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

NCT ID: NCT01719419

Last Updated: 2015-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-09-30

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.

Conditions

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Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Fatty food intake on the day the Modified sham feeding technique with placebo compared to the day modified sham feeding with orlistat.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Measured fatty food intake and appetite at a single lunch meal after the administration of modified sham feeding technique with placebo.

Orlistat

Fatty food intake on the day of the modified sham feeding technique with orlistat compared to the day with placebo.

Group Type EXPERIMENTAL

Orlistat

Intervention Type DRUG

Measured fatty food intake and appetite at a single lunch meal after the administration of modified sham feeding technique with orlistat.

Interventions

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Placebo

Measured fatty food intake and appetite at a single lunch meal after the administration of modified sham feeding technique with placebo.

Intervention Type DRUG

Orlistat

Measured fatty food intake and appetite at a single lunch meal after the administration of modified sham feeding technique with orlistat.

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pennington Biomedical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Frank Greenway

Principal Investigaator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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PBRC 12014

Identifier Type: -

Identifier Source: org_study_id