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临床试验/NCT03827707
NCT03827707已完成不适用

Factors That Determine the Responses to Meal Ingestion: Effect of Ambient Noise

Hospital Universitari Vall d'Hebron Research Institute2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2018年10月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Change in digestive well-being induced by the probe meal

研究概览

简要总结

Meal ingestion induces sensations that are influenced by a series of conditioning factors. Aim: to determine the effect of ambient noise on the sensory responses to a standard probe meal. Randomized, cross-over study in healthy subjects comparing the effect of ambient noise versus silence on the sensations induced by a probe meal. Participants (12 men) will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the test meal will be administered 5 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. One study day, a noise will applied via headphones for 60 min after meal ingestion and the other day headphones without sound will applied. Perception of homeostatic sensations (hunger/ satiation, fullness) and hedonic sensations (digestive well-being, mood) will be measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals up to 60 min after the probe meal.

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
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • non-obese

排除标准

  • history of gastrointestinal symptoms
  • prior obesity
  • use of medications
  • history of anosmia and ageusia
  • current dieting
  • alcohol abuse
  • psychological disorders
  • eating disorders

结局指标

主要结局

Change in digestive well-being induced by the probe meal

时间窗: 1 day

Effect of noise on digestive well-being \[measured by a 10 cm scale graded from -5 (extremely unpleasant sensation) to +5 (extremely pleasant sensation)\] by repeated measures ANCOVA (dependent variable: postprandial sensations scores; within subject's factors: noise and time; covariate: premeal scores).

次要结局

  • Change in fullness sensation induced by the probe meal(1 day)
  • Change in hunger/satiety induced by the probe meal(1 day)
  • Change in mood induced by the probe meal(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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