Effect of Protein and Retinol on Alcohol-induced FGF21

Healthy Clinical Trial

— FGF21-APA  

Official title:

Effect of Protein and Retinol on Alcohol-induced FGF21

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06105476
• Other study ID #: FGF21-APA
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: November 2023
• Source: University of Copenhagen
• Contact: Stina Ramne
• Phone: +4535320230
• Email: stina.ramne[@]sund.ku.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Alcohol
Test drink with 12 g alcohol (30 g vodka 40%) in water
• Alcohol+protein
Test drink with 12 g alcohol (30 g vodka 40%) and 25 g whey protein in water
• Alcohol+retinol
Test drink with 12 g alcohol (30 g vodka 40%) and 1000 µg retinol in water
• Retinol
Test drink with 1000 µg retinol in water

Locations

Country	Name	City	State
Denmark	Departmen of Nutrition, Exercise and Sports	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma FGF21 response after consumption of alcohol+protein vs alcohol	Time*drink interaction and iAUC	Outcomes are measured at time 0, 30, 60, 120, 180, and 240 minutes after test drinks.
Primary	Plasma FGF21 response after consumption of alcohol+retinol vs alcohol vs retinol	Time*drink interaction and iAUC	Outcomes are measured at time 0, 30, 60, 120, 180, and 240 minutes after test drinks.
Secondary	Plasma glucose, insulin, glucagon, ethanol, acetaldehyde, acetate, retinol, and retinoic acid after consumption of alcohol+protein vs alcohol+retinol vs alcohol vs retinol.	Time*drink interaction and iAUC	Outcomes are measured at time 0, 30, 60, 120, 180, and 240 minutes after test drinks.
Secondary	Subjective appetite ratings after consumption of alcohol+protein vs alcohol+retinol vs alcohol vs retinol.	Time*drink interaction and iAUC	Outcomes are measured at time 0, 30, 60, 120, 180, and 240 minutes after test drinks.