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临床试验/NCT01102907
NCT01102907已完成不适用

Beverages and Obesity: Effect of Food Form on Satiety and Hunger

University of Minnesota1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Determine whether food form (liquid vs. solid) alters gastric emptying time when all macronutrients and fiber are controlled.

研究概览

简要总结

Our objective is to determine whether food form (liquid vs. solid) alters gastric emptying, satiety, and food intake, when all macronutrients and fiber are controlled. The study population will include 10 healthy women, who have a normal body mass index. We have chosen to evaluate only women because this is a small pilot study and one of our endpoints is gastric emptying. Gastric emptying is known to differ between men and women. Gastric emptying will be evaluated using the Smartpill technology, satiety will be evaluated using computerized visual analog scales/questions, and food intake will be measured by providing subjects with an ad libitum/buffet-style lunch.

Our hypothesis is that our subjects will be less hungry after they eat a solid breakfast compared to a liquid breakfast. We also hypothesize that our subjects will have a slower gastric emptying time after they eat the solid meal. Lastly, we think subjects will want to eat less food at lunch time if they have eaten a solid meal compared to a liquid meal for breakfast.

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 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Healthy women
  • Age 18 - 35
  • Body mass index in the healthy range between 18.5 and 25
  • Proficient English speakers
  • Non-smoking
  • Not taking medications
  • Non-dieting (weight stable over last 3 months)
  • Able to swallow a large capsule

排除标准

  • Irregular or erratic breakfast eating patterns
  • Food allergies to ingredients commonly found in test products or pizza
  • Distaste for test products or pizza
  • BMI less than 18.5 or greater than 25
  • Weight change > 5 kg in last 3 months (intentional or unintentional)
  • Difficulty swallowing
  • Cardiovascular disease
  • Diabetes mellitus (fasting blood sugar > 126 mg/dl)
  • Cancer in prior 5 years (except basal cell carcinoma of skin)
  • Kidney or liver disease
  • Any gastrointestinal conditions that may affect digestion and absorption
  • Recent bacterial infection (< 3 months)
  • Chronic medication use
  • History of drug or alcohol abuse in prior 6 months
  • Concurrent or recent intervention study participation
  • Vegetarians or people who ate more than approximately 15 g of fiber per day
  • Pregnant or lactating women
  • Women with irregular menstrual cycles

结局指标

主要结局

Determine whether food form (liquid vs. solid) alters gastric emptying time when all macronutrients and fiber are controlled.

时间窗: May 2010 to December 2010

Subjects will consume both liquid and solid meals and we will evaluate and compare gastric emptying time after each of them.

次要结局

  • Determine whether food form (liquid vs. solid) alters satiety and food intake when all macronutrients and fiber are controlled.(May 2010 to December 2010)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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