OverweightNCT01719419
The Effect of Modified Sham Feeding With Orlistat in Overweight and Obese Subjects
A study testing Orlistat in people with Overweight, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if the drug orlistat (Alli, Xenical) decreases the taste for fat in humans. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Orlistat
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are a healthy male or female,
- Are between 18 to 70 years of age,
- Have a body mass index between 25-35 kg/m2
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: 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.
Read the 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.
- Conditions
- Overweight
- Being tested
- Placebo, Orlistat
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Measured fatty food intake and appetite at a single lunch meal after the administration of modified sham feeding technique with placebo.
OrlistatDrug
Measured fatty food intake and appetite at a single lunch meal after the administration of modified sham feeding technique with orlistat.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | Fatty food intake on the day the Modified sham feeding technique with placebo compared to the day modified sham feeding with orlistat. Receives: Drug: Placebo |
| Orlistat | Experimental | Fatty food intake on the day of the modified sham feeding technique with orlistat compared to the day with placebo. Receives: Drug: Orlistat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Greenway, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719419
- Sponsor's protocol ID
- PBRC 12014
- Status last verified
- Dec 2015
- First submitted
- 30 Oct 2012
- Last updated
- 18 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Modified Sham Feeding With Orlistat in Overweight and Obese Subjects: A Pilot Study
- ClinicalTrials.gov ID
- NCT01719419
- Acronym / sponsor ID
- PBRC 12014
- Conditions
- Overweight
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 1 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the drug orlistat (Alli, Xenical) decreases the taste for fat in humans.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Drug: PlaceboFatty food intake on the day the Modified sham feeding technique with placebo compared to the day modified sham feeding with orlistat. |
| Orlistat | Experimental | Drug: OrlistatFatty food intake on the day of the modified sham feeding technique with orlistat compared to the day with placebo. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Are a healthy male or female,
- Are between 18 to 70 years of age,
- Have a body mass index between 25-35 kg/m2
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboMeasured fatty food intake and appetite at a single lunch meal after the administration of modified sham feeding technique with placebo. | Drug | Placebo |
| OrlistatMeasured fatty food intake and appetite at a single lunch meal after the administration of modified sham feeding technique with orlistat. | Drug | Orlistat |
Primary outcome
Does orlistat decreases the taste for fatty food intake
Time frame: 1 month
* 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orlistat in people with Overweight, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Does orlistat decreases the taste for fatty food intake (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2015.