An interventional study of Ketone Monoester (KE) in Ketosis, Metabolic, Immune Functions and Histone Deacetylase (HDAC) Activity, sponsored by University of British Columbia. Recruiting at 1 site in Canada. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-07.
Sponsored by University of British Columbia · Not applicable, Interventional, and Basic science
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.
218 studies on the registry are indexed under Ketosis; 50 are open to participants now.
This study's planned enrollment of 12 is below the median of 20 across 190 interventional studies indexed under Ketosis.
Browse Ketosis studies →University of British Columbia is the lead sponsor of 1,339 studies on the registry; 259 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
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.
Also known as: Exogenous ketone
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.
Time frame: Before (fasted state) and 2 hours after the consumption of the exogenous ketone supplement.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Before, and at 30, 60, 90, 120, and 180 minutes after consuming the exogenous ketone supplement.
Plan to share: No — 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.
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Studies of the drug tested here: (R)-3-hydroxybutyl (R)-3-hydroxybutyrate
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