Exogenous Ketones and Glucose Tolerance

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

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-26

Study Completion Date

2018-10-15

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 an oral glucose tolerance test in individuals with impaired fasting glucose.

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Detailed Description

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Conditions

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Ketones Dietary Supplements

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 oral glucose 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 oral glucose tolerance test.

Interventions

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Ketone monoester

Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior a 2-hour oral glucose tolerance test.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Acute ingestion of a taste-matched placebo prior a 2-hour oral glucose tolerance test.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Not taking any medications affecting glucose metabolism.
* Elevated fasting glucose level (5.6-6.9 mmol/L) OR body mass index \>28 kg/m2 OR elevated waist circumference (\>102 cm for males, \>88 cm for females)

Exclusion Criteria

* Diagnosed with diabetes.
* Diagnosed with heart disease.
* Competitive endurance athlete (self-identified as engaged in specific endurance training in triathlon, cycling, or distance running and competing in races or competition)
* Recent (last 3 months) or current consumption of a low-carbohydrate ketogenic diet
* Current consumption of ketone supplements
* Pregnant or planning to become pregnant during the study (if female)

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No