Fibroblast Growth Factor 21, Tast Perference
Conditions
Brief summary
The primary objective is to evaluate taste preferences for alcohol during an intravenous infusion of the naturally occurring hormone fibroblast growth factor-21 (FGF21) and placebo (i.e. saline), respectively, in 20 healthy subjects. Secondary endpoints are to evaluate the effects of exogenous FGF21 (compared to placebo) on resting energy expenditure, preference for salt, sour and bitter taste qualities, sensations of hunger, thirst, appetite, satiety, headache and nausea, and makers of glucose metabolism (e.g. plasma/serum concentrations of glucose, C-peptide, insulin and glucagon).
Interventions
OTHERFibroblast growth factor 21 infusion
Infusion of Fibroblast growth factor 21
OTHERPlacebo infusion (saline)
Infusion of Saline
Sponsors
The Novo Nordisk Foundation Center for Basic Metabolic Research
University Hospital, Gentofte, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Informed consent * Caucasian male * Body mass index between 19 and 27 kg/m2 * Normal haemoglobin and normal glycated haemoglobin A1c (HbA1c) (\< 42 mmol/mol) * Weekly alcohol intake of less than 14 units of alcohol (1 unit = 12 g ethanol)
Exclusion criteria
* Liver diseases evaluated by plasma alanine aminotransferase (ALAT) \> 3 × normal level or an International Normalized Ratio (INR) below normal values * Diabetes mellitus * Nephropathy * First-degree relatives with diabetes and/or liver diseases and/or alcohol use disorder * Other diseases the investigator finds disruptive for participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol preference (How much do you want to drink alcohol?) | 1 year | Evaluated by Visual analogue scale from not at all to more than ever |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum insulin concentration | 1 year | Serum insulin concentration |
| Plasma fibroblast growth factor-21 concentration | 1 year | Plasma fibroblast growth factor-21 concentration |
| Serum C-peptide concentration | 1 year | Serum C-peptide concentration |
| Plasma glucagon concentration | 1 year | Serum C-peptide concentration |
| Plasma glucose concentration | 1 year | Plasma glucose concentration |
| Plasma insulin-like growth factor 1 concentration | 1 year | Plasma insulin-like growth factor 1 concentration |
| Plasma bone marker concentration | 1 year | Plasma concentrations of the bone markers carboxy-terminal collagen crosslink and procollagen type 1 N-terminal propeptide |
| Resting energy expenditure | 1 year | Evaluated by indirect calorimetry |
| Plasma lipid profile | 1 year | Plasma concentrations of triglycerides, total cholesterol, free fatty acids |
Countries
Denmark
Outcome results
None listed