Metabolomic Signature of Exogenous Ketosis

Study Overview
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Brief Summary
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Ketone bodies are a fuel source and signaling molecule that are produced by your body during prolonged fasting or if you consistently eat at low-carbohydrate diet. Blood ketones can be used as a source of energy during fasting and are used by your brain as an alternative source of fuel to glucose. Previous studies have found that ketones, when consumed in form of a supplement drink, can increase blood ketone levels and lower blood glucose, the amount of sugar in your blood. This is of potential interest for individuals with high blood sugar, such as people living with type 2 diabetes. However, how ketone supplements impact metabolism is not fully understood but using high throughput analysis techniques that can characterize hundreds to thousands of metabolites in the blood (known as metabolomics) may allow researchers to discover novel compounds within the body that are altered by ketone supplements. This will improve our understanding of how ketones impact metabolism and guide future research.

Official Title
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The Effect of Acute Exogenous Oral Ketone Supplementation on the Plasma Metabolomic Signature in Healthy Individuals: An Exploration of Novel Ketone-derived Metabolites

Conditions
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Ketosis

Intervention / Treatment
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* Dietary Supplement: (R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over the age of 18 years able to fast overnight Exclusion Criteria: being a competitive endurance athlete following a ketogenic diet, low-calorie diet, periodic fasting regimen, or regular consuming ketone supplements being unable to travel to and from the university being pregnant or planning to become pregnant during the study having been diagnosed with a chronic disorder of glucose or fat metabolism, including type 2 diabetes, chronic pancreatitis, or gallbladder disease being unable to read or communicate in English

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Interventional Model Description: Single-arm pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketone monoester<br>0.75 g/kg body mass of ketone monoester to be consumed within 5 minutes with venous blood samples obtained pre-ingestion, and 30-, 60- and 90-minutes post-ingestion. | Dietary Supplement: (R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester<br>* Participants will consume a ketone monoester drink (0.75 k/kg body mass) with venous blood samples obtained before and after (30, 60 and 90 minutes) drink consumption.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beta-hydroxybutyrate-derived metabolites | Metabolites derived from the enzymatic conjugation of beta-hydroxybutyrate to amino acids | 90 minutes |