Metabolomic Signature of Exogenous Ketosis

NCT ID: NCT05699707

Last Updated: 2023-05-16

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

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2023-04-01

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.

Detailed Description

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Conditions

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Ketosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single-arm pilot study
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Ketone monoester

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.

Group Type EXPERIMENTAL

(R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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(R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester

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.

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Jonathan Little

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of British Columbia

Kelowna, , Canada

Site Status

Countries

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Canada

Other Identifiers

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KM2022

Identifier Type: -

Identifier Source: org_study_id

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