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

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01719419
• Other study ID #: PBRC 12014
• Status: Withdrawn
• Phase: N/A
• First received: October 30, 2012
• Last updated: December 17, 2015
• Start date: March 2012
• Est. completion date: September 2012

Study information

• Verified date: December 2015
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Overweight

Intervention

Drug:
• Placebo
Measured fatty food intake and appetite at a single lunch meal after the administration of modified sham feeding technique with placebo.
• Orlistat
Measured fatty food intake and appetite at a single lunch meal after the administration of modified sham feeding technique with orlistat.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No