NCT02891525已完成不适用
The Effect of Caloric and Non-caloric Sweeteners on Hunger, Gastrointestinal Hormones as Well as on Antral and Duodenal Motility
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Change in gastrointestinal motility measured by antroduodenal high-resolution manometry
研究概览
简要总结
In this study, the investigators aimed at evaluating the role of sweet taste receptors in the gastrointestinal tract (GIT). Intragastric administration of glucose, fructose or acesulfame-K were compared with placebo administration for their effects on gastrointestinal motility, gut hormone release (motilin, ghrelin, glucagon-like peptide-1 (GLP-1) and insulin) and hunger feelings.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI<30 kg/m² for the lean volunteers
- •Female or male subjects aged 18 to 60
- •Subject is capable and willing to give informed consent
- •Female volunteers of child bearing potential must use oral, injected or implanted hormonal methods of contraception
排除标准
- •Female volunteer is pregnant or breastfeeding
- •GI diseases, major abdominal surgery
- •Volunteers that have food allergies, especially fructose intolerance
- •Major psychiatric illnesses
- •Volunteers that use drugs affecting the GI tract or the central nervous system
- •Volunteers suffering from an endocrine disease such as diabetes, Cushing's disease, Addison's disease, hypothalamic tumor
- •Volunteers that have undergone surgical procedure for weight loss
结局指标
主要结局
Change in gastrointestinal motility measured by antroduodenal high-resolution manometry
时间窗: 3 hours after administration, continuous measurement with high resolution manometry
次要结局
- Change in gut hormone release measured by specific radioactive immunoassays(3 hours after administration, blood sample every 15 min)
- Change in subjective hunger and satiety scores measured by visual analogue scales of 100 mm(3 hours after administration, assessment every 5 min)
研究者
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