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Sponsored by: |
POM Wonderful LLC |
Information provided by: | POM Wonderful LLC |
ClinicalTrials.gov Identifier: | NCT00655031 |
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 |
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 |
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)
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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.
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2: Placebo Comparator
Fruit flavored juice low in antioxidants
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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.
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
POM Wonderful LLC |
Principal Investigator: | Ronald B Turner, MD | University of Virginia |
Responsible Party: | POM Wonderful LLC ( Mark Dreher / Vice President, Scientific and Regulatory Affairs ) |
Study ID Numbers: | A004 |
First Received: | April 4, 2008 |
Last Updated: | August 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00655031 |
Health Authority: | United States: Institutional Review Board |
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