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An open-labeled intervention study testing healthy, lean, and male volunteers on two separate occasions:
The primary outcome is differences in insulin concentrations (incremental AUC) 180 minutes after 3-OHB consumed orally vs. intravenously.
Secondary outcomes includes iAUC for other gastrointestinal hormones and substrates (Glucagon, GLP-1, GIP, glucose, and 3-OHB) Gastric emptying will be evaluated using 1500 mg Paracetamol consumption before each intervention day. Urine will be analyzed for ketone concentrations/excretion rates.
An open-labeled intervention study testing healthy, lean, and male volunteers on two separate occasions with at least 48 hours apart.
The primary outcome is differences in insulin concentrations (incremental AUC) 180 minutes after 3-OHB consumed orally vs. intravenously.
Secondary outcomes includes iAUC for other gastrointestinal hormones and substrates (Glucagon, GLP-1, GIP, glucose, and 3-OHB) Gastric emptying will be evaluated using 1500 mg Paracetamol consumption before each intervention day. Urine will be analyzed for ketone concentrations/excretion rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3-OHB orally | Experimental | 36 gram 3-OHB salt consumed orally |
|
| 3-OHB intravenously | Active Comparator | Variable amounts of 3-OHB salt given i order to replicate the same individual plasma concentrations measured during the experimental arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3-OHB salt (NaCl) | Dietary Supplement | 36 gram 3-OHB salt diluted in 500 ml sterile water |
|
| Measure | Description | Time Frame |
|---|---|---|
| plasma insulin | incremental area under the curve (iAUC) for plasma insulin concentrations {pmol/l} | 180 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Glucagon | iAUC and concentrations of (Glucagon {pg/ml} | 180 minutes |
| Gastric emptying | Paracetamol test, 1500 mg following interventions and measuring plasma paracetamol {micromol/l} |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niels Jessen, Professor | Aarhus University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Diabetes and Hormone Diseases (DoH) | Aarhus N | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37844838 | Derived | Pedersen MGB, Lauritzen ES, Svart MV, Stoy J, Sondergaard E, Thomsen HH, Kampmann U, Bjerre M, Jessen N, Moller N, Rittig N. Nutrient sensing: LEAP2 concentration in response to fasting, glucose, lactate, and beta-hydroxybutyrate in healthy young males. Am J Clin Nutr. 2023 Dec;118(6):1091-1098. doi: 10.1016/j.ajcnut.2023.10.007. Epub 2023 Oct 14. | |
| 32717058 |
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| ID | Term |
|---|---|
| D007662 | Ketosis |
| ID | Term |
|---|---|
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 180 minutes |
| Urine 3-OHB | Excretion rates {gram/hour} will be estimated as = urine output {L} x urine 3-OHB concentration {mmol/l} x 0.1041 {g/mmol}/180 minutes | 180 minutes |
| Plasma GLP1 | iAUC and concentrations of GLP-1 {pmol/l}, | 180 minutes |
| Plasma GIP | iAUC and concentrations of GIP {pmol/l}, | 180 minutes |
| Plasma glucose | iAUC and concentrations of glucose {mmol/l}, | 180 minutes |
| Plasma free fatty acids | iAUC and concentrations of free fatty acids {mmol/l}, | 180 minutes |
| Plasma 3-OHB | iAUC and concentrations of 3-OHB {mmol/l}) | 180 minutes |
| Plasma Ghrelin | iAUC and concentrations of Ghrelin {ng/l}) | 180 minutes |
| Plasma PYY | iAUC and concentrations of PYY {pg/ml}) | 180 minutes |
| height | height {meters} | at time 0 minutes |
| weight | weight {kg} | at time 0 minutes |
| BMI | Body mass index = weight/height^2 | time 0 minutes |
| Blood pressure | Arm blood pressure | time 0 minutes and 180 minutes |
| Satiety questionnaire (Blundell et al. 2010) | VAS/NRS-score of hunger, fullness, satiety, desire, and prospective consumption | At 0, 60, 120, and 180 minutes |
| Ad libitum food intake | gram (and kcal) intake of an ad libitum meal (sandwich) | at time = 180 minutes |
| Rittig N, Svart M, Thomsen HH, Vestergaard ET, Rehfeld JF, Hartmann B, Holst JJ, Johannsen M, Moller N, Jessen N. Oral D/L-3-Hydroxybutyrate Stimulates Cholecystokinin and Insulin Secretion and Slows Gastric Emptying in Healthy Males. J Clin Endocrinol Metab. 2020 Oct 1;105(10):dgaa483. doi: 10.1210/clinem/dgaa483. |