The Role of Bitter Taste Receptors Expressed in the Gastrointestinal Tract in Altering Food Intake and Gastrointestinal Motility
试验速览
- 阶段
- 不适用
- 入组人数
- 98
- 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 bitter taste receptors in the gastrointestinal tract (GIT). Intragastric or intraduodenal administration of denatonium benzoate (DB) or quinine hydrochloride were compared with placebo administration for their effects on lingual sensitivity, gastrointestinal motility (both in the fasted and fed state), gut hormone release (motilin, ghrelin, glucagon-like peptide-1 (GLP-1) and cholecystokinin (CCK)) and food intake. Differences between lean and obese subjects will be evaluated.
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
- Single (Participant)
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 obese volunteers
- •BMI<30 kg/m² for the lean volunteers
- •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
- •Gastrointestinal diseases, major abdominal surgery
- •Major psychiatric illnesses
- •Volunteers that use drugs affecting the GIT or the central nervous system (CNS)
- •Volunteers that suffer from diabetes mellitus
- •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
研究组 & 干预措施
Denatonium benzoate intragastric
1 µmol/kg bodyweight (10mM) was administered as a bolus into the stomach through a nasogastric feeding tube.
干预措施: Denatonium benzoate (Drug)
Quinine hydrochloride intragastric
10 µmol/kg bodyweight (100mM) was administered as a bolus into the stomach through a nasogastric feeding tube.
干预措施: Quinine hydrochloride (Drug)
Tap water intragastric
An equal amount of tap water was administered as a bolus into the stomach through a nasogastric feeding tube.
干预措施: Tap water (Drug)
Denatonium benzoate intraduodenal
1 µmol/kg bodyweight (10mM) was administered as a bolus into the proximal part of the duodenum through a nasogastric feeding tube.
干预措施: Denatonium benzoate (Drug)
Quinine hydrochloride intraduodenal
10 µmol/kg bodyweight (100mM) was administered as a bolus into the proximal part of the duodenum through a nasogastric feeding tube.
干预措施: Quinine hydrochloride (Drug)
Tap water intraduodenal
An equal amount of tap water was administered as a bolus into the proximal part of the duodenum through a nasogastric feeding tube.
干预措施: Tap water (Drug)
结局指标
主要结局
Change in gastrointestinal motility measured by antroduodenal high-resolution manometry
时间窗: 2 hours after administration, continuous measurement with high resolution manometry
次要结局
- Change in gut hormone release measured by specific radioactive immunoassays(2 hours after administration, blood sample every 10 min)
- Change in food intake measured by the caloric content of the meal(ad libitum food intake for 1 hour, 40 min after administration)
- Change in subjective hunger and satiety scores measured by visual analogue scales of 100 mm(2 hours after administration, assessment every 5 min)