Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 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
- 是
入选标准
- 未提供
排除标准
- •metabolic disorders such as diabetes, hypothyroidism, corticoid therapy, heart or lung disease
研究组 & 干预措施
Glucose only
oral ingestion of 54 g Glucose in 300 ml water at t=0 in fasted state; blood samples over 120 mins
干预措施: oral stimulation glucose (Other)
Glucose + Saccharin
oral ingestion of 54 g Glucose + 0,112 g Saccharin in 300 ml water at t=0 in fasted state; blood samples over 120 mins
干预措施: oral stimulation glucose (Other)
Glucose + Saccharin
oral ingestion of 54 g Glucose + 0,112 g Saccharin in 300 ml water at t=0 in fasted state; blood samples over 120 mins
干预措施: oral stimulation saccharin (Other)
Saccharin only
oral ingestion of 0,112 g Saccharin in 300 ml water at t=0 in fasted state; blood samples over 120 mins
干预措施: oral stimulation saccharin (Other)
Glucose + Aspartame
oral ingestion of 54 g Glucose 0,197 g Aspartame in 300 ml water at t=0 in fasted state; blood samples over 120 mins
干预措施: oral stimulation glucose (Other)
Glucose + Aspartame
oral ingestion of 54 g Glucose 0,197 g Aspartame in 300 ml water at t=0 in fasted state; blood samples over 120 mins
干预措施: oral stimulation aspartame (Other)
Aspartame only
oral ingestion of 0,197 g Aspartame in 300 ml water at t=0 in fasted state; blood samples over 120 mins
干预措施: oral stimulation aspartame (Other)
Glucose + Sucralose
oral ingestion of 54 g Glucose + 0,088 g Sucralose in 300 ml water at t=0 in fasted state; blood samples over 120 mins
干预措施: oral stimulation glucose (Other)
Glucose + Sucralose
oral ingestion of 54 g Glucose + 0,088 g Sucralose in 300 ml water at t=0 in fasted state; blood samples over 120 mins
干预措施: oral stimulation sucralose (Other)
Sucralose only
oral ingestion of 0,088 g Sucralose in 300 ml water at t=0 in fasted state; blood samples over 120 mins
干预措施: oral stimulation sucralose (Other)
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
Prof. Dr. med. Andreas F. H. Pfeiffer
Director, Department of Clinical Nutrition
German Institute of Human Nutrition