Diabetes Mellitus, Type 2, Hyperglycemia, Ketosis
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTDietary Supplement: D-β-hydroxybutyric acid with R-1,3-butanediol
Pre-intervention (baseline) and post-intervention measurements will be obtained before and after the 90-day period respectively.
OTHERInert placebo
Pre-intervention (baseline) and post-intervention measurements will be obtained before and after the 90-day period respectively
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 69 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Supplement acceptability | Days 1, 45, and 90 | Supplement acceptability will be assessed via questionnaire. |
| Gastrointestinal distress | Days 1, 45, and 90 | Gastrointestinal distress will be assessed via questionnaire. |
| 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 waist circumference | ay 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). |
| Self-reported energy consumption | Days 0 (pre-intervention/baseline), 45, and 90 | Self-reported energy consumption will be assessed via 24-hour dietary recalls. |
| Levels of perceived hunger | Days 0 (pre-intervention/baseline), 45, and 90 | Levels of perceived hunger 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. |
| 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 (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. |
| 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) and 45 | Theory of planned behaviour will be assessed via questionnaire. |
| 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. |
| 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). |
| Theory of planned behaviour | Days 0 (pre-intervention/baseline) and 45 | Theory of planned behaviour will be assessed via questionnaire. |
| Overall acceptability | Day 90 or in case of withdrawal | Will be assessed via an open ended questionnaire either at completion time or in case of withdrawal |
| 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. |
| 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 (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. |
Countries
Canada
Outcome results
None listed