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

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.

Study Overview

• Status: Recruiting
• Conditions: Immune Functions; Histone Deacetylase (HDAC) Activity; Ketosis, Metabolic
• Intervention / Treatment: Dietary supplement: Ketone Monoester (KE)

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonathan Little Principal Investigator, Professor Little, Ph.D; Phone Number: 250-807-9876; Email: jonathan.little@ubc.ca

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1V1V7
      • Recruiting
      • University of British Columbia Okanagan Campus
      • Contact: Alexis Marcotte-Chénard Postdoctoral fellow, Ph.D; Phone Number: 250-807-9876; Email: alexis.marcottechenard@ubc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Over the age of 19
• Able to fast overnight

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: exogenous ketone supplement; 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); 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.; Other Names: Exogenous ketone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in beta-hydroxybutyrate concentration	Capillary beta-hydroxybutyrate concentration will be measured using FreeStyle Neo β ketone test before, 30, 60, 90, 120, and 180 minutes after the consumption of exogenous ketone supplement.	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 using FreeStyle Neo glucose test before, 30, 60, 90, 120, and 180 minutes after the consumption of exogenous ketone supplement.	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	Systolic and diastolic blood pressure will be measured using an automatic blood pressure device before, and at 30, 60, 90, 120, and 180 minutes after consuming the exogenous ketone supplement.	Before, 30, 60, 90, 120 and 180 minutes after the consumption of the exogenous ketone supplement.
Change in resting heart rate	Resting heart rate will be measured using continuous heart rate measurement (POLAR H10) before, and at 30, 60, 90, 120, and 180 minutes after consuming the exogenous ketone supplement.	Before, 30, 60, 90, 120 and 180 minutes after the consumption of the exogenous ketone supplement.
Alteration in immune cell functions	Immune cell functions in healthy individuals will be assessed using whole blood and monocyte cultures treated with lipopolysaccharide (with or without interleukin-10) and the subsequent measurement of cytokine secretion (e.g., TNF-a), both before and 2 hours after the ingestion of a ketone supplement.	Before (fasted state) and 2 hours after the consumption of the exogenous ketone supplement.
Monocytes and lymphocytes Immunophenotyping	Immunophenotyping of monocytes and lymphocytes will be conducted by assessing surface receptor expression using flow cytometry. Various antibodies will be used, including CD14, CD16, and TLR4 for monocytes, and CD4 and CD8 for lymphocytes, at baseline and 2 hours following the ingestion of a ketone supplement.	Before (fasted state) and 2 hours after the consumption of the exogenous ketone supplement.
Gastrointestinal Disturbance	Gastrointestinal disturbance will be measured using a 10-cm visual analogue scale to assess nausea, urge to vomit, bloating, belching, and cramps before, and at 30, 60, 90, 120, and 180 minutes after consuming the exogenous ketone supplement. A higher score, closer to the right end of the 10-cm visual analogue scale, indicates greater gastrointestinal disturbance.	Before, and at 30, 60, 90, 120, and 180 minutes after consuming the exogenous ketone supplement.

Collaborators and Investigators

• Sponsor: University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: September 5, 2024
• First Submitted That Met QC Criteria: September 9, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Immune function; Exogenous ketones; Ketone supplement; β-hydroxybutyrylation; Beta-Hydroxybutyrate
• Additional Relevant MeSH Terms: Metabolic Diseases; Acid-Base Imbalance; Acidosis; Ketosis
• Other Study ID Numbers: H24-02548

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared to ensure the privacy and confidentiality of participants, in accordance with ethical guidelines and data protection regulations. Additionally, this was not included in the informed consent, which did not cover data sharing or address potential risks of re-identification.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No