Effect of Protein and Retinol on Alcohol-induced FGF21

NCT ID: NCT06105476

Last Updated: 2024-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-20

Study Completion Date

2024-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aims of this study are two-fold. First to investigate the influence of protein on the FGF21 response induced by alcohol, and second to investigate the influence of retinol on FGF21 concentrations and the FGF21 response induced by alcohol. Exploratory, and in order to investigate mechanisms behind the potential influence on alcohol-induced FGF21 response from protein or retinol intake, plasma glucose, insulin, glucagon, ethanol, acetaldehyde, acetate, retinol, retinoic acid, as well as subjective rating of appetite, will be measured.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Alcohol

Group Type EXPERIMENTAL

Alcohol

Intervention Type OTHER

Test drink with 12 g alcohol (30 g vodka 40%) in water

Alcohol+protein

Group Type EXPERIMENTAL

Alcohol+protein

Intervention Type OTHER

Test drink with 12 g alcohol (30 g vodka 40%) and 25 g whey protein in water

Alcohol+retinol

Group Type EXPERIMENTAL

Alcohol+retinol

Intervention Type OTHER

Test drink with 12 g alcohol (30 g vodka 40%) and 1000 μg retinol in water

Retinol

Group Type EXPERIMENTAL

Retinol

Intervention Type OTHER

Test drink with 1000 μg retinol in water

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Alcohol

Test drink with 12 g alcohol (30 g vodka 40%) in water

Intervention Type OTHER

Alcohol+protein

Test drink with 12 g alcohol (30 g vodka 40%) and 25 g whey protein in water

Intervention Type OTHER

Alcohol+retinol

Test drink with 12 g alcohol (30 g vodka 40%) and 1000 μg retinol in water

Intervention Type OTHER

Retinol

Test drink with 1000 μg retinol in water

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Informed consent
* Healthy men and women
* Age between 18 and 50 years
* Body mass index (BMI) between 20 and 27 kg/m2

Exclusion Criteria

* Chronic diseases or significant health problems that are disruptive for participation in the study (as judged by the principal investigator/clinical responsible)
* Use, currently or within the previous 3 months, of medication that has the potential of affecting any of the blood parameters assessed in the study (as judged by the investigators)
* Blood donation within the last 3 months or during the study period
* Regular smoking or other nicotine use (electronic cigarettes, gum, snus, etc.) or nicotine cessation within the past 3 months.
* Currently dieting or having lost/gained a significant amount of weight (±3 kg) in the previous 3 months
* Women who are pregnant, breast-feeding or have the intention of becoming pregnant during the study period
* Food allergies or food intolerance relevant for the study (judged by the investigators)
* Substance abuse (alcohol and/or drugs) within the last 12 months
* Average weekly alcohol intake above the recommendations from the Danish Health and Medicines Authority (10 standard units per week)
* Taking dietary supplements containing vitamin A during the past 3 months
* Simultaneous participation in other clinical studies that can interfere with the current study
* Inability, physically or mentally, to comply with the procedures required by the study protocol
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Niels Grarup

Role: PRINCIPAL_INVESTIGATOR

Novo Nordisk Foundation Center for Basic Metabolic Research, Health and Medical Sciences, University of Copenhagen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Departmen of Nutrition, Exercise and Sports

Copenhagen, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FGF21-APA

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Alcohol in the Treatment of Obesity
NCT00594074 TERMINATED NA