Completed

NCT Number: NCT04088617

The Effects of Exogenous Ketones on Glucose Tolerance

The ketone body beta-hydroxybutyrate is produced during prolonged fasting or when endogenous carbohydrate stores are depleted and can be used as an alternative fuel source. Exogenous beta-hydroxybutyrate, in the form of a ketone monoester, is proposed to have glucose-lowering potential but this has not been adequately studied. The purpose of this study is to determine whether supplementing with an acute dose of ketone monoester can improve the glycemic response to a high carbohydrate mixed meal in young healthy individuals.

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Key information

Conditions

Dietary Supplement: Ketone Supplement Dietary Supplement: Placebo

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of British Columbia, Okanagan

Kelowna, British Columbia, V1V 1V7, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Young healthy individuals
Not taking any medications affecting glucose metabolism

Exclusion criteria

Competitive endurance athlete (i.e., train specifically for cycling, triathlon or distance running and compete at a high level)
Diagnosed with the chronic medical condition that may impact consumption of carbohydrates or supplements (e.g., diabetes, heart disease)
Are currently using medications that may interfere with insulin sensitivity
Adhere to a strict high-fat low-carbohydrate or ketogenic diet (within the last 3 months)
Are currently using ketone supplements
Unable to travel to and from the university in order to make your testing appointments.
Unable to follow the controlled diet instructions required for the study.
If pregnant or are planning to become pregnant during the study (if female)

Treatment and study plan

Ketone monoester

Dietary Supplement

Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior a 2-hour high carbohydrate mixed meal tolerance test.

Placebo

Dietary Supplement

Acute ingestion of a taste-matched placebo prior a 2-hour high carbohydrate mixed meal tolerance test.

Primary outcomes

Glucose area under the curve

Time frame: 2-hour

Area under the curve for glucose during high carbohydrate mixed meal tolerance test

Secondary outcomes

Insulin area under the curve

Time frame: 2-hour

Insulin area under the curve during high carbohydrate mixed meal tolerance test
Free fatty acids area under the curve

Time frame: 2-hour

Non-esterified fatty acids area under the curve during high carbohydrate mixed meal tolerance test
Glucose incremental area under the curve

Time frame: 2-hour

Incremental area under the curve (above baseline) for glucose during high carbohydrate mixed meal tolerance test
Insulin incremental area under the curve

Time frame: 2-hour

Incremental area under the curve (above baseline) for insulin during high carbohydrate mixed meal tolerance test
2-hr glucose level

Time frame: 2-hour

Plasma glucose assessed 2-hr after high carbohydrate mixed meal tolerance test
Beta-hydroxybutyrate level

Time frame: 2-hour

Blood beta-hydroxybutyrate concentration assessed by handheld monitor

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2020
First posted: Sep 13, 2019
Registry last updated: Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.