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Evaluate a Medication on How Hunger and Appetite Are Influenced by Smell

Phase 1
Terminated
Conditions
Food Intake
Interventions
Other: Placebo spray
Registration Number
NCT01021176
Lead Sponsor
Pennington Biomedical Research Center
Brief 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.

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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
12
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
4mg 4 SprayDiltiazemStaff member will administer an atomizer (device that changes a liquid into a fine spray) that will go into both nostrils. The atomizer will contain diltiazem, RxC Use 4mg/4 spray Diltiazem
8mg 8 sprayDiltiazemStaff member will administer an atomizer (device that changes a liquid into a fine spray) that will go into both nostrils. The atomizer will contain diltiazem, RxC Use 8mg/8 spray Diltiazem
0mg 0 sprayPlacebo sprayNo Diltiazem
2mg 2 SprayDiltiazemStaff member will administer an atomizer (device that changes a liquid into a fine spray) that will go into both nostrils. The atomizer will contain diltiazem, RxC Use 2mg/2 spray Diltiazem
Primary Outcome Measures
NameTimeMethod
Evidence of blood pressure medication, diltiazem, will temporarily decrease the sense of smell when given in a nasal spray.3 weeks
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Pennington Biomedical Research Center

🇺🇸

Baton Rouge, Louisiana, United States

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