Effect of Protein and Retinol on Alcohol-induced FGF21
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Plasma FGF21 response after consumption of alcohol+protein vs alcohol
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent
- •Healthy men and women
- •Age between 18 and 50 years
- •Body mass index (BMI) between 20 and 27 kg/m2
排除标准
- •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
结局指标
主要结局
Plasma FGF21 response after consumption of alcohol+protein vs alcohol
时间窗: 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
时间窗: Outcomes are measured at time 0, 30, 60, 120, 180, and 240 minutes after test drinks.
Time\*drink interaction and iAUC
次要结局
- 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.)