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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| exogenous ketone supplement | Experimental | Participants will consume a ketone monoester supplement (KetoneAid KE4) at a dose of 0.75 g/kg of body weight. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketone Monoester (KE) | Dietary Supplement | 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Little Principal Investigator, Professor Little, Ph.D | Contact | 250-807-9876 | jonathan.little@ubc.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia Okanagan Campus | Recruiting | Kelowna | British Columbia | V1V1V7 | Canada |
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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| 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. |
| ID | Term |
|---|---|
| D007662 | Ketosis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001519 | Behavior |
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