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

Study Overview
=================
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.

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

Conditions
-----------------
Common Cold

Intervention / Treatment
-----------------
* Dietary Supplement: Pomegranate Concentrate (POMx)
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nonsmoker No recent history of respiratory disease Exclusion Criteria: Serum positive for rhinovirus Pregnant or breastfeeding Recent immunization

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Pomegranate concentrate (POMx) | Dietary Supplement: Pomegranate Concentrate (POMx)<br>* 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.<br>|
| Placebo Comparator: 2<br>Fruit flavored juice low in antioxidants | Dietary Supplement: Placebo<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of symptom scores in the treatment groups |  | Days 1-5 | 
| Determination of effects of treatment on immune function. |  | Days 1-5 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Punicaceae, Pomegranate