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

This study is currently recruiting participants.
Verified October 2012 by Pennington Biomedical Research Center
Sponsor:
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01719419
First received: October 30, 2012
Last updated: October 31, 2012
Last verified: October 2012
History of Changes
  Purpose

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


Condition Intervention
Overweight
 Drug: Placebo
Drug: Orlistat

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Modified Sham Feeding With Orlistat in Overweight and Obese Subjects: A Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Obesity
Drug Information available for: Orlistat
U.S. FDA Resources

Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Does orlistat decreases the taste for fatty food intake [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    • 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.


Estimated Enrollment: 10
Study Start Date: October 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01719419

Contacts
Contact: Frank L. Greenway, MD 225-763-3000 doctors@pbrc.edu

Locations
United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: recruiters     225-763-3000     recruiters@pbrc.edu    
Contact: Frank Greenway, MD         doctors@pbrc.edu    
Principal Investigator: Robert Dubin, MD            
Sub-Investigator: Frank Greenway, MD            
Sub-Investigator: Corby Martin, PhD            
Sub-Investigator: Stefany Primeaux, PhD            
Sponsors and Collaborators
Pennington Biomedical Research Center
  More Information

No publications provided

Responsible Party: Frank Greenway, Principal Investigaator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01719419     History of Changes
Other Study ID Numbers: PBRC12014
Study First Received: October 30, 2012
Last Updated: October 31, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms
Orlistat
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013