Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Intervention acceptability |
To evaluate the acceptability of the intervention and data collection procedures to participants, assessing the feasibility of implementing the intervention. |
Across the 90-day intervention period (days 0 through 90) |
|
Other |
Viability of methods |
To pilot methods for collecting outcome measures and ensure that our plans for recruitment, randomization, treatment, and follow-up are viable |
Across the 90-day intervention period (days 0 through 90) |
|
Primary |
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. |
Start of enrolment to completion of enrolment |
|
Primary |
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. |
Across the 90-day intervention period (days 0 through 90) |
|
Primary |
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. |
Across the 90-day intervention period (days 0 through 90) |
|
Secondary |
Measures of glycemic control (HbA1c) |
Glycemic control will be measured by assessing HbA1c in a clinical laboratory. |
Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up) |
|
Secondary |
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. |
Days -5 through 9 (5 days of baseline and first 9 days of intervention period) and days 77 through 90 (last 2 weeks) |
|
Secondary |
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. |
Days -5 through 9 (5 days of baseline and first 9 days of intervention period) and days 77 through 90 (last 2 weeks) |
|
Secondary |
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. |
Days -5 through 9 (5 days of baseline and first 9 days of intervention period) and days 77 through 90 (last 2 weeks) |
|
Secondary |
Supplement acceptability |
Supplement acceptability will be assessed via questionnaire. |
Days 1, 45, and 90 |
|
Secondary |
Gastrointestinal distress |
Gastrointestinal distress will be assessed via questionnaire. |
Days 1, 45, and 90 |
|
Secondary |
Self-reported body weight |
Self-reported body weight will be assessed by questionnaire. |
Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up) |
|
Secondary |
Self-reported waist circumference |
Self-reported waist circumference will be assessed by questionnaire (using study-provided measurement tape). |
Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up) |
|
Secondary |
Self-reported energy consumption |
Self-reported energy consumption will be assessed via 24-hour dietary recalls. |
Days 0 (pre-intervention/baseline), 45, and 90 |
|
Secondary |
Levels of perceived hunger |
Levels of perceived hunger will be assessed via questionnaire. |
Days 0 (pre-intervention/baseline), 45, and 90 |
|
Secondary |
High-sensitivity c-reactive protein |
High-sensitivity c-reactive protein will be measured in a clinical laboratory. |
Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up) |
|
Secondary |
Hematology panel |
Hematology panel will be measured in a clinical laboratory. |
Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up) |
|
Secondary |
Liver enzymes (ALT, AST) |
Liver enzymes (ALT, AST) will be measured in a clinical laboratory. |
Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up) |
|
Secondary |
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. |
Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up) |
|
Secondary |
Levels of physical activity |
Levels of physical activity will be assessed via questionnaire. |
Days 0 (pre-intervention/baseline), 45, and 90 |
|
Secondary |
Theory of planned behaviour |
Theory of planned behaviour will be assessed via questionnaire. |
Days 0 (pre-intervention/baseline) and 45 |
|
Secondary |
Sleep quality |
Sleep quality will be assessed via questionnaire. |
Days 0 (pre-intervention/baseline), 45, and 90 |
|
Secondary |
Cravings |
Cravings will be assessed via questionnaire. |
Days 0 (pre-intervention/baseline), 45, and 90 |
|
Secondary |
Self-rated health |
Self-rated health and its impacts on daily life will be assessed via questionnaire. |
Days 0 (pre-intervention/baseline), 45, and 90 |
|
Secondary |
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). |
Days 0 (pre-intervention/baseline), 45, and 90 |
|