The Effect of Acute Exogenous Oral Ketone Supplementation on Immune Cells Function and Immune Cells Histone Β-hydroxybutyrylation

NCT06590623 | Recruiting

• 1 other identifier: H24-02548
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

To conduct a single-arm pilot study to determine how acute ingestion of an exogenous ketone monoester supplement alters the histone lysine β-hydroxybutyrylation and immune function in healthy human monocytes and lymphocytes.

Conditions

Ketosis, Metabolic; Immune Functions; Histone Deacetylase (HDAC) Activity

Keywords

Ketone supplement; Exogenous ketones; Immune function; β-hydroxybutyrylation; Beta-Hydroxybutyrate

Outcome Measures

Primary Outcomes (1)

• β-hydroxybutyrylation of histone in human immune cells using Western blotting

  The β-hydroxybutyrylation of histones in human monocytes and lymphocytes will be assessed before and 2 hours after the consumption of an exogenous ketone supplement. Protein samples will be collected from the cells, and the levels of histone β-hydroxybutyrylation will be quantified using Western blotting.

  Before (fasted state) and 2 hours after the consumption of the exogenous ketone supplement.

Secondary Outcomes (7)

• Change in beta-hydroxybutyrate concentration

  Capillary beta-hydroxybutyrate will be measured before, 30, 60, 90, 120 and 180 minutes after the consumption of exogenous ketone supplement.

• Change in glucose concentration

  Capillary glucose concentration will be measured before, 30, 60, 90, 120, and 180 minutes after the consumption of exogenous ketone supplement.

• Change in blood pressure

  Before, 30, 60, 90, 120 and 180 minutes after the consumption of the exogenous ketone supplement.

• Change in resting heart rate

  Before, 30, 60, 90, 120 and 180 minutes after the consumption of the exogenous ketone supplement.

• Alteration in immune cell functions

  Before (fasted state) and 2 hours after the consumption of the exogenous ketone supplement.

Study Arms (1)

exogenous ketone supplement

EXPERIMENTAL

Participants will consume a ketone monoester supplement (KetoneAid KE4) at a dose of 0.75 g/kg of body weight.

Dietary Supplement: Ketone Monoester (KE)

Interventions

Ketone Monoester (KE) DIETARY_SUPPLEMENT

Participants will receive an exogenous ketone supplement (KetoneAid KE4) in a fasted state in the morning, at a dosage of 0.75 g/kg of body weight.

Also known as: Exogenous ketone

exogenous ketone supplement

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over the age of 19
• 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 regularly consuming ketogenic supplements.
• Being unable to travel to and from the university
• Being pregnant.
• 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

Study Sites (1)

University of British Columbia Okanagan Campus

Kelowna, British Columbia, V1V1V7, Canada

RECRUITING

MeSH Terms

Conditions

Ketosis; Motor Activity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jonathan Little Principal Investigator, Professor Little, Ph.D

CONTACT

250-807-9876; jonathan.little@ubc.ca

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

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)