Trial to Evaluate the Use of Pomegranate Concentrate (POMx) for the Prevention of Experimental Rhinovirus Infection
Primary Purpose
Common Cold
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pomegranate Concentrate (POMx)
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Common Cold focused on measuring Punicaceae, Pomegranate
Eligibility Criteria
Inclusion Criteria:
- Nonsmoker
- No recent history of respiratory disease
Exclusion Criteria:
- Serum positive for rhinovirus
- Pregnant or breastfeeding
- Recent immunization
Sites / Locations
- Accelovance Inc.
- Accelovance Inc
- University of Virginia School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Pomegranate concentrate (POMx)
Fruit flavored juice low in antioxidants
Outcomes
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.
Secondary Outcome Measures
Comparison of symptom scores in the treatment groups
Determination of effects of treatment on immune function.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00655031
Brief Title
Trial to Evaluate the Use of Pomegranate Concentrate (POMx) for the Prevention of Experimental Rhinovirus Infection
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
POM Wonderful LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold
Keywords
Punicaceae, Pomegranate
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Pomegranate concentrate (POMx)
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Fruit flavored juice low in antioxidants
Intervention Type
Dietary Supplement
Intervention Name(s)
Pomegranate Concentrate (POMx)
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Comparison of symptom scores in the treatment groups
Time Frame
Days 1-5
Title
Determination of effects of treatment on immune function.
Time Frame
Days 1-5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Nonsmoker
No recent history of respiratory disease
Exclusion Criteria:
Serum positive for rhinovirus
Pregnant or breastfeeding
Recent immunization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald B Turner, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Accelovance Inc.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35802
Country
United States
Facility Name
Accelovance Inc
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32935
Country
United States
Facility Name
University of Virginia School of Medicine
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Trial to Evaluate the Use of Pomegranate Concentrate (POMx) for the Prevention of Experimental Rhinovirus Infection
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