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Completed

NCT Number: NCT06105476

Effect of Protein and Retinol on Alcohol-induced FGF21

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Departmen of Nutrition, Exercise and Sports

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alcohol

Other

Test drink with 12 g alcohol (30 g vodka 40%) in water

Alcohol+protein

Other

Test drink with 12 g alcohol (30 g vodka 40%) and 25 g whey protein in water

Alcohol+retinol

Other

Test drink with 12 g alcohol (30 g vodka 40%) and 1000 μg retinol in water

Retinol

Other

Test drink with 1000 μg retinol in water

Primary outcomes

  1. Plasma FGF21 response after consumption of alcohol+protein vs alcohol

    Time frame: Outcomes are measured at time 0, 30, 60, 120, 180, and 240 minutes after test drinks.

    Time*drink interaction and iAUC

  2. Plasma FGF21 response after consumption of alcohol+retinol vs alcohol vs retinol

    Time frame: Outcomes are measured at time 0, 30, 60, 120, 180, and 240 minutes after test drinks.

    Time*drink interaction and iAUC

Secondary outcomes

  1. Plasma glucose, insulin, glucagon, ethanol, acetaldehyde, acetate, retinol, and retinoic acid after consumption of alcohol+protein vs alcohol+retinol vs alcohol vs retinol.

    Time frame: Outcomes are measured at time 0, 30, 60, 120, 180, and 240 minutes after test drinks.

    Time*drink interaction and iAUC

  2. Subjective appetite ratings after consumption of alcohol+protein vs alcohol+retinol vs alcohol vs retinol.

    Time frame: Outcomes are measured at time 0, 30, 60, 120, 180, and 240 minutes after test drinks.

    Time*drink interaction and iAUC

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Acronym: FGF21-APA

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 27, 2023
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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