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临床试验/NCT03113305
NCT03113305已完成不适用

Changes in Ingestive Behaviour Following Gastric Bypass

University of Ulster2 个研究点 分布在 2 个国家目标入组 63 人开始时间: 2016年9月1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
63
试验地点
2
主要终点
Food intake

研究概览

简要总结

The gastric bypass procedure is known to be one of the most successful treatments for morbid obesity and Type 2 diabetes mellitus, and has been shown to decrease appetite, energy intake, body weight and glycemia both in the short and long term. A number of reports hypothesise that these changes may be driven, at least in part, by positive shifts in food preferences following surgery. However, findings are drawn from self-reported dietary intakes which are beset with measurement bias, thus precluding definite conclusions.

The current work aims to directly observe food intake to test the hypothesis that after gastric bypass food intake changes in a manner which leads to beneficial outcomes on body weight when compared to weight stable control participants. Patients (n=32) with a planned gastric bypass procedure will be recruited from Phoenix Health (Ireland and England) and Letterkenny University Hospital (Ireland), alongside control participants (n=32) with no planned weight loss. All subjects will attend the Human Intervention Studies Unit (HISU), Ulster University on five occasions (1-month pre-surgery and 3, 12, 24 and 60 months post-surgery, with controls being time-matched). Study visits will be fully residential involving two overnight stays within the facility during which participants' 24-hour food intake will be covertly measured (7am-11pm Day 2 and breakfast Day 3) and the following procedures undertaken; basal metabolic rate, body composition, bone health, assessment of liking/wanting high fat foods and post-meal gut hormone responses. On each study visit participants will have ad lib access to a range of foods of varying macronutrient composition and which are compatible with their stated food preferences (assessed prior to the start of the study). Changes in all ingestive behaviours will be evaluated over time as compared to the control participants.

研究设计

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

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

  • >18 years
  • Planned gastric bypass surgery (patients only)
  • No planned weight loss/gain (controls only)

排除标准

  • Significant dysphagia, gastric outlet obstruction or any other factor which prevents consumption of a meal
  • Systemic or gastrointestinal condition which may affect food intake or preference
  • Pregnancy / lactation
  • Significant food allergy or dietary restriction
  • Medication with documented effect on food intake or food preference
  • Any other physical or psychological condition which would affect the outcome of the study as determined by Phoenix Health care team.
  • Medication with documented effect on food intake / preference or study outcomes
  • Pregnancy / lactation
  • Significant food allergy or dietary restriction
  • Undertaking a weight-loss programme or planning to.

结局指标

主要结局

Food intake

时间窗: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery

Total energy density (kJ / gram)

次要结局

  • Food preferences(Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery)
  • Meal frequency(Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery)
  • Percentage body fat(Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery)
  • Bone health(Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery)
  • Plasma micronutrient status(Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery)
  • Total energy intake(Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery)
  • Basal Metabolic Rate(Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery)
  • Relative macronutrient intake(Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery)
  • Eating occasion size(Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery)
  • Eating speed(Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery)
  • Percentage lean weight(Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery)
  • Serum lipid profile(Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery)
  • Serum C-Reactive Protein(Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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