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

Pennington Biomedical Research Center

Status: Withdrawn

Conditions: Overweight

Treatments: Drug: Placebo; Drug: Orlistat

Study type: Interventional

Funder types: Other

Identifiers

NCT01719419

PBRC 12014

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Placebo

Experimental group

Description:

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

Treatment:

Drug: Placebo

Orlistat

Experimental group

Description:

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

Treatment:

Drug: Orlistat