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

Sponsored by:	POM Wonderful LLC
Information provided by:	POM Wonderful LLC
ClinicalTrials.gov Identifier:	NCT00655031

Purpose

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.

Condition	Intervention	Phase
Common Cold	Dietary Supplement: Pomegranate Concentrate (POMx) Dietary Supplement: Placebo	Phase II

MedlinePlus related topics: Common Cold Dietary Supplements Diets

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	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

Further study details as provided by POM Wonderful LLC:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparison of symptom scores in the treatment groups [ Time Frame: Days 1-5 ] [ Designated as safety issue: No ]
Determination of effects of treatment on immune function. [ Time Frame: Days 1-5 ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	April 2008
Study Completion Date:	July 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Placebo Comparator 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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Nonsmoker
No recent history of respiratory disease

Exclusion Criteria:

Serum positive for rhinovirus
Pregnant or breastfeeding
Recent immunization

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655031

Locations

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

Sponsors and Collaborators

POM Wonderful LLC

Investigators

Principal Investigator:

Ronald B Turner, MD

University of Virginia

More Information

No publications provided

Responsible Party:	POM Wonderful LLC ( Mark Dreher / Vice President, Scientific and Regulatory Affairs )
Study ID Numbers:	A004
Study First Received:	April 4, 2008
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00655031 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by POM Wonderful LLC:

Punicaceae
Pomegranate

Study placed in the following topic categories:

Virus Diseases
Antioxidants
Respiratory Tract Diseases

Respiratory Tract Infections
Common Cold
Picornaviridae Infections

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases

Respiratory Tract Infections
Common Cold
Picornaviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009