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Completed

NCT Number: NCT04232033

The Physiological Effects of FGF21 on Alcohol Preference and Glucose Metabolism

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).

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Key information

Conditions

Fibroblast Growth Factor 21 Tast Perference

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Amalie R Lanng

Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fibroblast growth factor 21 infusion

Other

Infusion of Fibroblast growth factor 21

Placebo infusion (saline)

Other

Infusion of Saline

Primary outcomes

  1. Alcohol preference (How much do you want to drink alcohol?)

    Time frame: 1 year

    Evaluated by Visual analogue scale from "not at all" to "more than ever"

Secondary outcomes

  1. Plasma glucose concentration

    Time frame: 1 year

    Plasma glucose concentration

  2. Serum insulin concentration

    Time frame: 1 year

    Serum insulin concentration

  3. Plasma fibroblast growth factor-21 concentration

    Time frame: 1 year

    Plasma fibroblast growth factor-21 concentration

  4. Serum C-peptide concentration

    Time frame: 1 year

    Serum C-peptide concentration

  5. Plasma glucagon concentration

    Time frame: 1 year

    Serum C-peptide concentration

  6. Plasma lipid profile

    Time frame: 1 year

    Plasma concentrations of triglycerides, total cholesterol, free fatty acids

  7. Plasma insulin-like growth factor 1 concentration

    Time frame: 1 year

    Plasma insulin-like growth factor 1 concentration

  8. Plasma bone marker concentration

    Time frame: 1 year

    Plasma concentrations of the bone markers carboxy-terminal collagen crosslink and procollagen type 1 N-terminal propeptide

  9. Resting energy expenditure

    Time frame: 1 year

    Evaluated by indirect calorimetry

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Collaborators

  • The Novo Nordisk Foundation Center for Basic Metabolic Research

Registry information

Official study title

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

Acronym: AlcoPref

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Jan 18, 2020
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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