The Effects of Exogenous Ketones on Glucose Tolerance

Sponsor

University of British Columbia (Other)

Overall Status

Completed

CT.gov ID

NCT04088617

Collaborator

(none)

Enrollment

Location

Arms

5.2

Actual Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Dietary Supplement: Ketone Supplement Dietary Supplement: Placebo	Dietary Supplement: Ketone monoester Dietary Supplement: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Crossover assignmentCrossover assignment

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Placebo masked with flavouring and participants consume in opaque containers

Primary Purpose:

Basic Science

Official Title:

The Effects of Exogenous Ketones on Glucose Tolerance

Actual Study Start Date :

Aug 1, 2019

Actual Primary Completion Date :

Oct 30, 2019

Actual Study Completion Date :

Jan 5, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Glucose area under the curve [2-hour]
Area under the curve for glucose during high carbohydrate mixed meal tolerance test

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of British Columbia, Okanagan	Kelowna	British Columbia	Canada	V1V 1V7

Sponsors and Collaborators

University of British Columbia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jonathan Little, Associate Professor, University of British Columbia

ClinicalTrials.gov Identifier:

NCT04088617

Other Study ID Numbers:

H16-01846-B

First Posted:

Sep 13, 2019

Last Update Posted:

Mar 24, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 24, 2020