Clinical trial NCT06105476: Effect of Protein and Retinol on Alcohol-induced FGF21
Official title: Effect of Protein and Retinol on Alcohol-induced FGF21
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Plasma FGF21 response after consumption of alcohol+protein vs alcohol
timeFrame: Outcomes are measured at time 0, 30, 60, 120, 180, and 240 minutes after test drinks.
measure: Plasma FGF21 response after consumption of alcohol+retinol vs alcohol vs retinol
timeFrame: Outcomes are measured at time 0, 30, 60, 120, 180, and 240 minutes after test drinks.
Secondary outcomes:
measure: Plasma glucose, insulin, glucagon, ethanol, acetaldehyde, acetate, retinol, and retinoic acid after consumption of alcohol+protein vs alcohol+retinol vs alcohol vs retinol.
timeFrame: Outcomes are measured at time 0, 30, 60, 120, 180, and 240 minutes after test drinks.
measure: Subjective appetite ratings after consumption of alcohol+protein vs alcohol+retinol vs alcohol vs retinol.
timeFrame: Outcomes are measured at time 0, 30, 60, 120, 180, and 240 minutes after test drinks.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Departmen of Nutrition, Exercise and Sports
Study officials:
affiliation: Novo Nordisk Foundation Center for Basic Metabolic Research, Health and Medical Sciences, University of Copenhagen
name: Niels Grarup
role: PRINCIPAL_INVESTIGATOR
References: