The Effect of Modified Sham Feeding With Orlistat in Overweight and Obese Subjects
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The purpose of this study is to determine if the drug orlistat (Alli, Xenical) decreases the taste for fat in humans.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 30, 2012
CompletedFirst Posted
Study publicly available on registry
November 1, 2012
CompletedDecember 18, 2015
December 1, 2015
6 months
October 30, 2012
December 17, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Placebo
EXPERIMENTALFatty food intake on the day the Modified sham feeding technique with placebo compared to the day modified sham feeding with orlistat.
Orlistat
EXPERIMENTALFatty food intake on the day of the modified sham feeding technique with orlistat compared to the day with placebo.
Interventions
Measured fatty food intake and appetite at a single lunch meal after the administration of modified sham feeding technique with placebo.
Measured fatty food intake and appetite at a single lunch meal after the administration of modified sham feeding technique with orlistat.
Eligibility Criteria
You may qualify if:
- Are a healthy male or female,
- Are between 18 to 70 years of age,
- Have a body mass index between 25-35 kg/m2
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigaator
Study Record Dates
First Submitted
October 30, 2012
First Posted
November 1, 2012
Study Start
March 1, 2012
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
December 18, 2015
Record last verified: 2015-12