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临床试验/NCT04691882
NCT04691882已完成不适用

Factors That Determine the Responses to Meal Ingestion: Effect of Abdominal Wall Activity

Hospital Universitari Vall d'Hebron Research Institute1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2020年10月12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
16
试验地点
1
主要终点
Changes in abdominal fullness/bloating sensation induced by the probe meal

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 effect of abdominal wall activity on the responses to a standard probe meal. Study in healthy subjects comparing postprandial digestive sensations (abdominal bloating and digestive well-being) during consecutive maneuvers of diaphragmatic contraction (i.e. descent) versus diaphragmatic relaxation (i.e. ascent) in a cross-over randomized design. Primary outcome: effect of somatic maneuvers on abdominal bloating sensation; secondary aim: effect on digestive well-being.

Participants (16 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. Participants will be taught to produce diaphragmatic contraction and visible abdominal distention. A probe meal up to maximal satiation will be administered to induce abdominal fullness/bloating sensation; immediately after ingestion, bloating sensation (from 0 to 10) and digestive well-being (from -5 to +5) will be scored during 8 alternating episodes (30 s each) in random sequence of diaphragmatic contraction (abdominal distension) versus diaphragmatic relaxation.

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
None

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
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

Diaphragmatic contraction

Experimental

干预措施: Diaphragmatic contraction (Behavioral)

Diaphragmatic relaxation

Active Comparator

干预措施: Diaphagmatic relaxation (Behavioral)

结局指标

主要结局

Changes in abdominal fullness/bloating sensation induced by the probe meal

时间窗: 10 min

Effect of abdominal wall activity on abdominal fullness/bloating \[measured by 10 cm scale graded from 0 (not at all) to 10 (very much)\]

次要结局

  • Changes in digestive well-being sensation induced by the probe meal(10 min)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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