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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Overweight
• Intervention / Treatment: Drug: Placebo; Drug: Orlistat

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: October 30, 2012
• First Submitted That Met QC Criteria: October 31, 2012
• First Posted (Estimate): November 1, 2012

Study Record Updates

• Last Update Posted (Estimate): December 18, 2015
• Last Update Submitted That Met QC Criteria: December 17, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Lipid Regulating Agents; Anti-Obesity Agents; Orlistat
• Other Study ID Numbers: PBRC 12014