Healthy
Conditions
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.
Interventions
OTHERAlcohol
Test drink with 12 g alcohol (30 g vodka 40%) in water
OTHERAlcohol+protein
Test drink with 12 g alcohol (30 g vodka 40%) and 25 g whey protein in water
OTHERAlcohol+retinol
Test drink with 12 g alcohol (30 g vodka 40%) and 1000 μg retinol in water
OTHERRetinol
Test drink with 1000 μg retinol in water
Sponsors
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma FGF21 response after consumption of alcohol+protein vs alcohol | Outcomes are measured at time 0, 30, 60, 120, 180, and 240 minutes after test drinks. | Time\*drink interaction and iAUC |
| Plasma FGF21 response after consumption of alcohol+retinol vs alcohol vs retinol | Outcomes are measured at time 0, 30, 60, 120, 180, and 240 minutes after test drinks. | Time\*drink interaction and iAUC |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma glucose, insulin, glucagon, ethanol, acetaldehyde, acetate, retinol, and retinoic acid after consumption of alcohol+protein vs alcohol+retinol vs alcohol vs retinol. | Outcomes are measured at time 0, 30, 60, 120, 180, and 240 minutes after test drinks. | Time\*drink interaction and iAUC |
| Subjective appetite ratings after consumption of alcohol+protein vs alcohol+retinol vs alcohol vs retinol. | Outcomes are measured at time 0, 30, 60, 120, 180, and 240 minutes after test drinks. | Time\*drink interaction and iAUC |
Countries
Denmark
Outcome results
None listed