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

Pennington Biomedical Research Center

Status and phase: Terminated; Phase 1

Conditions: Food Intake

Treatments: Drug: Diltiazem; Other: Placebo spray

Study type: Interventional

Funder types: Other

Identifiers

NCT01021176

PBRC 27016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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12 participants in 4 patient groups, including a placebo group

0mg 0 spray

Placebo Comparator group

Description:

No Diltiazem

Treatment:

Other: Placebo spray

2mg 2 Spray

Active Comparator group

Description:

Staff 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

Treatment:

Drug: Diltiazem

4mg 4 Spray

Active Comparator group

Description:

Staff 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

Treatment:

Drug: Diltiazem

8mg 8 spray

Active Comparator group

Description:

Staff 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

Treatment:

Drug: Diltiazem