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NCT Number: NCT00655031

Trial to Evaluate the Use of Pomegranate Concentrate (POMx) for the Prevention of Experimental Rhinovirus Infection

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 reducing symptoms of common cold, reducing blood pressure, improving endothelial function, anti-tumor activity, and its anti-atherosclerotic activity. This study will evaluate the protective effect of a pomegranate concentrate (POMx) in decreasing the incidence and duration of the common cold among healthy adults.

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Key information

Conditions

Common Cold Infections Picornaviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Accelovance Inc., Huntsville, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Nonsmoker
  • No recent history of respiratory disease

Exclusion criteria

  • Serum positive for rhinovirus
  • Pregnant or breastfeeding
  • Recent immunization

Treatment and study plan

Pomegranate Concentrate (POMx)

Dietary Supplement

3.3 oz bottle containing antioxidants equivalent to 8 oz of pomegranate juice taken once daily for 7 days prior to infection and for 4 days after.

Placebo

Dietary Supplement

3.3 oz bottle containing fruit flavored juice low in antioxidants taken once daily for 7 days prior to infection and for 4 days after.

Primary outcomes

  1. The proportion of subjects who become infected in the active treatment group compared with the proportion of subjects who become infected in the placebo treatment group.

    Time frame: Days 1-5

Secondary outcomes

  1. Comparison of symptom scores in the treatment groups

    Time frame: Days 1-5

  2. Determination of effects of treatment on immune function.

    Time frame: Days 1-5

Sponsors and collaborators

Lead sponsor

POM Wonderful LLC

Industry

Registry information

Official study title

A Placebo Controlled, Randomized, Double Blind Pilot Study to Evaluate the Use of Pomegranate Concentrate (POMx) for the Prevention of Experimental Rhinovirus Infection in Human Subjects

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Apr 9, 2008
Registry last updated
Aug 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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