The Effect of Modified Sham Feeding With Orlistat in Overweight and Obese Subjects

Study Overview
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Brief Summary
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The purpose of this study is to determine if the drug orlistat (Alli, Xenical) decreases the taste for fat in humans.

Detailed Description
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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.

Official Title
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The Effect of Modified Sham Feeding With Orlistat in Overweight and Obese Subjects: A Pilot Study

Conditions
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Overweight

Intervention / Treatment
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* Drug: Placebo
* Drug: Orlistat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are a healthy male or female, Are between 18 to 70 years of age, Have a body mass index between 25-35 kg/m2 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo<br>Fatty food intake on the day the Modified sham feeding technique with placebo compared to the day modified sham feeding with orlistat. | Drug: Placebo<br>* Measured fatty food intake and appetite at a single lunch meal after the administration of modified sham feeding technique with placebo.<br>|
| Experimental: Orlistat<br>Fatty food intake on the day of the modified sham feeding technique with orlistat compared to the day with placebo. | Drug: Orlistat<br>* Measured fatty food intake and appetite at a single lunch meal after the administration of modified sham feeding technique with orlistat.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Does orlistat decreases the taste for fatty food intake | 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. | 1 month |