Fibroblast Growth Factor 21AlcoPrefNCT04232033
The Physiological Effects of FGF21 on Alcohol Preference and Glucose Metabolism
A study testing Fibroblast growth factor 21 infusion in people with Fibroblast Growth Factor 21 and Tast Perference, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fibroblast Growth Factor 21, Tast Perference
- What is being tested?
- Fibroblast growth factor 21 infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2021to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Physiological Effects of FGF21 on Alcohol Preference and Glucose Metabolism in Healthy Men
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).
- Conditions
- Fibroblast Growth Factor 21, Tast Perference
- Being tested
- Fibroblast growth factor 21 infusion, Placebo infusion (saline)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibroblast growth factor 21 infusionOther
Infusion of Fibroblast growth factor 21
Placebo infusion (saline)Other
Infusion of Saline
| Study group | Role | What they receive |
|---|---|---|
| Fibroblast growth factor 21 infusion | Active comparator | Fibroblast growth factor 21 infusion Receives: Other: Fibroblast growth factor 21 infusion |
| Placebo infusion (saline) | Placebo comparator | Saline infusion Receives: Other: Placebo infusion (saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol preference (How much do you want to drink alcohol?)
Evaluated by Visual analogue scale from "not at all" to "more than ever"
Measured: 1 year
Secondary outcomes (9)
Plasma glucose concentration
Plasma glucose concentration
Measured: 1 year
Serum insulin concentration
Serum insulin concentration
Measured: 1 year
Plasma fibroblast growth factor-21 concentration
Plasma fibroblast growth factor-21 concentration
Measured: 1 year
Serum C-peptide concentration
Serum C-peptide concentration
Measured: 1 year
Plasma glucagon concentration
Serum C-peptide concentration
Measured: 1 year
Plasma lipid profile
Plasma concentrations of triglycerides, total cholesterol, free fatty acids
Measured: 1 year
Plasma insulin-like growth factor 1 concentration
Plasma insulin-like growth factor 1 concentration
Measured: 1 year
Plasma bone marker concentration
Plasma concentrations of the bone markers carboxy-terminal collagen crosslink and procollagen type 1 N-terminal propeptide
Measured: 1 year
Resting energy expenditure
Evaluated by indirect calorimetry
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 May 2021
- Primary completion14 Jun 2022
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibroblast Growth Factor 21Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- The Novo Nordisk Foundation Center for Basic Metabolic Research
- Responsible party
- Principal investigator, Filip Krag Knop, University Hospital, Gentofte, Copenhagen
- Investigators
- Amalie R Lanng, Dr., Principal investigator, Center for Clinical Metabolic Research, Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232033
- Sponsor's protocol ID
- H-19068397
- Acronym
- AlcoPref
- Status last verified
- Dec 2024
- First submitted
- 7 Jan 2020
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Physiological Effects of FGF21 on Alcohol Preference and Glucose Metabolism in Healthy Men
- ClinicalTrials.gov ID
- NCT04232033
- Acronym / sponsor ID
- AlcoPref / H-19068397
- Conditions
- Fibroblast Growth Factor 21, Tast Perference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- The Novo Nordisk Foundation Center for Basic Metabolic Research
- Study start
- 1 May 2021 (actual)
- Primary completion
- 14 Jun 2022 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibroblast growth factor 21 infusion | Active comparator | Other: Fibroblast growth factor 21 infusionFibroblast growth factor 21 infusion |
| Placebo infusion (saline) | Placebo comparator | Other: Placebo infusion (saline)Saline infusion |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibroblast growth factor 21 infusionInfusion of Fibroblast growth factor 21 | Other | Fibroblast growth factor 21 infusion |
| Placebo infusion (saline)Infusion of Saline | Other | Placebo infusion (saline) |
Primary outcome
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"
9 secondary outcomes
Plasma glucose concentration
Time frame: 1 year
Serum insulin concentration
Time frame: 1 year
Plasma fibroblast growth factor-21 concentration
Time frame: 1 year
Serum C-peptide concentration
Time frame: 1 year
Plasma glucagon concentration
Time frame: 1 year
Plasma lipid profile
Time frame: 1 year
Plasma insulin-like growth factor 1 concentration
Time frame: 1 year
Plasma bone marker concentration
Time frame: 1 year
Resting energy expenditure
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No. Individual participant data will not be available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amalie R Lanng, Dr. principal investigator
Center for Clinical Metabolic Research, Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fibroblast growth factor 21 infusion in people with Fibroblast Growth Factor 21 and Tast Perference, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol preference (How much do you want to drink alcohol?) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.