Examining the Feasibility of Prolonged Ketone Supplement Drink Consumption in Adults With Type 2 Diabetes

Examining the Feasibility of Prolonged Ketone Supplement Drink Consumption in Adults With Type 2 Diabetes

Examining the Feasibility of Prolonged Ketone Supplement Drink Consumption in Adults With Type 2 Diabetes

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.

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.

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.

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.

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.

To determine the feasibility of conducting such an RCT: Retention as measured by the number of participants that complete the study

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)

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)

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)

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)

Self-reported blood pressure (systolic and diastolic) will be assessed via questionnaire (via study-provided blood pressure monitors).

To evaluate the acceptability of the intervention and data collection procedures to participants, assessing the feasibility of implementing the intervention.

To pilot methods for collecting outcome measures and ensure that our plans for recruitment, randomization, treatment, and follow-up are viable

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)

The investigators will share individual patient data (de-identified) with researchers upon reasonable request.

The de-identified data and associated documents will be made available to researchers upon reasonable request for the duration that is required by the researchers.

Researchers from accredited institutions will be granted access to the de-identified data and associated documents provided they can show that it will be used for a research-related purpose (e.g., meta-analysis).