Examining the Effect of Exogenous Ketone Supplementation on Glucose Control in Type 2 Diabetes

University of British Columbia

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Exogenous Ketone Monoester

Study type: Interventional

Funder types: Other

Identifiers

NCT05155410

H21-01762

Details and patient eligibility

About

Ketone bodies are a fuel source and signaling molecule that are produced by the body during prolonged fasting or if an individuals consistently eats 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 the functioning of different cells in the body. Recently, the availability of ketone supplements that can be taken orally allows for raising blood ketones without having to fast or eat a "keto" diet. The investigators' studies and those of other researchers have shown that ketone supplementation can lower blood sugar without having to make any other dietary changes. Oral ingestion of ketones may therefore be an effective strategy to improve blood sugar control and influence how cells function.

The main objective of this study is to determine if consuming a ketone supplement 3 times per day (before meals) for 14 days lowers blood sugar and impacts how the body's cells function. The results of this study will be used to guide future recommendations on the utility of ketone supplements for improving health in individuals with, or at elevated risk of, type 2 diabetes.

Enrollment: 15 patients

Sex: All

Ages: 30 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a type 2 diabetes diagnosis from a physician
• Have stable use of glucose-lowering medications for at least 3 months

Exclusion criteria

• Are a competitively trained endurance athlete
• Are actively attempting to gain or lose weight
• Have a history of mental illness or existing neurological disease(s), cardiovascular events (i.e., heart attack, stroke) in the last 2 years
• Have hypoglycemia, irritable bowel syndrome or inflammatory bowel disease
• Are currently using insulin or SGLT2 inhibitors
• Are using more than 2 classes of glucose-lowering medication
• Are currently following a ketogenic diet or taking ketone supplements
• Are unable to commit for a 29-day trial
• Are unable to follow a controlled diet

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

15 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Description:

Participants will consume 15 g of an active oral exogenous ketone monoester supplement 15 minutes prior to each meal of the day for a 14-day period. Pre-intervention (baseline) and post-intervention measurements will be obtained before and immediately after the 14-day period. All meals will be provided throughout the supplementation period Participants will wear a continuous glucose monitor for the first 10 consecutive days during the supplementation period.

Treatment:

Dietary Supplement: Exogenous Ketone Monoester

Placebo

Placebo Comparator group

Description:

Participants will consume a flavor-matched placebo drink and undergo the same procedures described in the Experimental Arm

Treatment:

Dietary Supplement: Placebo