Metabolomic Signature of Exogenous Ketosis

Ketosis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05699707
• Other study ID #: KM2022
• Status: Completed
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: April 1, 2023

Study information

• Verified date: May 2023
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ketosis

Intervention

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.

Locations

Country	Name	City	State
Canada	University of British Columbia	Kelowna

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Stanford University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beta-hydroxybutyrate-derived metabolites	Metabolites derived from the enzymatic conjugation of beta-hydroxybutyrate to amino acids	90 minutes