The Effects of Exogenous Ketones on Glucose Tolerance

NCT ID: NCT04088617

Last Updated: 2020-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2020-01-05

Brief Summary

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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.

Detailed Description

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Conditions

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Dietary Supplement: Ketone Supplement Dietary Supplement: Placebo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Crossover assignment
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Placebo masked with flavouring and participants consume in opaque containers

Study Groups

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Ketone monoester

Acute morning dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.45 ml/kg body weight)

Group Type EXPERIMENTAL

Ketone monoester

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Acute morning dose of flavour-matched placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Ketone monoester

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Jonathan Little

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of British Columbia, Okanagan

Kelowna, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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H16-01846-B

Identifier Type: -

Identifier Source: org_study_id

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