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临床试验/NCT03773432
NCT03773432已完成不适用

Factors That Determine the Responses to Meal Ingestion: Meal Schedule and Gender Differences

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8月13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 meal schedule

研究概览

简要总结

Gender differences in the effect of meal schedule will be studied in a parallel design (10 women and 10 men). In two separate days a probe meal (290 stewed beans, 35 g bread, 100 mL water; 549 Kcal) will be administered in the afternoon, i.e. conventional schedule, and in the morning, i.e. unconventional schedule. The effect of meal schedule will be measured as the differences between the responses on both study days. Participants will be instructed to eat standard dinner the day before and to consume standard breakfast at home the day of the afternoon test. Studies will be conducted in a quiet, isolated room with participants siting 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
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

Men

Other

In two separate days a probe meal (290 stewed beans, 35 g bread, 100 mL water; 549 Kcal) will be served at conventional and unconventional time.

干预措施: Probe meal (Other)

Women

Other

In two separate days a probe meal (290 stewed beans, 35 g bread, 100 mL water; 549 Kcal) will be served at conventional and unconventional time.

干预措施: Probe meal (Other)

结局指标

主要结局

Change in digestive well-being induced by meal schedule

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 afternoon and morning meals by repeated measures ANCOVA.

次要结局

  • Change in hunger/satiety induced by meal schedule(1 day)
  • Change in fullness sensation induced by meal schedule(1 day)
  • Change in mood induced by meal schedule(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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