Pomegranate Products for Prevention of Common Cold and Influenza-Like Symptoms: A Double- Blind, Placebo-Controlled Randomized Clinical Trial
21 Years
49 Years
Both
Influenza, Common Cold, Cough, Headache, Fever
Trial Information
Pomegranate Products for Prevention of Common Cold and Influenza-Like Symptoms: A Double- Blind, Placebo-Controlled Randomized Clinical Trial
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.
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 exclusion criteria at baseline will be excluded from study
participation:
- Subject who has a known allergy to pomegranate and POM products. Subject who has an
intercurrent infection and fever during the week before the investigational product
administration is to begin.
Subject who has experienced acute respiratory tract infection, otitis media, bronchitis or
sinusitis, or who had been treated with an antiviral drug, systemic steroids, or
immunosuppressants within two weeks of the Screening/Randomization Visit.
Subject who has uncontrolled chronic medical disorders (e.g., subjects with evidence of
evolving hepatic or renal failure, congestive heart failure Killip Class IV, or any
terminal disease).
- Subject who reports HIV infection.
- Subject who abuses alcohol or other drugs of abuse.
- Subject who has clinical evidence of current malignancy.
- Female subject with positive pregnancy test, or who is sexually active and not using
adequate contraception regularly, or who is a nursing mother.
- Subject who has taken other experimental products within one month prior to study
entry.
- Subject who has any medical condition that may interfere with study protocol
adherence.
- Subject has any disorder (excluding illiteracy or visual impairment) that compromises
the ability of the subject to give written informed consent and/or to comply with
study procedures.
- Subject who in the opinion of the study investigator has a risk of non-compliance
with study procedures, or cannot read, understand or complete study related
materials.
- Subject who has a foreseeable inability to complete the scheduled follow-ups.
- Subject who meets one or more of the criteria for influenza immunization according to
the current CDC List of Priority Groups for Vaccination.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Outcome Measure:
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.
Outcome Time Frame:
16 weeks
Safety Issue:
Yes
Principal Investigator
Mohammad Madjid, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Texas Heart Institute
Authority:
United States: Institutional Review Board
Study ID:
POM001
NCT ID:
NCT00617318
Start Date:
January 2007
Completion Date:
June 2007
Related Keywords:
- Influenza
- Common Cold
- Cough
- Headache
- Fever
- Pomegranate
- Influenza
- Common Cold
- Cough
- Severity
- Efficacy
- Common Cold
- Cough
- Headache
- Influenza, Human
Name | Location |
|---|---|
| Site 01 | San Diego, California 92108 |
