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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

Page last updated: August 23, 2015

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