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临床试验/NCT04991714
NCT04991714已完成早期 1 期

Einfluss Der Süßintensität Einer Saccharose-Lösung Auf Die Blutglukoseregulation Und Energieaufnahme in Gesunden Männern

University of Vienna1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年8月5日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Blood glucose concentration

研究概览

简要总结

The aim of the present study is to investigate the influence of the modulation of the sweetness intensity of a carbohydrate (sucrose)-containing solution on metabolic effects, in particular the regulation of blood glucose concentration and regulation of hunger & satiety.

详细描述

The study is designed as a randomised cross-over intervention study with four interventions. The study investigates the influence of sweetness modulation by Rebaudioside M (sweetness enhancement) and Lactisol (sweetness inhibition) of a 10% sucrose solution, corresponding to the concentration of a regular soft drink, on blood glucose regulation (blood glucose concentration and regulating hormones) in healthy male volunteers. Furthermore, the study assesses ad libitum energy intake, individual feelings of hunger and satiety, metabolic responses to the interventions, and preference for sweet-tasting foods such as sugar and sweeteners. In addition, the participants' individual thresholds for sweet taste, as well as morphological markers for taste sensitivity and body composition will be recorded as potential influencing factors.

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 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • non-smoking
  • normal taste responses towards sweet taste

排除标准

  • regular smokers
  • disturbed glucose and/or lipid metabolism
  • regular intake of medication
  • known allergies against one of the test compounds
  • alcohol or drug addiction
  • intake of antibiotics within the past 2 months

研究组 & 干预措施

Sucrose

Experimental

10% solution in water

干预措施: Sucrose (Other)

Sucrose + Reb M

Experimental

10% sucrose + 60 mg/L Rebaudioside M

干预措施: Rebaudioside M (Drug)

Sucrose + Reb M

Experimental

10% sucrose + 60 mg/L Rebaudioside M

干预措施: Sucrose (Other)

Sucrose + Lactisole

Experimental

10% sucrose + 30 mg/ L Lactisole

干预措施: Lactisole (Drug)

Sucrose + Lactisole

Experimental

10% sucrose + 30 mg/ L Lactisole

干预措施: Sucrose (Other)

Sucrose + Reb M + Lactisole

Experimental

10% sucrose + 60 mg/L Rebaudioside M + 30 mg/ L Lactisole

干预措施: Lactisole (Drug)

Sucrose + Reb M + Lactisole

Experimental

10% sucrose + 60 mg/L Rebaudioside M + 30 mg/ L Lactisole

干预措施: Rebaudioside M (Drug)

Sucrose + Reb M + Lactisole

Experimental

10% sucrose + 60 mg/L Rebaudioside M + 30 mg/ L Lactisole

干预措施: Sucrose (Other)

结局指标

主要结局

Blood glucose concentration

时间窗: over a time span of 120 minutes after drinking the test solution

Glucose concentration \[mg/dL\] in plasma samples before, and 15, 30, 60, 90, and 120 minutes after drinking the test solution

GLP-1 concentration

时间窗: over a time span of 120 minutes after drinking the test solution

Glucagon-like peptide 1 concentration in plasma samples \[mmol/L\] before, and 15, 30, 60, 90, and 120 minutes after drinking the test solution

GIP-concentration

时间窗: over a time span of 120 minutes after drinking the test solution

Gastric inhibitory polypeptide concentration in plasma samples \[mmol/L\] before, and 15, 30, 60, 90, and 120 minutes after drinking the test solution

Insulin concentration

时间窗: over a time span of 120 minutes after drinking the test solution

Insulin concentration \[mmol/L\] in plasma samples before, and 15, 30, 60, 90, and 120 minutes after drinking the test solution

次要结局

  • Metabolic changes(over a time span of 120 minutes after drinking the test solution)
  • Food intake(120 minutes after drinking of the test solution)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Barbara Lieder

Deptuy Head Department of Physiological Chemistry

University of Vienna

研究点 (1)

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