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

Common Cold Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00655031
• Other study ID #: A004
• Status: Completed
• Phase: Phase 2
• First received: April 4, 2008
• Last updated: August 14, 2008
• Start date: April 2008
• Est. completion date: July 2008

Study information

• Verified date: August 2008
• Source: POM Wonderful LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Nonsmoker

• No recent history of respiratory disease

Exclusion Criteria:

• Serum positive for rhinovirus

• Pregnant or breastfeeding

• Recent immunization

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Common Cold

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Virginia School of Medicine	Charlottesville	Virginia
United States	Accelovance Inc.	Huntsville	Alabama
United States	Accelovance Inc	Melbourne	Florida

Sponsors (1)

Lead Sponsor	Collaborator
POM Wonderful LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Comparison of symptom scores in the treatment groups		Days 1-5	No
Secondary	Determination of effects of treatment on immune function.		Days 1-5	No