The Effect of Modified Sham Feeding With Orlistat in Overweight and Obese Subjects: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Does orlistat decreases the taste for fatty food intake
研究概览
简要总结
The purpose of this study is to determine if the drug orlistat (Alli, Xenical) decreases the taste for fat in humans.
详细描述
One screening visit and Testing Visits 1 and 2: Approximately 1-2 hours (Fasting - You will have nothing to eat or drink (except water or medications) after midnight before the test visit.) If you qualify for the study, you will return to Pennington Biomedical Research Center for the test visit
- You will be given a questionnaire to screen for allergies or cold symptoms.
- Women will answer a questionnaire based on their menstrual cycle.
- Before eating, you will be given instructions on how to use the study medication. You will swish about 2 teaspoons of a solution in your mouth for 30 seconds and then spit it out (like mouthwash).
- Just before eating, you will be given another brief questionnaire judging your appetite.
- You will be given the test meal. You will be allowed to eat as much or as little as you like during a 20-minute eating period.
- 30 minutes after starting your meal you will be given the brief questionnaire again to judge your appetite.
- You will return in 1 month to complete test visit 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are a healthy male or female,
- •Are between 18 to 70 years of age,
- •Have a body mass index between 25-35 kg/m2
排除标准
- •Are a female who is pregnant or nursing,
- •Are a restrained eater (determined using a questionnaire),
- •Have any current illnesses such as an infection,
- •Have any serious medical problems including kidney, liver, heart or lung disease,
- •Use medications known to increase appetite,
- •Are taking any medication that has not been on the same dose for at least 30 days,
- •Dislike the test food.
研究组 & 干预措施
Placebo
Fatty food intake on the day the Modified sham feeding technique with placebo compared to the day modified sham feeding with orlistat.
干预措施: Placebo (Drug)
Orlistat
Fatty food intake on the day of the modified sham feeding technique with orlistat compared to the day with placebo.
干预措施: Orlistat (Drug)
结局指标
主要结局
Does orlistat decreases the taste for fatty food intake
时间窗: 1 month
* Before eating, you will be given instructions on how to use the study medication. You will swish about 2 teaspoons of a solution in your mouth for 30 seconds and then spit it out (like mouthwash). * Just before eating, you will be given another brief questionnaire judging your appetite. * You will be given the test meal. You will be allowed to eat as much or as little as you like during a 20-minute eating period. * 30 minutes after starting your meal you will be given the brief questionnaire again to judge your appetite. * You will return in 1 month to complete test visit 2.
次要结局
未报告次要终点
研究者
Frank Greenway
Principal Investigaator
Pennington Biomedical Research Center