The Physiological Effects of FGF21 on Alcohol Preference and Glucose Metabolism (AlcoPref)

University Hospital, Gentofte, Copenhagen

Status: Completed

Conditions: Tast Perference; Fibroblast Growth Factor 21

Treatments: Other: Fibroblast growth factor 21 infusion; Other: Placebo infusion (saline)

Study type: Interventional

Funder types: Other

Identifiers

NCT04232033

H-19068397

Details and patient eligibility

About

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).

Enrollment: 20 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Fibroblast growth factor 21 infusion

Active Comparator group

Description:

Fibroblast growth factor 21 infusion

Treatment:

Other: Fibroblast growth factor 21 infusion

Placebo infusion (saline)

Placebo Comparator group

Description:

Saline infusion

Treatment:

Other: Placebo infusion (saline)