plans for recruitment, randomization, treatment, and follow-up are viable
Time frame: Across the 90-day intervention period (days 0 through 90)
Plan to share: Yes — The investigators will share individual patient data (de-identified) with researchers upon reasonable request.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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University of British Columbia