The Role of Induced Phase 3 Contractions in the Control of Hunger and Food Intake
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- Change in hunger ratings from time of administration over 6 hours
研究概览
简要总结
In this study, the investigators will evaluate if the food intake associated with the infusion of erythromycin is caused by the phase 3 contractions or by another yet unknown effect of erythromycin. To obtain this the investigators will use atropine, a muscarinic receptor antagonist, to inhibit the formation of contractions induced by a low dose of erythromycin
详细描述
The role of induced phase 3 contractions in the control of hunger and food intake
- Background In between meals the motor activity of the upper gastrointestinal tract is characterized by a cyclical pattern of contractions that consists of 3 phases: maximal contractile activity originating in the stomach and migrating down the small intestine (phase 3), followed by a phase of motor quiescence (phase 1) and a phase of progressively increasing motor activity (phase 2). In 1975 Itoh et. al. linked the phase 3 contractions of the migrating motor complex (MMC) to hunger sensations, by increasing the hunger sensations through exogenously administered motilin. The investigators previously demonstrated that phase 3 is associated with a 'hunger pang'. The trigger for the phase 3 initiation is unclear, but the gut hormones ghrelin and motilin are presumed to play a role. If either of these substances are administered intravenously, they induce a premature phase 3 in humans.
In previous studies, 'hunger pangs' could objectively be detected as peaks in subjective hunger ratings on a visual analog scale (VAS) using a custom made algorithm. A close association between phase 3 contractions of gastric origin and hunger peaks was observed and spontaneous food intake was also found to be associated with hunger peaks. By inducing phase 3 contractions through the administration of IV erythromycin, the time of food intake could be manipulated.
In a new study the investigators will evaluate if the food intake associated with the infusion of erythromycin is caused by the phase 3 contractions or by another yet unknown effect of erythromycin. To obtain this the investigators will use atropine, a muscarinic receptor antagonist, to inhibit the formation of contractions induced by a low dose of erythromycin. Since food intake is no longer a pure physiological act to still hunger sensations, it has obtained a social and emotional status in modern times where palatable food is abundant, the relationship of the subject towards food using multiple questionnaires will also be evaluated. 2. Aim To investigate whether contractions in the antrum are necessary to induce food intake with erythromycin or if erythromycin has a secondary effect to stimulate food intake. 3. Methodology 3.1. Subject selection Healthy volunteers will be recruited. See eligibility criteria for details
3.2. Questionnaires
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Erythromycin lactobionate
40 mg erythromycin lactobionate was administered over a 20 min period in a volume of 100 ml sodium chloride 0.9 %
干预措施: erythromycin lactobionate (Drug)
Erythromycin lactobionate with atropine
40 mg erythromycin lactobionate was administered over a 20 min period in a volume of 100 ml sodium chloride 0.9 %; Atropine sulfate was given as an i.v. bolus (15 µg/kg) followed by a continuous infusion of 15 µg/kg/h over 30 min
干预措施: Erythromycin with atropine (Drug)
Atropine
Atropine sulfate was given as an i.v. bolus (15 µg/kg) followed by a continuous infusion of 15 µg/kg/h over 30 min.
Infusion of saline as a placebo for erythromycin was administered over a 20 min period in a volume of 100 ml sodium chloride 0.9 %
干预措施: Atropine (Drug)
Placebo
Infusion of saline was administered over a 20 min period in a volume of 100 ml sodium chloride 0.9 %; also placebo for atropine was given as an i.v. bolus of saline followed by a continuous infusion over 30 min
干预措施: Saline (Drug)
结局指标
主要结局
Change in hunger ratings from time of administration over 6 hours
时间窗: 6 hours after intervention, assessment every 5 minutes
visual analog scale
次要结局
- Timing of food intake(6 hours after intervention; up to 2 moments of food intake allowed)
