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临床试验/NCT03758482
NCT03758482已完成不适用

Factors That Determine the Responses to Meal Ingestion: Effect of Gender on Sensory and Metabolomic Responses

Hospital Universitari Vall d'Hebron Research Institute2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年6月25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
24
试验地点
2
主要终点
Fullness sensation induced by the probe meal

研究概览

简要总结

Aim: to determine the effect of gender on the sensory and metabolomic responses to a standard probe meal. Participants (12 men and 12 women) 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 standard probe meal (750 Kcal). Perception of homeostatic sensations (hunger/satiation, fullness) and hedonic sensations (digestive well-being, mood) 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. Heart rate variability, blood pressure and body temperature were measured before and after the meal. Blood samples for metabolomic analysis were taken before and 30 min after the 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

The probe meal consists of: 50 g fatty liver duck, 15 g toasts, 50 g cheese, 25 g potato chips, 10 g salted peanuts and 140 mL soft drink.

干预措施: Probe meal (Other)

Women

Other

The probe meal consists of: 50 g fatty liver duck, 15 g toasts, 50 g cheese, 25 g potato chips, 10 g salted peanuts and 140 mL soft drink.

干预措施: Probe meal (Other)

结局指标

主要结局

Fullness sensation induced by the probe meal

时间窗: 1 day

Gender differences in fullness sensation \[(measured by a 10 cm scale graded from 0 (not at all) to 10 (very much)\] by repeated measures ANCOVA (dependent variable: postprandial sensations scores; between and within subject's factors: gender and time, respectively; covariate: premeal scores).

次要结局

  • Change in hunger/satiety induced by the probe meal(1 day)
  • Change in mood induced by the probe meal(1 day)
  • Change in digestive well-being induced by the probe meal(1 day)
  • Change in circulating metabolites 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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