Ketone Supplementation, Glucose Control, and Cardiovascular Function

University of British Columbia15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Hyperglycemia, Postprandial Overweight and Obesity Diabetes Mellitus Risk

Exogenous ketone monoesterDIETARY_SUPPLEMENT

Participants will consume 20g of the oral ketone monoester supplement 15 minutes prior to each meal of the day for 14 days. All meals will be provided throughout the 14-day supplementation period.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 69 Years

Medical Language ↔ Plain English

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

Locations (1)

University of British Columbia, Okanagan.

Kelowna, British Columbia, Canada

Outcomes

Primary Outcomes

Glucose control

Post-prandial glucose excursions will be measured by continuous glucose monitoring using the iPro2 CGM by Medtronic in both the active and placebo supplement conditions. Post-prandial glucose following breakfast, lunch, and dinner will be averaged together.

Time frame: 2 hours after a meal

Secondary Outcomes

Change from baseline flow mediated dilation at 14 days

Vascular function will be assessed by flow mediated dilation of the brachial artery using vascular ultrasound. A cuff will affixed on the forearm, distal to the brachial artery and will be inflated for 5 minutes. Flow mediation dilation will be measured over a 3-minute period following cuff release.