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Pomegranate Products for Prevention of Common Cold

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00617318
Enrollment
461
Registered
2008-02-18
Start date
2007-01-31
Completion date
2007-06-30
Last updated
2008-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Common Cold, Cough, Fever, Headache, Influenza

Keywords

Pomegranate, Influenza, Common Cold, Cough, Severity, Efficacy

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 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.

Detailed 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.

Interventions

DIETARY_SUPPLEMENTPomegranate

All subjects were randomized and assigned to a 16-week treatment with either POM concentrate or placebo. The placebo matched the taste, smell, and appearance of the POM concentrate. Supplies were shipped to the investigation site in equal proportions marked as A and B, and site personnel did not know the code. The treatment products (POM concentrate or placebo) were supplied as 2-oz packages, each containing a single day's consumption, and were dispensed as packages of 33 units (a 4-week plus 5-day supply). The subjects were to consume one 2 oz. package daily for a period of 16 weeks.

DIETARY_SUPPLEMENTPlacebo

All subjects were randomized and assigned to a 16-week treatment with either POM concentrate or placebo. The placebo matched the taste, smell, and appearance of the POM concentrate. Supplies were shipped to the investigation site in equal proportions marked as A and B, and site personnel did not know the code. The treatment products (POM concentrate or placebo) were supplied as 2-oz packages, each containing a single day's consumption, and were dispensed as packages of 33 units (a 4-week plus 5-day supply). The subjects were to consume one 2 oz. package daily for a period of 16 weeks.

Sponsors

POM Wonderful LLC
CollaboratorINDUSTRY
Texas Heart Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
21 Years to 49 Years
Healthy volunteers
Yes

Inclusion criteria

Subjects must meet all of the inclusion criteria in order to be eligible to participate in the study: * Subject must be able to read and sign Informed Consent Form (ICF). * Subject must be male or female \> 21 and \< 49 years of age at the time the ICF is signed. * Subject must have made a personal decision NOT to receive influenza vaccine this season.

Exclusion criteria

A subject meeting any of the

Design outcomes

Primary

MeasureTime frame
The primary outcome measure will be the incidence and severity of common cold using the modified severity scoring system during the sixteen week period of the POM Flu and Cold Formula use.16 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026