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临床试验/NCT04938934
NCT04938934已完成不适用

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

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: 2021年6月24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
Difference in digestive well-being in response to a comfort meal before and after conditioning.

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 conditioning effect of previous digestive symptoms to a standardized probe meal.

Controlled randomized parallel study in healthy subjects on the conditioning effect of previous digestive symptoms on the responses to a comfort meal. Digestive symptoms will be induced by lipid (or sham) infusion into the intestine. On three separate days, digestive sensations (satiety, abdominal bloating, digestive well-being, mood, discomfort) in response to a comfort meal will be measured before, during and after the intervention. Primary outcome: effect of conditioning on the sensation of digestive well-being measured by -5 to +5 scale after a comfort meal. Secondary aim: effect of conditioning on abdominal on homeostatic sensations (satiety, fullness, discomfort, nausea).

Participants (16 women, 8 in the intestinal infusion and 8 in the sham intervention) 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 comfort meal will be administered 4 h after breakfast. Studies will be conducted in a quiet, isolated room. On each study day, participants will be intubated with a nasoduodenal feeding tube under fluoroscopic control for lipids or sham infusion. A comfort meal will be administered and perception of digestive sensations 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
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
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

Difference in digestive well-being in response to a comfort meal before and after conditioning.

时间窗: 120 minutes

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 a comfort meal before and after conditioning.

次要结局

  • Change in mood in response to a comfort meal before and after conditioning(120 minutes)
  • Change in hunger/satiety in response to a comfort meal before and after conditioning(120 minutes)
  • Difference in fullness sensation in response to a comfort meal before and after conditioning(120 minutes)
  • Change in discomfort in response to a comfort meal before and after conditioning(120 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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