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临床试验/NCT05705596
NCT05705596已完成早期 1 期

Einfluss Des süßmodulierenden Polyphenols Hesperetin in Kombination Mit Saccharose Auf Die Blutglukose-Regulierung Und Energieaufnahme in Abhängigkeit Der Süßwahrnehmung

University of Vienna1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2023年1月31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
33
试验地点
1
主要终点
Change in blood glucose concentration

研究概览

简要总结

The aim of this cross-over intervention study is to investigate the influence of the sweet-modulating substance hesperetin in combination with sucrose in comparison to an equally sweet-tasting sucrose-only solution on markers of energy metabolism.

详细描述

The study is designed as a randomised cross-over intervention study with two arms. The aim is to investigate the influence of a 10% sucrose solution, corresponding to the sugar content of a conventional soft drink, compared to an equally sweet-tasting 7% sucrose solution in combination with 50 mg/L of the polyphenol hesperetin, on time-dependent blood glucose fluctuations and ad libitum energy intake in metabolically healthy male volunteers.

To investigate the underlying mechanisms, the individual appetite score, metabolic and hormonal responses to the interventions and circulating extracellular vesicles and their miRNA composition will be measured. In addition, the participants' individual thresholds for sweet taste, preference and consumption for sweet-tasting foods such as sugar and sweeteners, and their 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% (w/v) sucrose in water

干预措施: Sucrose (Other)

Hesperetin

Experimental

7% (w/v) sucrose in water + 50 mg/L Hesperetin

干预措施: Hesperetin (Drug)

结局指标

主要结局

Change in blood glucose concentration

时间窗: 15, 30, 60, 90, and 120 minutes after drinking the test solution

Change compared to baseline in blood glucose concentration \[mg/dL\] in plasma samples after drinking the test solution

Change in appetite score

时间窗: Difference between before and 120 minutes after drinking of the test solution

Change compared to baseline in the subjective rating of the individual feeling of hunger, fullness, as well as appetite for a snack or for something sweet on a digital visual analog scale in comparison to baseline

Change in food intake

时间窗: 120 minutes after drinking of the test solution

Ad libitum food intake from a standardized breakfast

次要结局

  • Change in satiety hormones(15, 30, 60, 90, and 120 minutes after drinking the test solution)
  • Change in circulating miRNA(15, 30, 60, 90, and 120 minutes after drinking the test solution)
  • Change in blood glucose regulating hormones(15, 30, 60, 90, and 120 minutes after drinking the test solution)

研究者

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

Barbara Lieder

Professor and Vice Chair Department of Physiological Chemistry

University of Vienna

研究点 (1)

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