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临床试验/NCT03540693
NCT03540693Unknown不适用

Fat Taste Sensory Study

University of Illinois at Urbana-Champaign1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2018年4月6日最近更新:
适应症

试验速览

阶段
不适用
入组人数
105
试验地点
1
主要终点
Flavor perception

研究概览

简要总结

Fat is the most energy dense macronutrient and consuming fat has been positively correlated to obesity. Individuals afflicted with obesity crave fat more frequently, have a higher preference for fatty taste, and consume a higher quantity of fatty foods. People who have undergone Roux-en-Y Gastric Bypass (RYGB) or Sleeve Gastrectomy (SG) weight-loss surgeries dramatically decrease their fat preferences and consumption of fat, at least within the first year after surgery. These surgeries are very effective in helping people lose weight over the first couple of years; however, approximately 30% of those who undergo these surgeries start regaining weight after the second year mark. Why some people are able to keep the weight off long-term but others are unable to is unclear. In addition, it is well-known that fat can modify the flavor of foods and flavor plays a critical role in consumption, as well as in responses that gear up the body to consume the food. These are known as cephalic phase responses and include neural, physiological, and hormonal aspects. The main goals of the study are twofold: 1) To test the immediate effects of RYGB surgery, SG surgery, and laparoscopic gastric banding (LAGB) surgery (a weight loss control group) on fat preferences and sensory perception, and 2) to compare fat preferences and sensory perception between those who are able to achieve sustained weight loss 2-5 years after RYGB or SG surgery and those who either regained weight or did not lose the desired amount.

详细描述

For the first goal, the investigators will assess a longitudinal group of subjects both before RYGB surgery (n=15) SG surgery (n=15), and LAGB surgery (n=15), and then again after they lose ~16% of their body weight post-surgery in the fed and the fasted state. the investigators will also study the same variables in a cross-sectional design consisting of two groups: a weight success group (n=30) and a weight failure group (n=30) 2-5 years post RYGB or SG surgery. The weight success group will include subjects who lost ≥40% body weight by 2-5 years post-surgery and the weight failure group will include subjects who lost <25% body weight by 2-5 years post-surgery. In addition, the investigators will also explore the extent to which fat preferences and sensory perception in these subjects are affected by flavor related genes.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Women and men, 18-64 years of age, all races
  • Subjects must be scheduled to undergo Roux-en-Y Gastric Bypass surgery (RYGB), Sleeve Gastrectomy surgery (SG), or laparoscopic gastric banding surgery (LAGB) and be available to be tested both pre- and post-surgery or must have undergone RYGB or SG surgery between 2-5 (i.e. at least two years ago and not more than 5) years ago and have a current weight loss that is ≥40% of body weight pre-surgery or <25% of body weight pre-surgery.

排除标准

  • Smoking tobacco related cigarettes or having quit smoking less than 6 months ago
  • Pregnant or breastfeeding
  • Are experiencing significant organ dysfunction
  • Take medications that could influence research results
  • Have any psychiatric illness or disorder that could influence compliance or completion of the study
  • History of chronic rhinitis
  • Had a diagnosis of or are taking medicine to treat diabetes
  • Inflammatory intestinal disease
  • Subjects who underwent RYGB or SG between 2-3 years ago and have a current weight loss that is <40% and ≥25% of their body weight pre-surgery.
  • Subjects must find the taste of the food to be sham-fed acceptable (e.g. cream cheese, etc.).

结局指标

主要结局

Flavor perception

时间窗: 3-6 months

Changes in perception of flavor intensity in the general label magnitude scale (in mm)

Flavor preference

时间窗: 3-6 months

Changes in perception of hedonic value in the hedonic version of the general label magnitude scale (in mm)

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

Marta Yanina Pepino de Gruev

Assisstant Professor of Ingestive Behavior

University of Illinois at Urbana-Champaign

研究点 (1)

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