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临床试验/NCT03783221
NCT03783221已完成不适用

Factors That Determine the Responses to Meal Ingestion: Effect of Previous Diet

Hospital Universitari Vall d'Hebron Research Institute2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年10月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Change in digestive well-being induced by comfort meal

研究概览

简要总结

Meal ingestion induces digestive responses associated to homeostatic and hedonic sensations. The responses to meal ingestion are modulated by conditioning factors. Single-centre, cross-over, random, open label study comparing the effect of a high-fat/low-residue diet versus low-fat/high residue diet on the responses to meal ingestion. In 20 healthy subjects each diet will be administered during 2 weeks in random order; each diet will be preceded by 2 weeks washout, balanced diet. The aim of the study is to compare the effects of each diet on the responses to comfort and flatulogenic meals, intestinal gas production and digestive sensations.

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
All
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

研究组 & 干预措施

High-fat diet

Experimental

干预措施: High-fat diet (Other)

High-residue diet

Active Comparator

干预措施: High-residue diet (Other)

结局指标

主要结局

Change in digestive well-being induced by comfort meal

时间窗: 1 day

Change in digestive well-being measured by a 10 cm scale graded from -5 (extremely unpleasant sensation) to +5 (extremely pleasant sensation) in response to comfort meal during high-fat versus high-residue diet by repeated measures ANCOVA.

次要结局

  • Change in fullness sensation induced by comfort meal(1 day)
  • Change in hunger/satiety induced by comfort meal(1 day)
  • Change in mood induced by comfort meal(1 day)
  • Intestinal gas evacuation in response to a flatulogenic meal.(1 day)
  • Intestinal gas production(2 days)
  • Sensation of flatulence(2 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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