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Metabolomic Signature of Exogenous Ketosis (KM)

Primary Purpose

Ketosis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
(R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ketosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of British Columbia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ketone monoester

Arm Description

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.

Outcomes

Primary Outcome Measures

Beta-hydroxybutyrate-derived metabolites
Metabolites derived from the enzymatic conjugation of beta-hydroxybutyrate to amino acids

Secondary Outcome Measures

Full Information

First Posted
December 21, 2022
Last Updated
May 12, 2023
Sponsor
University of British Columbia
Collaborators
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT05699707
Brief Title
Metabolomic Signature of Exogenous Ketosis
Acronym
KM
Official Title
The Effect of Acute Exogenous Oral Ketone Supplementation on the Plasma Metabolomic Signature in Healthy Individuals: An Exploration of Novel Ketone-derived Metabolites
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
April 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ketosis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-arm pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketone monoester
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
(R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester
Intervention Description
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.
Primary Outcome Measure Information:
Title
Beta-hydroxybutyrate-derived metabolites
Description
Metabolites derived from the enzymatic conjugation of beta-hydroxybutyrate to amino acids
Time Frame
90 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of British Columbia
City
Kelowna
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The investigators will share individual patient data (de-identified) with researchers upon request.

Learn more about this trial

Metabolomic Signature of Exogenous Ketosis

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