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临床试验/NCT03084276
NCT03084276已完成不适用

Factors That Determine the Responses to Meal Ingestion: Meal Composition

Hospital Universitari Vall d'Hebron Research Institute1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年1月16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
12
试验地点
1
主要终点
Change in digestive well-being measured after the test meal

研究概览

简要总结

Aim: to determine to what extent meal composition influences postprandial sensations independently of palatability. The postprandial responses to a low-fat (240 Kcal) versus a high-fat (275 Kcal) test meal (150 g humus) with the same physical and organoleptic characteristics (taste, smell, colour, texture, consistency, temperature) will be studied on a cross-over design. The responses to the meals will be tested on 2 different days. Participants (12 non-obese healthy 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 3 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Perception 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
Triple (Participant, Investigator, Outcomes Assessor)

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
是

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 meal

Experimental

干预措施: High-fat meal (Other)

Low-fat meal

Active Comparator

干预措施: Low-fat meal (Other)

结局指标

主要结局

Change in digestive well-being measured after the test meal

时间窗: 1 day

Change in average well-being measured by 10 score scales at the end of the test meal.

次要结局

  • Change in satiety measured after the test meal(1 day)
  • Change in mood measured after the test meal(1 day)
  • Change in fullness sensation measured after the test meal(1 day)
  • Change in abdominal discomfort/pain sensation measured after the test meal(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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