Evaluate a Medication on How Hunger and Appetite Are Influenced by Smell
Information source: Pennington Biomedical Research Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Food Intake
Intervention: Placebo spray (Other); Diltiazem (Drug)
Phase: Phase 1
Status: Terminated
Sponsored by: Pennington Biomedical Research Center Official(s) and/or principal investigator(s):
Frank L. Greenway, MD, Principal Investigator, Affiliation: Pennington Biomedical Research Center
Summary
The purpose of this study is to determine whether the blood pressure medication, diltiazem,
will temporarily decrease the sense of smell when given in a nasal spray which will then
reduce food intake.
Clinical Details
Official title: A Single Dose Pilot Study to Evaluate the Safety and Dose-Response of Smell to Intranasal Diltiazem
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Evidence of blood pressure medication, diltiazem, will temporarily decrease the sense of smell when given in a nasal spray.
Detailed description:
You will fast on your first visit. Complete questionnaire about taste and smell to insure
you don't have a cold or anything that would interfere with sense of smell. Your nose will
be checked. Blood pressure taken, and administer to you a spray with diltiazem 2, 4, 8 mg
or a placebo. Your sense of smell will be tested at different time points.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Body mass index (BMI) between 25 and 40 kg
- Blood pressure in within normal range
Exclusion Criteria:
- Used tobacco products in the past month
- Used a calcium channel blocker medication in the last month
- used nasal sprays in the last month
- have an abnormal sense of smell or abnormalities of the lining in your nose
- female and have irregular menstrual periods
- female and are nursing a baby or pregnant
- female and have had a partial hysterectomy (still have ovaries)
Locations and Contacts
Pennington Biomedical Research Center, Baton Rouge, Louisiana 70808, United States
Additional Information
Starting date: October 2009
Last updated: May 21, 2012
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