Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- change in release of GLP-1
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.
Data on human subjects are sparse and controversial, especially in a long-term manner. We therefore conduct a cross-over study to assess metabolic response to sweetened vs. non-sweetened soft drinks, which are consumed over a period of 4 weeks.
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.
Data on human subjects are sparse and controversial, especially in a long-term manner. We therefore conduct a cross-over study to assess metabolic response to sweetened vs. non-sweetened soft drinks, which are consumed over a period of 4 weeks. Metabolic assessment will be based on oral glucose tolerance tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •no metabolic disorders such as diabetes, hypothyroidism, corticoid therapy, heart or lung disease
研究组 & 干预措施
Non-sweetened soft drink
4-week-intervention with one liter of custom-made soft drink per day; soft drink does not contain glucose or any kind of sweet tasting substance
干预措施: custom-made soft drink (Dietary Supplement)
Sweetened soft drink
4-week-intervention with one liter of custom-made soft drink per day, soft drinks contains an amount of sweetener, which is isosweet compared to 100 g of sucrose in one liter of beverage
干预措施: custom-made soft drink (Dietary Supplement)
结局指标
主要结局
change in release of GLP-1
时间窗: 4 weeks (cross-over)
change in fasting state and post-glucose release of GLP-1 between the two interventions
change in release of insulin
时间窗: 4 weeks (cross-over)
change in fasting state and post-glucose release of insulin between the two interventions
change in release of PYY
时间窗: 4 weeks (cross-over)
change in fasting state and post-glucose release of PYY between the two interventions
change in release of GIP
时间窗: 4 weeks (cross-over)
change in fasting state and post-glucose release of GIP between the two interventions
change in release of GLP-2
时间窗: 4 weeks (cross-over)
change in fasting state and post-glucose release of GLP-2 between the two interventions
change in combined levels of glucose and insulin, expressed in calculated indices for insulin secretion
时间窗: 4 weeks (cross-over)
change in fasting state and post-glucose insulin secretion between the two interventions
change in combined levels of glucose and insulin, expressed in calculated indices for insulin sensitivity
时间窗: 4 weeks (cross-over)
change in fasting state and post-glucose insulin sensitivity between the two 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