Effect of Protein and Retinol on Alcohol-induced FGF21 (FGF21-APA)

August 26, 2024 updated by: University of Copenhagen
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Departmen of Nutrition, Exercise and Sports

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alcohol
Other: Alcohol
Test drink with 12 g alcohol (30 g vodka 40%) in water
Experimental: Alcohol+protein
Other: Alcohol+protein
Test drink with 12 g alcohol (30 g vodka 40%) and 25 g whey protein in water
Experimental: Alcohol+retinol
Other: Alcohol+retinol
Test drink with 12 g alcohol (30 g vodka 40%) and 1000 μg retinol in water
Experimental: Retinol
Other: Retinol
Test drink with 1000 μg retinol in water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma FGF21 response after consumption of alcohol+protein vs alcohol
Time Frame: Outcomes are measured at time 0, 30, 60, 120, 180, and 240 minutes after test drinks.
Time*drink interaction and iAUC
Outcomes are measured at time 0, 30, 60, 120, 180, and 240 minutes after test drinks.
Plasma FGF21 response after consumption of alcohol+retinol vs alcohol vs retinol
Time Frame: Outcomes are measured at time 0, 30, 60, 120, 180, and 240 minutes after test drinks.
Time*drink interaction and iAUC
Outcomes are measured at time 0, 30, 60, 120, 180, and 240 minutes after test drinks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma glucose, insulin, glucagon, ethanol, acetaldehyde, acetate, retinol, and retinoic acid after consumption of alcohol+protein vs alcohol+retinol vs alcohol vs retinol.
Time Frame: Outcomes are measured at time 0, 30, 60, 120, 180, and 240 minutes after test drinks.
Time*drink interaction and iAUC
Outcomes are measured at time 0, 30, 60, 120, 180, and 240 minutes after test drinks.
Subjective appetite ratings after consumption of alcohol+protein vs alcohol+retinol vs alcohol vs retinol.
Time Frame: Outcomes are measured at time 0, 30, 60, 120, 180, and 240 minutes after test drinks.
Time*drink interaction and iAUC
Outcomes are measured at time 0, 30, 60, 120, 180, and 240 minutes after test drinks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Investigators

  • Principal Investigator: Niels Grarup, Novo Nordisk Foundation Center for Basic Metabolic Research, Health and Medical Sciences, University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2023

Primary Completion (Actual)

March 31, 2024

Study Completion (Actual)

March 31, 2024

Study Registration Dates

First Submitted

October 12, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 27, 2023

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 26, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FGF21-APA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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