Metabolomic Signature of Exogenous Ketosis (KM)

May 12, 2023 updated by: Jonathan Little, University of British Columbia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Kelowna, Canada
        • University of British Columbia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Dietary supplement: (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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

April 1, 2023

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

December 21, 2022

First Submitted That Met QC Criteria

January 22, 2023

First Posted (Actual)

January 26, 2023

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 12, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KM2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators will share individual patient data (de-identified) with researchers upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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