Effect of Protein and Retinol on Alcohol-induced FGF21

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Protein and Retinol on Alcohol-induced FGF21

Conditions
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Healthy

Intervention / Treatment
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* Other: Alcohol
* Other: Alcohol+protein
* Other: Alcohol+retinol
* Other: Retinol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 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*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*drink interaction and iAUC | Outcomes are measured at time 0, 30, 60, 120, 180, and 240 minutes after test drinks. |