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

Not Applicable

Not yet recruiting

• Conditions: Ketosis, Metabolic; Immune Functions; Histone Deacetylase (HDAC) Activity
• Interventions: Dietary Supplement: Ketone Monoester (KE)

• Registration Number: NCT06590623
• Lead Sponsor: University of British Columbia

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-05
• Study First Submitted QC: 2024-09-09
• Last Update Submitted: 2024-09-09
• Study First Posted: 2024-09-11
• Last Update Posted: 2024-09-11
• Study Start: 2024-10-01
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Over the age of 19
• Able to fast overnight

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
exogenous ketone supplement	Ketone Monoester (KE)	Participants will consume a ketone monoester supplement (KetoneAid KE4) at a dose of 0.75 g/kg of body weight.

Primary Outcome Measures

Name	Time	Method
β-hydroxybutyrylation of histone in human immune cells using Western blotting	Before (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 Outcome Measures

Name	Time	Method
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.	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.
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.	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 pressure	Before, 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 rate	Before, 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.
Alteration in immune cell functions	Before (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.
Monocytes and lymphocytes Immunophenotyping	Before (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 Disturbance	Before, 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.

Trial Locations

Locations (1)

University of British Columbia Okanagan Campus; 🇨🇦 Kelowna, British Columbia, Canada