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

University of Copenhagen

Status: Completed

Conditions: Healthy

Treatments: Other: Alcohol; Other: Alcohol+retinol; Other: Retinol; Other: Alcohol+protein

Study type: Interventional

Funder types: Other

Identifiers

NCT06105476

FGF21-APA

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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31 participants in 4 patient groups

Alcohol

Experimental group

Treatment:

Other: Alcohol

Alcohol+protein

Experimental group

Treatment:

Other: Alcohol+protein

Alcohol+retinol

Experimental group

Treatment:

Other: Alcohol+retinol

Retinol

Experimental group

Treatment:

Other: Retinol