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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06590623
Acronym
Acute_Ketone
Enrollment
12
Registered
2024-09-19
Start date
2024-10-01
Completion date
2025-06-01
Last updated
2025-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

DIETARY_SUPPLEMENTKetone 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.

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
β-hydroxybutyrylation of histone in human immune cells using Western blottingBefore (fasted state) and 2 hours after the consumption of the exogenous ketone supplement.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.

Secondary

MeasureTime frameDescription
Change in glucose concentrationCapillary glucose concentration will be measured before, 30, 60, 90, 120, and 180 minutes after the consumption of exogenous ketone supplement.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.
Change in blood pressureBefore, 30, 60, 90, 120 and 180 minutes after the consumption of the exogenous ketone supplement.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.
Change in resting heart rateBefore, 30, 60, 90, 120 and 180 minutes after the consumption of the exogenous ketone supplement.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.
Change in beta-hydroxybutyrate concentrationCapillary beta-hydroxybutyrate will be measured before, 30, 60, 90, 120 and 180 minutes after the consumption of exogenous ketone supplement.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.
Monocytes and lymphocytes ImmunophenotypingBefore (fasted state) and 2 hours after the consumption of the exogenous ketone supplement.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.
Gastrointestinal DisturbanceBefore, and at 30, 60, 90, 120, and 180 minutes after consuming the exogenous ketone supplement.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.
Alteration in immune cell functionsBefore (fasted state) and 2 hours after the consumption of the exogenous ketone supplement.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.

Countries

Canada

Contacts

Primary ContactJonathan Little Principal Investigator, Professor Little, Ph.D
jonathan.little@ubc.ca250-807-9876

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026