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临床试验/NCT02459535
NCT02459535已完成不适用

Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 1

German Institute of Human Nutrition2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
change in GLP-1 release

研究概览

简要总结

Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft drinks may play a role in the development of diabetes.

Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and even modulate incretin release.

However, it is unclear, if these findings are valid for all kinds of AS, as they are chemically different. Furthermore, data on human subjects are sparse and controversial.

The investigators will therefore conduct 7 consecutive single oral stimulations with glucose or AS alone or a combination. Three different AS will be tested.

详细描述

Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft drinks may play a role in the development of diabetes.

Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and even modulate incretin release.

However, it is unclear, if these findings are valid for all kinds of AS, as they are chemically different. Up to now, no single study has ever compared metabolic responses to different AS in the same subjects. Furthermore, data on human subjects are sparse and controversial. This is partially explained by different methodical approaches such as intragastral/intraduodenal application of AS, rather than conventional oral consumption.

The investigators will therefore conduct 7 consecutive single oral stimulations with glucose or AS alone or a combination. Three different AS will be tested: saccharin, aspartame and sucralose.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • metabolic disorders such as diabetes, hypothyroidism, corticoid therapy, heart or lung disease

结局指标

主要结局

change in GLP-1 release

时间窗: 120 mins

comparison between all seven interventions

change in PYY release

时间窗: 120 mins

comparison between all seven interventions

change in GIP release

时间窗: 120 mins

comparison between all seven interventions

change in GLP-2 release

时间窗: 120 mins

comparison between all seven interventions

change in insulin release

时间窗: 120 mins

comparison between all seven interventions

change in combined blood levels of glucose and insulin, expressed in calculated indices for insulin secretion

时间窗: 120 mins

comparison between all seven interventions

change in combined blood levels of glucose and insulin, expressed in calculated indices for insulin sensitivity

时间窗: 120 mins

comparison between all seven interventions

次要结局

未报告次要终点

研究者

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

Prof. Dr. med. Andreas F. H. Pfeiffer

Director, Department of Clinical Nutrition

German Institute of Human Nutrition

研究点 (2)

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