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The goal of this single-blind randomized placebo-controlled trial is to test the effects of an oral ketone supplement on appetite, cognition, metabolism, and cardiovascular function in individuals with obesity and insulin resistance.
The main question[s] it aims to answer are:
Participants will be asked to consume a randomly assigned ketone ester supplement or a placebo and testing will be done to see how the supplement affects the following compared to a placebo:
Researchers will compare individuals with obesity and insulin resistance to individuals with normal weight and no insulin resistance to see if the ketone supplement affects groups differently.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketone Ester | Experimental | Oral ketone ester supplement |
|
| Placebo | Placebo Comparator | Taste and viscosity matched placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketone Ester Supplement | Dietary Supplement | Oral ingestion of a ketone supplement combined with a flavoring agent and diluted in water |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Blood pressure responses (systolic and diastolic) to sympathoexcitation | Baseline (pre-ingestion) |
| Blood pressure | Blood pressure responses (systolic and diastolic) to sympathoexcitation | 30 minutes post ingestion |
| Blood pressure | Blood pressure responses (systolic and diastolic) to sympathoexcitation | 45 minutes post ingestion |
| Blood pressure | Blood pressure responses (systolic and diastolic) to sympathoexcitation | 60 minutes post ingestion |
| Blood pressure | Blood pressure responses (systolic and diastolic) to sympathoexcitation | 75 minutes post ingestion |
| Blood pressure | Blood pressure responses (systolic and diastolic) to sympathoexcitation | 90 minutes post ingestion |
| Blood pressure | Blood pressure responses (systolic and diastolic) to sympathoexcitation | 105 minutes post ingestion |
| Heart Rate | Heart rate responses to sympathoexcitation | Baseline (pre-ingestion) |
| Measure | Description | Time Frame |
|---|---|---|
| Prefrontal Cortex Oxygenation | Near-infrared spectroscopy | Baseline, 90 minutes post ingestion |
| Peripheral Blood Flow | Doppler Ultrasound of Femoral Artery |
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Inclusion Criteria:
Control Participant Eligibility:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Austin J Graybeal, PhD | University of Southern Mississippi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern Mississippi - School of Kinesiology and Nutrition | Hattiesburg | Mississippi | 39406 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40745496 | Derived | Stavres J, Aultman RS, Brandner CF, Vallecillo-Bustos A, Compton AT, Swafford SH, Newsome TA, Graybeal AJ. Influence of exogenous ketosis on spontaneous cardiovagal baroreflex gain and blood pressure responses to isometric handgrip in individuals with metabolic syndrome: a placebo-controlled pilot study. Eur J Appl Physiol. 2026 Jan;126(1):549-562. doi: 10.1007/s00421-025-05921-z. Epub 2025 Jul 31. |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Placebo | Other | Oral ingestion of cellulose combined with a flavoring agent and diluted in water |
|
| Heart Rate | Heart rate responses to sympathoexcitation | 30 minutes post ingestion |
| Heart Rate | Heart rate responses to sympathoexcitation | 45 minutes post ingestion |
| Heart Rate | Heart rate responses to sympathoexcitation | 60 minutes post ingestion |
| Heart Rate | Heart rate responses to sympathoexcitation | 75 minutes post ingestion |
| Heart Rate | Heart rate responses to sympathoexcitation | 90 minutes post ingestion |
| Heart Rate | Heart rate responses to sympathoexcitation | 105 minutes post ingestion |
| Heart Rate Variability | Index of cardiac autonomic control | Baseline (pre-ingestion) |
| Heart Rate Variability | Index of cardiac autonomic control | 45 post ingestion |
| Cardiac Baroreflex Sensitivity | Changes in cardiac interval relative to changes in systolic blood pressure | 105 minutes post ingestion |
| Hunger - Visual Digital Analog Scale (0-100) | Changes in subjective rating of hunger | Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion |
| Fullness - Visual Digital Analog Scale (0-100) | Changes in subjective rating of fullness | Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion |
| Desire to eat - Visual Digital Analog Scale (0-100) | Changes in subjective rating of desire to eat | Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion |
| Prospective consumption of food - Visual Digital Analog Scale (0-100) | Changes in subjective rating of prospective consumption of food | Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion |
| Thirst - Visual Digital Analog Scale (0-100) | Changes in subjective rating of thirst | Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion |
| Stroop Test - Digital Cognitive Function Test | Changes in Stroop score | Baseline, 75 minutes |
| Go/No-go Test - Digital Cognitive Function Test | Changes in Go/No-go score | Baseline, 75 minutes |
| Task Switching Task - Digital Cognitive Function Test | Changes in Task Switching Task score | Baseline, 75 minutes |
| Number Back Test - Digital Cognitive Function Test | Changes in Number Back Test score | Baseline, 75 minutes |
| Digit Span Test - Digital Cognitive Function Test | Changes in Digit Span Test score | Baseline, 75 minutes |
| Baseline, 30, 60 and 90 minutes post ingestion |
| Peripheral Vascular Conductance | Blood flow normalized to blood pressure (mL/min/mmHg) | Baseline, 30, 60 and 90 minutes post ingestion |
| Blood ketones | Ketone body level from capillary blood | Baseline, 30, 60, 90, 120 minutes post ingestion |
| Blood glucose | Blood glucose level from capillary blood | Baseline, 30, 60, 90, 120 minutes post ingestion |
| Oxygen Consumption from Respiratory Gases | Amount of oxygen consumed using indirect calorimetry | Baseline and continuous for 120 minutes |
| Carbon Dioxide Produced from Respiratory Gases | Amount of carbon dioxide produced using indirect calorimetry | Baseline and continuous for 120 minutes |
| D009750 |
| Nutritional and Metabolic Diseases |