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临床试验/NCT01456572
NCT01456572已完成1 期

Gastric and Intestinal Satiation in Obese and Normal Weight Healthy People

University Hospital, Basel, Switzerland2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2007年1月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
65
试验地点
2
主要终点
gastrointestinal peptide secretion

研究概览

简要总结

The purpose of this study is to determine the reciprocal control between gastric functions and intestinal parameters in the development of satiation in obese people.

详细描述

Obesity has reached pandemic proportions, obesity-associated complications are extensive and the current treatment options are limited. These facts demonstrate the need for an improved understanding of the pathogenesis of obesity. The gastrointestinal tract plays a key element in the control of satiation; discrepancies exist, however, for the role of gastric and intestinal parameters in the control of satiation in relation to body mass. To achieve a comprehensive understanding for the reciprocal control between gastric functions and intestinal parameters in the development of satiation in obese people the investigators will compare satiation parameters, gastric emptying and plasma glucagon-like peptide-1 (GLP-1), peptide tyrosine tyrosine (PYY) and ghrelin levels between normal and obese healthy volunteers.

Time needed to reach the level of satiation and total calorie intake will be measured by a standardized nutrient drink test; gastric emptying of solids by a 13C-octanoic acid breath test; and plasma GLP-1, PYY and ghrelin levels will be measured after a standardized nutrient drink.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • healthy subjects
  • age 18-45

排除标准

  • substance abuse
  • regular intake of medication
  • medical or psychiatric illness
  • gastrointestinal disorders or food allergies

研究组 & 干预措施

hormone profiles_obese weight

Active Comparator

Obese subjects will receive 500 mL of a complex nutrient drink (Ensure Plus; 17 % protein, 30 % fat and 53 % carbohydrate). At regular time intervals fasting and post-prandial blood samples will be collected.

干预措施: ensure plus (Dietary Supplement)

hormone profiles_normal weight

Placebo Comparator

Normal weight subjects will receive 500 mL of a complex nutrient drink (Ensure Plus; 17 % protein, 30 % fat and 53 % carbohydrate). At regular time intervals fasting and post-prandial blood samples will be collected.

干预措施: ensure plus (Dietary Supplement)

satiation_obese weight

Active Comparator

Obese subjects will receive a complex nutrient drink (Ensure Plus; 17 % protein, 30 % fat and 53 % carbohydrate, 1 kcal/mL). Nutrient intake will be stopped when subjects had reached maximal or unbearable satiation; the time needed to reach the maximal level of satiation (tmax) and the quantity of volume drunk will be recorded and calorie intake calculated.

干预措施: ensure plus (Dietary Supplement)

gastric emptying_obese weight

Active Comparator

Obese subjects will receive a standardized meal, consisting of two scrambled eggs (cooked with 10 g butter), placed on two slices of whole wheat bread and 200 mL of milk (in total: 468 kcal). The test meal will be labeled with 100 mg of 13C-octanoic acid for determination of gastric emptying.

干预措施: standardized test meal (Dietary Supplement)

gastric emptying_normal weight

Placebo Comparator

Normal weight subjects will receive a standardized meal, consisting of two scrambled eggs (cooked with 10 g butter), placed on two slices of whole wheat bread and 200 mL of milk (in total: 468 kcal). The test meal will be labeled with 100 mg of 13C-octanoic acid for determination of gastric emptying.

干预措施: standardized test meal (Dietary Supplement)

satiation_normal weight

Placebo Comparator

Normal weight subjects will receive a complex nutrient drink (Ensure Plus; 17 % protein, 30 % fat and 53 % carbohydrate, 1 kcal/mL). Nutrient intake will be stopped when subjects had reached maximal or unbearable satiation; the time needed to reach the maximal level of satiation (tmax) and the quantity of volume drunk will be recorded and calorie intake calculated.

干预措施: ensure plus (Dietary Supplement)

结局指标

主要结局

gastrointestinal peptide secretion

时间窗: 2 hours blood sampling

次要结局

  • total calorie intake(up to 30 min)
  • gastric emptying(240 minutes end-expiratory breath sample collection)
  • time needed to reach the level of satiation(up to 30 min)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (2)

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