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临床试验/NCT03363581
NCT03363581已完成不适用

Food Preference Following Bariatric Surgery

Imperial College London1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2017年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Total Food Intake (Lunch Buffet) at 24 Months

研究概览

简要总结

Roux-en-Y gastric bypass (RYGB) decreases appetite, caloric intake, glycemia, and body weight, all of which are maintained long term.It is controversial whether, after RYGB, patients choose to eat less high fat and sugary foods in favor of lower energy dense alternatives. Therefore the proposition to use direct measures in humans after RYGB to test the hypothesis that the selection and intake of foods varying in fat content and glycemic index, as well as the pattern of ingestion within and across meals, changes in a manner that leads to beneficial outcomes on body weight.

详细描述

Roux-en-Y gastric bypass (RYGB) decreases appetite, caloric intake, glycemia, and body weight, all of which are maintained long term.It is controversial whether, after RYGB, patients choose to eat less high fat and sugary foods in favor of lower energy dense alternatives. If true, this could conceivably contribute to improved glycemia and body weight. Disparities among studies on food selection and intake are likely due to the almost complete reliance on self-reported food intake which is vulnerable to inaccuracy.This controversy can best be resolved by complementing existing findings with direct measures of target behaviour in humans. Therefore the proposition to use direct measures in humans after RYGB to test the hypothesis that the selection and intake of foods varying in fat content and glycemic index, as well as the pattern of ingestion within and across meals, changes in a manner that leads to beneficial outcomes on body weight.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Surgical and non-surgical groups:
  • A) Bariatric surgery B) Controls with no history of bariatric surgery
  • Independently mobile
  • Capacity to consent to participate
  • >18 years of age

排除标准

  • Pre-operatively: significant dysphagia, gastric outlet obstruction or anything that prevents subjects from eating a meal.
  • Post-operatively: significant and persistent surgical complications or anything that prevents subjects from eating a meal.
  • Systemic or gastrointestinal condition which may affect food intake or preference, including:
  • i) pregnancy or ii) breast feeding.
  • Active and significant psychiatric illness including substance misuse
  • Significant cognitive or communication issues
  • Medications with documented effect on food intake or food preference
  • History of significant food allergy and certain dietary restrictions
  • History of liver disease or pancreatitis
  • History of bradyarrythmia or congestive cardiac failure group)
  • Use of medications with potential serious interactions with Octreotide

结局指标

主要结局

Total Food Intake (Lunch Buffet) at 24 Months

时间窗: 24 months

Determine the effect of RYGB on total food intake from an ad libitum lunch buffet

Change in Absolute Intake of Carbohydrates

时间窗: 24 months

Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of carbohydrates from an ad libitum lunch buffet

Change in Absolute Intake of Fat

时间窗: 24 months

Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of fat from an ad libitum lunch buffet

Change in Absolute Intake of Protein

时间窗: 24 months

Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of protein from an ad libitum lunch buffet

Change in Absolute Intake of Sugar

时间窗: 24 months

Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of sugar from an ad libitum lunch buffet

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carel Le Roux

Reader in Investigative Science

Imperial College London

研究点 (1)

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