Ketone Supplementation, Glucose Control, and Cardiovascular Function

University of British Columbia

Status: Completed

Conditions: Overweight and Obesity; Diabetes Mellitus Risk; Hyperglycemia, Postprandial

Treatments: Dietary Supplement: Exogenous ketone monoester

Study type: Interventional

Funder types: Other

Identifiers

NCT03817749

H18-02930

Details and patient eligibility

About

Post-prandial hyperglycemic excursions induce a cascade of deleterious effects on the body, including increased inflammation, production of reactive oxygen species, and impaired cardiovascular function. Ingestion of an exogenous oral ketone supplement blunts hyperglycemia in response to an oral glucose tolerance test. Accordingly, it is hypothesized that exogenous ketone supplement ingestion prior to a meal could be an effective strategy for blunting postprandial hyperglycemia. Therefore, the purpose of this study is to investigate the effect of short-term (14-days) pre-meal exogenous ketone supplementation on glucose control, cardiovascular function, inflammation, and oxidative stress in individuals at an elevated risk of type 2 diabetes.

Enrollment: 15 patients

Sex: All

Ages: 30 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elevated waist circumference (>102 cm for males, >88 cm for females) and/or Obesity (BMI > 30 kg/m2) and/or Diagnoses of prediabetes based on A1C (5.7-6.4%) and/or fasting plasma glucose (5.6-6.9 mmol/l) using ADA criteria

Exclusion criteria

• Competitively trained endurance athlete
• Actively attempting to lose weight
• History of mental illness or existing neurological disease(s)
• Previous cardiovascular events (i.e., heart attack, stroke)
• Diagnoses of diabetes
• Hypoglycemia
• Irritable bowel syndrome or inflammatory bowel disease
• Taking medication that may interfere with insulin sensitivity
• Currently following a ketogenic diet or taking ketone supplements
• Unable to commit for 2 separate 14-day trials and unable to follow a controlled diet

Trial design

Primary purpose: Prevention

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 20 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 6 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: Exogenous ketone monoester