Effect of Protein and Retinol on Alcohol-induced FGF21
FGF21-APA
1 other identifier
interventional
31
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Nov 2023
Shorter than P25 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2023
CompletedFirst Posted
Study publicly available on registry
October 27, 2023
CompletedStudy Start
First participant enrolled
November 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2024
CompletedAugust 27, 2024
August 1, 2024
4 months
October 12, 2023
August 26, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
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.
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.
Study Arms (4)
Alcohol
EXPERIMENTALAlcohol+protein
EXPERIMENTALAlcohol+retinol
EXPERIMENTALRetinol
EXPERIMENTALInterventions
Test drink with 12 g alcohol (30 g vodka 40%) and 25 g whey protein in water
Test drink with 12 g alcohol (30 g vodka 40%) and 1000 μg retinol in water
Eligibility Criteria
You may qualify if:
- Informed consent
- Healthy men and women
- Age between 18 and 50 years
- Body mass index (BMI) between 20 and 27 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Departmen of Nutrition, Exercise and Sports
Copenhagen, Denmark
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Niels Grarup
Novo Nordisk Foundation Center for Basic Metabolic Research, Health and Medical Sciences, University of Copenhagen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2023
First Posted
October 27, 2023
Study Start
November 20, 2023
Primary Completion
March 31, 2024
Study Completion
March 31, 2024
Last Updated
August 27, 2024
Record last verified: 2024-08