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

NCT ID: NCT05477368

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-28
• Study Completion Date: 2023-08-31

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.

Conditions

Diabetes; Hyperglycemia; Ketosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Exogenous Ketone 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.

Group Type: EXPERIMENTAL

D-β-hydroxybutyric acid with R-1,3-butanediol

Intervention Type: DIETARY_SUPPLEMENT

Pre-intervention (baseline) and post-intervention measurements will be obtained before and after the 90-day period respectively.

Inert placebo

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.

Group Type: PLACEBO_COMPARATOR

Inert placebo

Intervention Type: OTHER

Pre-intervention (baseline) and post-intervention measurements will be obtained before and after the 90-day period respectively.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Inert placebo

Pre-intervention (baseline) and post-intervention measurements will be obtained before and after the 90-day period respectively.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Little

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan Little, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

University of British Columbia

Kelowna, British Columbia, Canada

Countries

Canada

Other Identifiers

H22-00644

Identifier Type: -

Identifier Source: org_study_id