Pomegranate Products for Prevention of Common Cold
Condition: Influenza; Common Cold; Cough; Headache; Fever
MeSH terms: Influenza, Human; Common Cold; Headache
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Pomegranate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Pomegranate; Influenza; Common Cold; Cough; Severity; Efficacy