The Effect of Macronutrients on Fibroblast Growth Factor 21 (FGF21) Secretion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Difference in FGF21 concentration after consumption of sucrose vs. sucrose+protein
研究概览
简要总结
The aim of this randomized cross-over study is to investigate how consumption of protein and fat affects the FGF21 response triggered by sucrose. The hypothesis is that the consumption of protein, but not fat, will attenuate the FGF21 response triggered by sucrose.
Exploratory, and in order to investigate mechanisms behind the potential attenuation in the sucrose-induced FGF21 response after protein consumption, glucose, insulin, glucagon, triglycerides, amino acids, glicentin and cholecystokinin (CCK) will be assessed before and after consumption of sucrose, sucrose+protein and sucrose+fat. Furthermore, the association between the FGF21 response after consumption of sucrose, sucrose + protein and sucrose + fat and subjective rating of appetite for sweet will also be investigated.
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
- Double (Participant, 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
- •Caucasian
- •Healthy men and women
- •Age between 18-50 years
- •Body mass index (BMI) between 20-27 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 principal investigator/clinical responsible)
- •Blood donation within the last 3 months or during the study period
- •Smoking, smoking cessation within the past 3 months, or nicotine use (electronic cigarettes, gum, etc.)
- •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
- •Substance abuse (within the last 12 months)
- •Alcohol intake above the recommendations from the Danish Health and Medicines Authority
- •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
Difference in FGF21 concentration after consumption of sucrose vs. sucrose+protein
时间窗: Difference in plasma concentration of FGF21 between two test days
Difference (pg/ml) in plasma FGF21 concentration after consumption of sucrose vs. sucrose+protein. Concentration of FGF21 is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.
次要结局
- Difference in appetite for sweet after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.(Difference in appetite for sweet between the three test days)
- Difference in FGF21 concentration after consumption of sucrose vs. sucrose+fat(Difference in plasma concentration of FGF21 between two test days)
- Difference in triglyceride concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.(Difference in serum concentration of triglycerides between the three test days)
- Difference in amino acid concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.(Difference in serum concentration of amino acids between the three test days)
- Difference in CCK concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.(Difference in plasma CCK between the three test days)
- Difference in glucose concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.(Difference in plasma concentration of glucose between the three test days)
- Difference in insulin concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.(Difference in serum concentration of insulin between the three test days)
- Difference in glucagon concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.(Difference in plasma concentration of glucagon between the three test days)
- Difference in glicentin concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.(Difference in plasma glicentin between the three test days)