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

Primary Purpose

Overweight

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo
Orlistat
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Placebo

Orlistat

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 30, 2012
Last Updated
December 17, 2015
Sponsor
Pennington Biomedical Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT01719419
Brief Title
The Effect of Modified Sham Feeding With Orlistat in Overweight and Obese Subjects
Official Title
The Effect of Modified Sham Feeding With Orlistat in Overweight and Obese Subjects: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Withdrawn
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Experimental
Arm Description
Fatty food intake on the day the Modified sham feeding technique with placebo compared to the day modified sham feeding with orlistat.
Arm Title
Orlistat
Arm Type
Experimental
Arm Description
Fatty food intake on the day of the modified sham feeding technique with orlistat compared to the day with placebo.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Measured fatty food intake and appetite at a single lunch meal after the administration of modified sham feeding technique with placebo.
Intervention Type
Drug
Intervention Name(s)
Orlistat
Intervention Description
Measured fatty food intake and appetite at a single lunch meal after the administration of modified sham feeding technique with orlistat.
Primary Outcome Measure Information:
Title
Does orlistat decreases the taste for fatty food intake
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States

12. IPD Sharing Statement

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

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