Metabolomic Signature of Exogenous Ketosis

NCT05699707 | Completed

• 1 other identifier: KM2022
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Ketosis

Outcome Measures

Primary Outcomes (1)

• Beta-hydroxybutyrate-derived metabolites

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

  90 minutes

Study Arms (1)

Ketone monoester

EXPERIMENTAL

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

Interventions

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

Ketone monoester

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• over the age of 18 years
• able to fast overnight

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Stanford University: collaborator

Study Sites (1)

University of British Columbia

Kelowna, Canada

Location

MeSH Terms

Conditions

Ketosis

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single-arm pilot study

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 26, 2023
• Study Start: February 1, 2023
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)