Ketosis, MetabolicAcute_KetoneNCT06590623
The Effect of Acute Exogenous Oral Ketone Supplementation on Immune Cells Function and Immune Cells Histone Β-hydroxybutyrylation
A study testing Ketone Monoester (KE) in people with Ketosis, Metabolic and Immune Functions, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ketosis, Metabolic, Immune Functions, Histone Deacetylase (HDAC) Activity
- What is being tested?
- Ketone Monoester (KE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over the age of 19
- Able to fast overnight
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jonathan Little Principal Investigator, Professor Little, Ph.D contact
Canada1 site, 1 recruiting
- Recruiting
University of British Columbia Okanagan Campus
Kelowna, British Columbia, V1V1V7
Alexis Marcotte-Chénard Postdoctoral fellow, Ph.D, 250-807-9876, alexis.marcottechenard@ubc.ca
About this study
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.
- Being tested
- Ketone Monoester (KE)
- Keywords
- Ketone supplement, Exogenous ketones, Immune function, β-hydroxybutyrylation, Beta-Hydroxybutyrate
- Medical subject headings
- Ketosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone Monoester (KE)Dietary supplement
Also called Exogenous ketone
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.
| Study group | Role | What they receive |
|---|---|---|
| exogenous ketone supplement | Experimental | Participants will consume a ketone monoester supplement (KetoneAid KE4) at a dose of 0.75 g/kg of body weight. Receives: Dietary Supplement: Ketone Monoester (KE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before, and at 30, 60, 90, 120, and 180 minutes after consuming the exogenous ketone supplement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ketosis, MetabolicStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Little, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590623
- Sponsor's protocol ID
- H24-02548
- Acronym
- Acute_Ketone
- Status last verified
- Mar 2025
- First submitted
- 5 Sep 2024
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acute Exogenous Oral Ketone Supplementation on Immune Cells Function and Immune Cells Histone Β-hydroxybutyrylation
- ClinicalTrials.gov ID
- NCT06590623
- Acronym / sponsor ID
- Acute_Ketone / H24-02548
- Keywords
- Ketone supplement, Exogenous ketones, Immune function, β-hydroxybutyrylation, Beta-Hydroxybutyrate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| exogenous ketone supplement | Experimental | Dietary Supplement: Ketone Monoester (KE)Participants will consume a ketone monoester supplement (KetoneAid KE4) at a dose of 0.75 g/kg of body weight. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over the age of 19
- Able to fast overnight
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketone Monoester (KE)Also: Exogenous ketoneParticipants 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. | Dietary supplement | exogenous ketone supplement |
Primary outcome
β-hydroxybutyrylation of histone in human immune cells using Western blotting
Time frame: 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.
7 secondary outcomes
Change in beta-hydroxybutyrate concentration
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
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
Time frame: Before, 30, 60, 90, 120 and 180 minutes after the consumption of the exogenous ketone supplement.
Change in resting heart rate
Time frame: Before, 30, 60, 90, 120 and 180 minutes after the consumption of the exogenous ketone supplement.
Alteration in immune cell functions
Time frame: Before (fasted state) and 2 hours after the consumption of the exogenous ketone supplement.
Monocytes and lymphocytes Immunophenotyping
Time frame: Before (fasted state) and 2 hours after the consumption of the exogenous ketone supplement.
Gastrointestinal Disturbance
Time frame: Before, and at 30, 60, 90, 120, and 180 minutes after consuming the exogenous ketone supplement.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan Little Principal Investigator, Professor Little, Ph.D contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketone Monoester (KE) in people with Ketosis, Metabolic and Immune Functions, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Little Principal Investigator, Professor Little, Ph.D (250-807-9876, jonathan.little@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
β-hydroxybutyrylation of histone in human immune cells using Western blotting (time frame: Before (fasted state) and 2 hours after the consumption of the exogenous ketone supplement.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.