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Trial to Evaluate the Use of Pomegranate Concentrate (POMx) for the Prevention of Experimental Rhinovirus Infection

NCT ID: NCT00655031

Last Updated: 2008-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-07-31

Brief Summary

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Pomegranate has a long history of use in folk medicine. There is vast data on the health benefits of pomegranate fruit and juice. Multiple studies have established the strong antioxidative effects of pomegranate polyphenols (primarily the ellagitannin punicalagin) and their health effects. A vast number of animal and human clinical studies have provided evidence on effect of pomegranate products on reducing symptoms of common cold, reducing blood pressure, improving endothelial function, anti-tumor activity, and its anti-atherosclerotic activity. This study will evaluate the protective effect of a pomegranate concentrate (POMx) in decreasing the incidence and duration of the common cold among healthy adults.

Detailed Description

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Conditions

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Common Cold

Keywords

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Punicaceae Pomegranate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Pomegranate concentrate (POMx)

Group Type EXPERIMENTAL

Pomegranate Concentrate (POMx)

Intervention Type DIETARY_SUPPLEMENT

3.3 oz bottle containing antioxidants equivalent to 8 oz of pomegranate juice taken once daily for 7 days prior to infection and for 4 days after.

2

Fruit flavored juice low in antioxidants

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

3.3 oz bottle containing fruit flavored juice low in antioxidants taken once daily for 7 days prior to infection and for 4 days after.

Interventions

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Pomegranate Concentrate (POMx)

3.3 oz bottle containing antioxidants equivalent to 8 oz of pomegranate juice taken once daily for 7 days prior to infection and for 4 days after.

Intervention Type DIETARY_SUPPLEMENT

Placebo

3.3 oz bottle containing fruit flavored juice low in antioxidants taken once daily for 7 days prior to infection and for 4 days after.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Nonsmoker
* No recent history of respiratory disease

Exclusion Criteria

* Serum positive for rhinovirus
* Pregnant or breastfeeding
* Recent immunization
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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POM Wonderful LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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POM Wonderful LLC

Principal Investigators

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Ronald B Turner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

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Accelovance Inc.

Huntsville, Alabama, United States

Site Status

Accelovance Inc

Melbourne, Florida, United States

Site Status

University of Virginia School of Medicine

Charlottesville, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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A004

Identifier Type: -

Identifier Source: org_study_id