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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
20
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.
University of British Columbia
Kelowna, British Columbia, Canada
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
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