Examining the Feasibility of Prolonged Ketone Supplement Drink Consumption in Adults With Type 2 Diabetes
- Conditions
- KetosisDiabetesHyperglycemia
- Interventions
- Dietary Supplement: D-β-hydroxybutyric acid with R-1,3-butanediolOther: Inert placebo
- Registration Number
- NCT05477368
- Lead Sponsor
- University of British Columbia
- Brief 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.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exogenous Ketone Supplement D-β-hydroxybutyric acid with R-1,3-butanediol 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. Inert placebo 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.
- Primary Outcome Measures
Name Time Method 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 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 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 Across the 90-day intervention period (days 0 through 90) ≤ 30% of recruited participants dropping out of the study will be acceptable.
- Secondary Outcome Measures
Name Time Method Hematology panel Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up) Hematology panel will be measured in a clinical laboratory.
Measures of glycemic control (average daily glucose) Days -5 through 9 (5 days of baseline and first 9 days of intervention period) and days 77 through 90 (last 2 weeks) Glycemic control will be measured by continuous glucose monitoring using the FreeStyle Libre 2 (Abbott) and quantified by assessing the average daily glucose.
Self-reported body weight Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up) Self-reported body weight will be assessed by questionnaire.
Self-reported energy consumption Days 0 (pre-intervention/baseline), 45, and 90 Self-reported energy consumption will be assessed via 24-hour dietary recalls.
Self-rated health Days 0 (pre-intervention/baseline), 45, and 90 Self-rated health and its impacts on daily life will be assessed via questionnaire.
Self-reported blood pressure (systolic and diastolic) Days 0 (pre-intervention/baseline), 45, and 90 Self-reported blood pressure (systolic and diastolic) will be assessed via questionnaire (via study-provided blood pressure monitors).
Measures of glycemic control (postprandial glucose area under the curve) Days -5 through 9 (5 days of baseline and first 9 days of intervention period) and days 77 through 90 (last 2 weeks) Glycemic control will be measured by continuous glucose monitoring using the FreeStyle Libre 2 (Abbott) and quantified by assessing 2-hour postprandial hyperglycemia.
Measures of glycemic control (glucose variability) Days -5 through 9 (5 days of baseline and first 9 days of intervention period) and days 77 through 90 (last 2 weeks) Glycemic control will be measured by continuous glucose monitoring using the FreeStyle Libre 2 (Abbott) and quantified by assessing glucose variability.
Self-reported waist circumference Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up) Self-reported waist circumference will be assessed by questionnaire (using study-provided measurement tape).
Lipid panel (triglycerides, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, non-high density lipoprotein cholesterol, cholesterol/high-density lipoprotein cholesterol ratio) Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up) Lipid panel will be measured in a clinical laboratory.
Levels of physical activity Days 0 (pre-intervention/baseline), 45, and 90 Levels of physical activity will be assessed via questionnaire.
Measures of glycemic control (HbA1c) Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up) Glycemic control will be measured by assessing HbA1c in a clinical laboratory.
Supplement acceptability Days 1, 45, and 90 Supplement acceptability will be assessed via questionnaire.
Levels of perceived hunger Days 0 (pre-intervention/baseline), 45, and 90 Levels of perceived hunger will be assessed via questionnaire.
Gastrointestinal distress Days 1, 45, and 90 Gastrointestinal distress will be assessed via questionnaire.
Liver enzymes (ALT, AST) Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up) Liver enzymes (ALT, AST) will be measured in a clinical laboratory.
Sleep quality Days 0 (pre-intervention/baseline), 45, and 90 Sleep quality will be assessed via questionnaire.
Cravings Days 0 (pre-intervention/baseline), 45, and 90 Cravings will be assessed via questionnaire.
High-sensitivity c-reactive protein Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up) High-sensitivity c-reactive protein will be measured in a clinical laboratory.
Theory of planned behaviour Days 0 (pre-intervention/baseline) and 45 Theory of planned behaviour will be assessed via questionnaire.
Trial Locations
- Locations (1)
University of British Columbia
🇨🇦Kelowna, British Columbia, Canada