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

Phase 2

Completed

• Conditions: Common Cold
• Interventions: Dietary Supplement: Pomegranate Concentrate (POMx); Dietary Supplement: Placebo

• Registration Number: NCT00655031
• Lead Sponsor: POM Wonderful LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-04
• Study First Submitted QC: 2008-04-04
• Study First Posted: 2008-04-09
• Primary Completion: 2008-05
• Study Completion: 2008-07
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-14
• Last Update Posted: 2008-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Nonsmoker
• No recent history of respiratory disease

Exclusion Criteria

• Serum positive for rhinovirus
• Pregnant or breastfeeding
• Recent immunization

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Pomegranate Concentrate (POMx)	Pomegranate concentrate (POMx)
2	Placebo	Fruit flavored juice low in antioxidants

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Comparison of symptom scores in the treatment groups	Days 1-5
Determination of effects of treatment on immune function.	Days 1-5

Trial Locations

Locations (3)

Accelovance Inc.; 🇺🇸 Huntsville, Alabama, United States

University of Virginia School of Medicine; 🇺🇸 Charlottesville, Virginia, United States

Accelovance Inc; 🇺🇸 Melbourne, Florida, United States