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The study aims to investigate changes in blood glucose metabolism after administration of a ketone ester drink.
New-onset prediabetes is the most significant risk factor for diabetes. Clinical studies in healthy human volunteers have demonstrated that ketone esters lower blood glucose levels in both fasting and fed state.
Participants will visit the COSMOS clinic on two occasions and will be randomly allocated to receive either the HVMN ketone drink or placebo, in a cross-over design. Blood samples will be collected sequentially every 30 minutes for up to 150 minutes. Blood samples will be assayed for glucose and other markers of glucose metabolism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HVMN ketone drink | Active Comparator | HVMN ketone drink will be given in a total volume of 100 ml. |
|
| Placebo | Placebo Comparator | Placebo will be given in a total volume of 100 ml. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HVMN Ketone | Other | Water-based, flavoured sport beverage |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of change in plasma glucose concentration | Changes in plasma glucose concentration before and after administration of the intervention/placebo | Baseline, 30, 60, 90, 120, and 150 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of change in plasma insulin and C-peptide concentrations | Changes in plasma insulin and C-peptide concentrations before and after administration of the intervention/placebo | Baseline, 30, 60, 90, 120, and 150 minutes |
| Rate of change in plasma concentration of gut and pancreatic hormones |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Auckland; Auckland City Hospital | Auckland | New Zealand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41725999 | Derived | Liu Y, Kimita W, Bharmal SH, Petrov MS. Changes in apolipoproteins following ingestion of a beverage delivering beta-hydroxybutyrate: results from a randomized placebo-controlled trial. Front Nutr. 2026 Feb 5;12:1726174. doi: 10.3389/fnut.2025.1726174. eCollection 2025. | |
| 38927068 | Derived | Charles S, Liu Y, Bharmal SH, Kimita W, Petrov MS. Effect of Acute Nutritional Ketosis on Circulating Levels of Growth Differentiation Factor 15: Findings from a Cross-Over Randomised Controlled Trial. Biomolecules. 2024 Jun 6;14(6):665. doi: 10.3390/biom14060665. |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D007662 | Ketosis |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo |
| Other |
Water, stevia, malic acid, and thickening agent |
|
Changes in plasma concentrations of ghrelin, incretins, cholecystokinin, gastrin-releasing peptide, peptide YY, oxyntomodulin, motilin, glucagon, amylin, pancreatic polypeptide, and vasoactive intestinal peptide before and after administration of the intervention/placebo |
| Baseline, 30, 60, 90, 120, and 150 minutes |
| Rate of change in lipid profile and digestive enzymes | Changes in plasma concentration of triglycerides, glycerol, cholesterol, lipases before and after administration of the intervention/placebo | Baseline, 30, 60, 90, 120, and 150 minutes |
| Rate of change in plasma concentration of pro-inflammatory cytokines | Changes in plasma concentration of interleukin-1β, interleukin-6, leptin, tumor necrosis factor α, and monocyte chemoattractant protein-1 and other cytokines before and after administration of the intervention/placebo | Baseline, 30, 60, 90, 120, and 150 minutes |
| Rate of change in plasma concentration of markers of iron metabolism | Changes in plasma concentration of ferritin, hepcidin, transferrin receptor before and after administration of the intervention/placebo | Baseline, 30, 60, 90, 120, and 150 minutes |
| Correlation with body fat phenotypes | Differences in the association between rate of change in plasma glucose concentration and magnetic resonance imaging-derived visceral fat volume in the intervention/placebo | 150 minutes |
| Correlation with body fat phenotypes | Differences in the association between rate of change in plasma glucose concentration and magnetic resonance imaging-derived subcutaneous fat volume in the intervention/placebo | 150 minutes |
| Correlation with body fat phenotypes | Differences in the association between rate of change in plasma glucose concentration and magnetic resonance imaging-derived liver fat per centage in the intervention/placebo | 150 minutes |
| Correlation with physical activity | Differences in the association between rate of change in plasma glucose concentration and metabolic equivalents score in the intervention/placebo | 150 minutes |
| 36594212 | Derived | Charles S, Liu Y, Kimita W, Ko J, Bharmal SH, Petrov MS. Effect of D-beta-hydroxybutyrate-(R)-1,3 butanediol on plasma levels of asprosin and leptin: results from a randomised controlled trial. Food Funct. 2023 Jan 23;14(2):759-768. doi: 10.1039/d2fo02405e. |
| 36565045 | Derived | Liu Y, Bharmal SH, Kimita W, Petrov MS. Effect of d-beta-Hydroxybutyrate-(R)-1,3 Butanediol on Appetite Regulation in People with Prediabetes. Mol Nutr Food Res. 2023 Feb;67(4):e2200615. doi: 10.1002/mnfr.202200615. Epub 2023 Jan 26. |
| 35871064 | Derived | Liu Y, Bharmal SH, Kimita W, Petrov MS. Effect of acute ketosis on lipid profile in prediabetes: findings from a cross-over randomized controlled trial. Cardiovasc Diabetol. 2022 Jul 23;21(1):138. doi: 10.1186/s12933-022-01571-z. |
| 34024503 | Derived | Bharmal SH, Alarcon Ramos GC, Ko J, Petrov MS. Abdominal fat distribution modulates the metabolic effects of exogenous ketones in individuals with new-onset prediabetes after acute pancreatitis: Results from a randomized placebo-controlled trial. Clin Nutr ESPEN. 2021 Jun;43:117-129. doi: 10.1016/j.clnesp.2021.03.013. Epub 2021 Mar 21. |
| 33561274 | Derived | Bharmal SH, Cho J, Alarcon Ramos GC, Ko J, Cameron-Smith D, Petrov MS. Acute Nutritional Ketosis and Its Implications for Plasma Glucose and Glucoregulatory Peptides in Adults with Prediabetes: A Crossover Placebo-Controlled Randomized Trial. J Nutr. 2021 Apr 8;151(4):921-929. doi: 10.1093/jn/nxaa417. |
| D004700 | Endocrine System Diseases |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |