ACTRN12619000813189已完成未知
Effects of intraduodenal Amarasate™ extract (bitter agonist), on upper gastrointestinal (GI) functions and energy intake in healthy, lean volunteers.
Professor Christine Feinle-Bisset0 个研究点目标入组 15 人开始时间: 2019年6月4日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 15
研究概览
简要总结
In healthy men, intraduodenal administration of Amarasate, at the dose of 250 mg, had modest, and transient effects to stimulate pyloric pressures during the first 90 min post-administration and a significant effect to stimulate PYY beyond 60 min post-administration, but, at both doses of 100 and 250 mg, had no effect on CCK, appetite perceptions and gastrointestinal symptoms or energy intake.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- Male
入选标准
- •A total of 12 healthy, lean (BMI 19-25 kg/m2) male subjects, aged between 18 - 60 years will be included. Subjects will be required to be weight stable (ie <5% fluctuation) at study entry, which will be ascertained by a stable body weight in the preceding 4 weeks.
排除标准
- •Significant GI symptoms, disease or surgery
- •Use of prescribed or non-prescribed medications (including vitamins and herbal Supplements) which may affect energy metabolism, GI function, body weight or appetite (eg domperidone, cisapride, anticholinergic drugs (eg atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St Johns Wort etc.)
- •Lactose intolerance/other food allergy(ies), including hops allergy, diagnosed idiopathic anaphylaxis or occupational exposure to hops (hops pickers, brewers)
- •Current gallbladder or pancreatic disease
- •Cardiovascular or respiratory diseases
- •Individuals with low ferritin levels (females <15 ng/mL, males <30 ng/mL), or who have donated blood in the 12 weeks prior to taking part in the study
- •Any other illnesses as assessed by the investigator (including chronic illnesses not explicitly listed above)
- •High performance athletes
- •Current intake of > 2 standard drinks on > 5 days per week
- •Current smokers of cigarettes/cigars/marijuana
- •Recreational drug use
- •Current intake of any illicit substance
- •Vegetarians
- •Inability to tolerate nasogastric tube
- •Inability to comprehend study protocol
- •Restrained eaters (score >12 on the 3-factor eating questionnaire)
研究者
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