Pomegranate Products for Prevention of Common Cold

Influenza Clinical Trial

Official title: Pomegranate Products for Prevention of Common Cold and Influenza-Like Symptoms: A Double- Blind, Placebo-Controlled Randomized Clinical Trial

Status Completed

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 improving blood lipid profile, reducing blood pressure, improving endothelial function, anti-tumor activity, and its anti-atherosclerotic activity. We studied the protective effect of a pomegranate concentrate (POM Flu and Cold Formula®) in decreasing the incidence and duration of influenza-like illnesses and common cold among healthy adults.

Clinical Trial Description

Pomegranate has a long history of use in folk medicine. Widely grown and consumed in most countries, pomegranate fruit and its products are now being produced and used more extensively in the US. The health benefits of pomegranate fruit and juice have been substantiated by much research, including multiple studies that have shown the beneficial antioxidative effects of pomegranate polyphenols (primarily ellagitannin punicalagin). Both in vitro and in vivo studies have demonstrated that pomegranate products provide hepatoprotection against toxins, reduce tumor cell growth, and have anti-angiogenesis, immunomodulatory, and free-radical scavenging effects. Furthermore, both animal and clinical studies indicate that pomegranate products can improve the blood lipid profile, reduce blood pressure, enhance endothelial function, and provide anti-tumor and anti-atherosclerotic activities.

No adverse events have been reported in clinical studies of more than 300 human subjects who consumed 8 fluid ounces (oz) or more of POM Wonderful® (POM LLC, Los Angeles, CA) pomegranate juice daily for periods as long as 3 years. These clinical trials have included sensitive subpopulations, such as patients with atherosclerotic disease, diabetes, hypertension, or prostate cancer. Moreover, no serious adverse effects have been reported in human, animal and in vitro studies published to date.

Ex vivo laboratory studies have shown that pomegranate polyphenols have considerable antioxidant activity. Because of the importance of oxidative stress in influenza infection and its complications, we previously assessed the anti-influenza effects of pomegranate products in ex vivo studies (See accompanying manuscript). Our laboratory findings showing the anti-influenza, virucidal effects of pomegranate products led us to study their clinical effects against influenza and the common cold in human volunteers. Previous studies have shown the effects of natural products on the incidence and course of influenza infection.

The purpose of the current study was to assess the effect of a pomegranate concentrate (POM Flu and Cold Formula, POM Wonderful LLC, Los Angeles, CA) in preventing the symptoms of influenza and common cold during the influenza season. POM Flu and Cold Formula is intended for oral use to provide supplemental antioxidants to a healthy population. ;

Study Design

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

Related Conditions & MeSH terms

• Common Cold
• Cough
• Fever
• Headache
• Influenza
• Influenza, Human

• NCT number: NCT00617318
• Study type: Interventional
• Source: Texas Heart Institute
• Status: Completed
• Phase: Phase 3
• Start date: January 2007
• Completion date: June 2007