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临床试验/NCT06139237
NCT06139237尚未招募不适用

Factores Que Determinan la Respuesta a la Ingesta: Efecto de la Carga Proteica

Hospital Universitari Vall d'Hebron Research Institute2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2023年11月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
16
试验地点
2
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. Experimental design: randomized cross-ower study comparing the responses to a high protein (47.3% protein, 39.4% carbohydrates, 13.3% lipids) versus a balanced (22.2% protein, 67.85% carbohydrates, 9.95% lipids). In each participant the meals (both containing 20.8 g protein and diluted to a volume of 200 mL) will be tested on separate days. Healthy, non-obese participants (8 men and 8 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 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, at 10 min intervals up to 60 min after the meal and at 30 min up to 120 min after ingestion. Blood samples for biochemical and hormonal determinations will be taken before and after ingestion.

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
Single (Participant)

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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