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

University of British Columbia

Status: Active, not recruiting

Conditions: Hyperglycemia; Ketosis; Diabetes Mellitus, Type 2

Treatments: Other: Inert placebo; Dietary Supplement: Dietary Supplement: D-β-hydroxybutyric acid with R-1,3-butanediol

Study type: Interventional

Funder types: Other

Identifiers

NCT05983562

RKT2D_concentrate

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 30 to 69 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Experimental: Exogenous Ketone Supplement

Experimental group

Description:

Participants will be instructed to consume a total of 177 mL of the exogenous ketone supplement drink (for a total of 30 g of beta-hydroxybutyrate) per day (3 doses at 59 mL containing 10 g of beta-hydroxybutyrate each) for a period of 90 days.

Treatment:

Dietary Supplement: Dietary Supplement: D-β-hydroxybutyric acid with R-1,3-butanediol

Placebo Comparator: Inert placebo

Placebo Comparator group

Description:

Participants will be instructed to consume an equivalent volume (177 mL) of taste- and volume-matched placebo per day (3 doses at 59 mL) for 90 days.

Treatment:

Other: Inert placebo