Trial to Evaluate the Use of Pomegranate Concentrate (POMx) for the Prevention of Experimental Rhinovirus Infection
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
1 other identifier
interventional
150
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2008
Shorter than P25 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 4, 2008
CompletedFirst Posted
Study publicly available on registry
April 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedAugust 18, 2008
August 1, 2008
1 month
April 4, 2008
August 14, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Days 1-5
Secondary Outcomes (2)
Comparison of symptom scores in the treatment groups
Days 1-5
Determination of effects of treatment on immune function.
Days 1-5
Study Arms (2)
1
EXPERIMENTALPomegranate concentrate (POMx)
2
PLACEBO COMPARATORFruit flavored juice low in antioxidants
Interventions
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.
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 Criteria
You may qualify if:
- Nonsmoker
- No recent history of respiratory disease
You may not qualify if:
- Serum positive for rhinovirus
- Pregnant or breastfeeding
- Recent immunization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Accelovance Inc.
Huntsville, Alabama, 35802, United States
Accelovance Inc
Melbourne, Florida, 32935, United States
University of Virginia School of Medicine
Charlottesville, Virginia, 22908, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald B Turner, MD
University of Virginia
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 4, 2008
First Posted
April 9, 2008
Study Start
April 1, 2008
Primary Completion
May 1, 2008
Study Completion
July 1, 2008
Last Updated
August 18, 2008
Record last verified: 2008-08