Pomegranate Products for Prevention of Common Cold

NCT00617318 | Completed Phase 3 DMC

• 1 other identifier: POM001
• Study Type: interventional
• Target: 461
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza; Common Cold; Cough; Headache; Fever

Keywords

Pomegranate; Influenza; Common Cold; Cough; Severity; Efficacy

Outcome Measures

Primary Outcomes (1)

• 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.

  16 weeks

Study Arms (2)

A

EXPERIMENTAL

Dietary Supplement: Pomegranate

B

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Pomegranate DIETARY_SUPPLEMENT

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.

A

Placebo DIETARY_SUPPLEMENT

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.

B

Eligibility Criteria

• Age: 21 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject must be able to read and sign Informed Consent Form (ICF).
• Subject must be male or female \> 21 and \< 49 years of age at the time the ICF is signed.
• Subject must have made a personal decision NOT to receive influenza vaccine this season.

You may not qualify if:

• Subject who has a known allergy to pomegranate and POM products. Subject who has an intercurrent infection and fever during the week before the investigational product administration is to begin.
• 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).
• Subject who reports HIV infection.
• Subject who abuses alcohol or other drugs of abuse.
• Subject who has clinical evidence of current malignancy.
• Female subject with positive pregnancy test, or who is sexually active and not using adequate contraception regularly, or who is a nursing mother.
• Subject who has taken other experimental products within one month prior to study entry.
• Subject who has any medical condition that may interfere with study protocol adherence.
• Subject has any disorder (excluding illiteracy or visual impairment) that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
• Subject who in the opinion of the study investigator has a risk of non-compliance with study procedures, or cannot read, understand or complete study related materials.
• Subject who has a foreseeable inability to complete the scheduled follow-ups.
• Subject who meets one or more of the criteria for influenza immunization according to the current CDC List of Priority Groups for Vaccination.

Sponsors & Collaborators

• Texas Heart Institute: lead
• POM Wonderful LLC: collaborator

Study Sites (1)

Site 01

San Diego, California, 92108, United States

Location

MeSH Terms

Conditions

Influenza, Human; Common Cold; Cough; Headache; Fever

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Picornaviridae Infections; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Body Temperature Changes

Study Officials

• Mohammad Madjid, MD

  Texas Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 6, 2008
• First Posted: February 18, 2008
• Study Start: January 1, 2007
• Study Completion: June 1, 2007
• Last Updated: February 18, 2008

Record last verified: 2007-11

Locations

US (1)