The Effects of Exogenous Ketones on Glucose Tolerance

Study Overview
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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.

Official Title
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The Effects of Exogenous Ketones on Glucose Tolerance

Conditions
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Dietary Supplement: Ketone Supplement, Dietary Supplement: Placebo

Intervention / Treatment
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* Dietary Supplement: Ketone monoester
* Dietary Supplement: Placebo


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Crossover assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |