Pomegranate Products for Prevention of Common Cold
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00617318|
Recruitment Status : Completed
First Posted : February 18, 2008
Last Update Posted : February 18, 2008
|First Submitted Date ICMJE||February 6, 2008|
|First Posted Date ICMJE||February 18, 2008|
|Last Update Posted Date||February 18, 2008|
|Start Date ICMJE||January 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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. [ Time Frame: 16 weeks ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Pomegranate Products for Prevention of Common Cold|
|Official Title ICMJE||Pomegranate Products for Prevention of Common Cold and Influenza-Like Symptoms: A Double- Blind, Placebo-Controlled Randomized Clinical Trial|
|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.|
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 Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||June 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Subjects must meet all of the inclusion criteria in order to be eligible to participate in the study:
A subject meeting any of the exclusion criteria at baseline will be excluded from study participation:
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).
|Ages||21 Years to 49 Years (Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00617318|
|Other Study ID Numbers ICMJE||POM001|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Mohammad Madjid, Texas Heart Institute|
|Study Sponsor ICMJE||Texas Heart Institute|
|Collaborators ICMJE||POM Wonderful LLC|
|PRS Account||Texas Heart Institute|
|Verification Date||November 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP