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临床试验/NCT02997917
NCT02997917已完成不适用

Factors That Determine the Response to Meal Ingested: Education

Hospital Universitari Vall d'Hebron Research Institute1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2016年11月1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
28
试验地点
1
主要终点
Change in digestive well-being measured after a test meal by the end of the intervention versus before.

研究概览

简要总结

The effect of education on the responses to a probe meal (250 mL vegetable soup cooked at low temperature and 25 g bread) will be studied in a parallel design. The effects of education will be tested in two different groups in random order: real versus sham education. In each group the responses to a probe meal will be tested on 2 different days before and after the intervention. 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 probe 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
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
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

Education

Experimental

Solutions of the five basic tastes (sweet, salty, sour, bitter and umami) and the 3 main components of the probe soup (onion, leek and carrot) will be given every 10 min with a mouthwash after each test. In the real education group, solutions at suprathreshold concentration for detection will be given with a subsequent comment on the flavor and an explanation of the components and preparation of the soup (low temperature cooking to preserve flavors).

干预措施: Education (Behavioral)

Sham

Sham Comparator

Solutions of the five basic tastes (sweet, salty, sour, bitter and umami) and the 3 main components of the probe soup (onion, leek and carrot) will be given every 10 min with a mouthwash after each test. In the sham education group solutions at subthreshold concentration for detection with no explanation will be provided.

干预措施: Sham (Behavioral)

结局指标

主要结局

Change in digestive well-being measured after a test meal by the end of the intervention versus before.

时间窗: 1 day

Change in average well-being measured by 0-10 score scales at the end of the test meal administered before and after intervention.

次要结局

  • Change in fullness sensation measured after a test meal by the end of the intervention versus before.(1 day)
  • Change in satiety measured after a test meal by the end of the intervention versus before(1 day)
  • Change in discomfort/pain measured after a test meal by the end of the intervention versus before(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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