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

August 14, 2008 updated by: POM Wonderful LLC

A Placebo Controlled, Randomized, Double Blind Pilot Study to Evaluate the Use of Pomegranate Concentrate (POMx) for the Prevention of Experimental Rhinovirus Infection in Human Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35802
        • Accelovance Inc.
    • Florida
      • Melbourne, Florida, United States, 32935
        • Accelovance Inc
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Nonsmoker
  • No recent history of respiratory disease

Exclusion Criteria:

  • Serum positive for rhinovirus
  • Pregnant or breastfeeding
  • Recent immunization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Pomegranate concentrate (POMx)
Dietary supplement: 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.
Placebo Comparator: 2
Fruit flavored juice low in antioxidants
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of subjects who become infected in the active treatment group compared with the proportion of subjects who become infected in the placebo treatment group.
Time Frame: Days 1-5
Days 1-5

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of symptom scores in the treatment groups
Time Frame: Days 1-5
Days 1-5
Determination of effects of treatment on immune function.
Time Frame: Days 1-5
Days 1-5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

POM Wonderful LLC

Investigators

  • Principal Investigator: Ronald B Turner, MD, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

April 4, 2008

First Submitted That Met QC Criteria

April 4, 2008

First Posted (Estimate)

April 9, 2008

Study Record Updates

Last Update Posted (Estimate)

August 18, 2008

Last Update Submitted That Met QC Criteria

August 14, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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