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.

Study Overview

• Status: Completed
• Conditions: Dietary Supplement: Ketone Supplement; Dietary Supplement: Placebo
• Intervention / Treatment: Dietary supplement: Ketone monoester; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1V 1V7
      • University of British Columbia, Okanagan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketone monoester; Acute morning dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.45 ml/kg body weight)	Dietary supplement: Ketone monoester; Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior a 2-hour high carbohydrate mixed meal tolerance test.
Placebo Comparator: Placebo; Acute morning dose of flavour-matched placebo.	Dietary supplement: Placebo; Acute ingestion of a taste-matched placebo prior a 2-hour high carbohydrate mixed meal tolerance test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose area under the curve	Area under the curve for glucose during high carbohydrate mixed meal tolerance test	2-hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin area under the curve	Insulin area under the curve during high carbohydrate mixed meal tolerance test	2-hour
Free fatty acids area under the curve	Non-esterified fatty acids area under the curve during high carbohydrate mixed meal tolerance test	2-hour
Glucose incremental area under the curve	Incremental area under the curve (above baseline) for glucose during high carbohydrate mixed meal tolerance test	2-hour
Insulin incremental area under the curve	Incremental area under the curve (above baseline) for insulin during high carbohydrate mixed meal tolerance test	2-hour
2-hr glucose level	Plasma glucose assessed 2-hr after high carbohydrate mixed meal tolerance test	2-hour
Beta-hydroxybutyrate level	Blood beta-hydroxybutyrate concentration assessed by handheld monitor	2-hour

Collaborators and Investigators

• Sponsor: University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): October 30, 2019
• Study Completion (Actual): January 5, 2020

Study Registration Dates

• First Submitted: September 11, 2019
• First Submitted That Met QC Criteria: September 11, 2019
• First Posted (Actual): September 13, 2019

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: H16-01846-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No