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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- POM Wonderful LLC
- Enrollment
- 150
- Locations
- 3
- Primary Endpoint
- 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.
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Nonsmoker
- •No recent history of respiratory disease
Exclusion Criteria
- •Serum positive for rhinovirus
- •Pregnant or breastfeeding
- •Recent immunization
Arms & Interventions
1
Pomegranate concentrate (POMx)
Intervention: Pomegranate Concentrate (POMx) (Dietary Supplement)
2
Fruit flavored juice low in antioxidants
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
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
- Comparison of symptom scores in the treatment groups(Days 1-5)
- Determination of effects of treatment on immune function.(Days 1-5)