Healthy, Incretin Effect, Ketosis
Conditions
Brief summary
An open-labeled intervention study testing healthy, lean, and male volunteers on two separate occasions: 1. blood sampling after consuming 36 gram 3-Hydroxybutyrate (3-OHB) salt. 2. blood sampling while given a variable rate of 3-OHB salt intravenously to replicate the concentrations seen during oral consumption. 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.
Detailed description
An open-labeled intervention study testing healthy, lean, and male volunteers on two separate occasions with at least 48 hours apart. 1. blood sampling after consuming 36 gram 3-Hydroxybutyrate (3-OHB) salt. 2. blood sampling while given a variable rate of 3-OHB salt intravenously to replicate the concentrations seen during oral consumption. 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.
Interventions
DIETARY_SUPPLEMENT3-OHB salt (NaCl)
36 gram 3-OHB salt diluted in 500 ml sterile water
Sponsors
University of Aarhus
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy * 19\<BMI\<30 * written og oral consent * No allergies to paracetamol
Exclusion criteria
* Chronic disease or daily medical treatment * Daily intake of ketones or ketogenic diets * Speaks and understands Danish * Screening blood sample abnormalities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| plasma insulin | 180 minutes | incremental area under the curve (iAUC) for plasma insulin concentrations {pmol/l} |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Ghrelin | 180 minutes | iAUC and concentrations of Ghrelin {ng/l}) |
| Plasma PYY | 180 minutes | iAUC and concentrations of PYY {pg/ml}) |
| height | at time 0 minutes | height {meters} |
| weight | at time 0 minutes | weight {kg} |
| BMI | time 0 minutes | Body mass index = weight/height\^2 |
| Blood pressure | time 0 minutes and 180 minutes | Arm blood pressure |
| Plasma free fatty acids | 180 minutes | iAUC and concentrations of free fatty acids {mmol/l}, |
| Plasma 3-OHB | 180 minutes | iAUC and concentrations of 3-OHB {mmol/l}) |
| Gastric emptying | 180 minutes | Paracetamol test, 1500 mg following interventions and measuring plasma paracetamol {micromol/l} |
| Urine 3-OHB | 180 minutes | 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 |
| Plasma GLP1 | 180 minutes | iAUC and concentrations of GLP-1 {pmol/l}, |
| Plasma GIP | 180 minutes | iAUC and concentrations of GIP {pmol/l}, |
| Plasma glucose | 180 minutes | iAUC and concentrations of glucose {mmol/l}, |
| Satiety questionnaire (Blundell et al. 2010) | At 0, 60, 120, and 180 minutes | VAS/NRS-score of hunger, fullness, satiety, desire, and prospective consumption |
| Ad libitum food intake | at time = 180 minutes | gram (and kcal) intake of an ad libitum meal (sandwich) |
| Plasma Glucagon | 180 minutes | iAUC and concentrations of (Glucagon {pg/ml} |
Countries
Denmark
Outcome results
None listed