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

This study has been completed.
Sponsor:
Information provided by:
POM Wonderful LLC
ClinicalTrials.gov Identifier:
NCT00655031
First received: April 4, 2008
Last updated: August 14, 2008
Last verified: August 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


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
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by POM Wonderful LLC:
Punicaceae
Pomegranate

Additional relevant MeSH terms:
Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014