The Physiological Effects of FGF21 on Alcohol Preference and Glucose Metabolism

Study Overview
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Brief Summary
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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).

Official Title
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The Physiological Effects of FGF21 on Alcohol Preference and Glucose Metabolism in Healthy Men

Conditions
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Fibroblast Growth Factor 21, Tast Perference

Intervention / Treatment
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* Other: Fibroblast growth factor 21 infusion
* Other: Placebo infusion (saline)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fibroblast growth factor 21 infusion<br>Fibroblast growth factor 21 infusion | Other: Fibroblast growth factor 21 infusion<br>* Infusion of Fibroblast growth factor 21<br>|
| Placebo Comparator: Placebo infusion (saline)<br>Saline infusion | Other: Placebo infusion (saline)<br>* Infusion of Saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol preference (How much do you want to drink alcohol?) | Evaluated by Visual analogue scale from not at all to more than ever | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma glucose concentration | Plasma glucose concentration | 1 year | 
| Serum insulin concentration | Serum insulin concentration | 1 year | 
| Plasma fibroblast growth factor-21 concentration | Plasma fibroblast growth factor-21 concentration | 1 year | 
| Serum C-peptide concentration | Serum C-peptide concentration | 1 year | 
| Plasma glucagon concentration | Serum C-peptide concentration | 1 year | 
| Plasma lipid profile | Plasma concentrations of triglycerides, total cholesterol, free fatty acids | 1 year | 
| Plasma insulin-like growth factor 1 concentration | Plasma insulin-like growth factor 1 concentration | 1 year | 
| Plasma bone marker concentration | Plasma concentrations of the bone markers carboxy-terminal collagen crosslink and procollagen type 1 N-terminal propeptide | 1 year | 
| Resting energy expenditure | Evaluated by indirect calorimetry | 1 year |