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

POM Wonderful

Status and phase: Completed; Phase 2

Conditions: Common Cold

Treatments: Dietary Supplement: Pomegranate Concentrate (POMx); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00655031

A004

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Nonsmoker
• No recent history of respiratory disease

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Pomegranate concentrate (POMx)

Treatment:

Dietary Supplement: Pomegranate Concentrate (POMx)

2

Placebo Comparator group

Description:

Fruit flavored juice low in antioxidants

Treatment:

Dietary Supplement: Placebo