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临床试验/NCT04722419
NCT04722419已完成不适用

Factors That Determine the Responses to Meal Ingestion in Functional Dyspepsia

Hospital Universitari Vall d'Hebron Research Institute2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2021年2月2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
42
试验地点
2
主要终点
Meal enjoyment

研究概览

简要总结

Background. Dyspeptic patients tolerate smaller meal loads than healthy subjects, but it is not known whether and to what extent symptoms relate to abnormal homeostatic or hedonic components of perception. Methods. Parallel studies in patients with symptoms induced by meals (fulfilling Rome IV criteria of postprandial dyspepsia) and sex- and age-matched healthy subjects. Participants 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 4 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Participants will ingest a probe meal up to the level of maximal satiation. The probe meal will be served stepwise (112 Kcal every 5 min). Perception of homeostatic (hunger/satiation, fullness) and hedonic (digestive well-being, mood) sensations will be measured at 5 min intervals 10 min before, during and 20 min after ingestion at 10 min intervals.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

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

Meal enjoyment

时间窗: 100 minutes

Amount of meal (Kcal) consumed up to the level of maximal digestive well-being measured on a - 5 (extremely unpleasant sensation) to + 5 scale (extremely pleasant sensation).

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 digestive well-being induced by the probe meal(1 day)
  • Change in abdominal discomfort 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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