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OpenTrials
Completed

NCT Number: NCT05699707

Metabolomic Signature of Exogenous Ketosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia

Kelowna, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

(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.

Primary outcomes

  1. Beta-hydroxybutyrate-derived metabolites

    Time frame: 90 minutes

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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Stanford University

Registry information

Official study title

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

Acronym: KM

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 26, 2023
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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