InfluenzaPhase 3NCT00617318
Pomegranate Products for Prevention of Common Cold
A Phase 3 study testing Pomegranate in people with Influenza and Common Cold, run by Texas Heart Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Common Cold, Cough
- What is being tested?
- Pomegranate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 461 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jun 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must meet all of the inclusion criteria in order to be eligible to participate in the study:
- 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.
Who cannot join
- A subject meeting any of the exclusion criteria at baseline will be excluded from study participation:
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pomegranate Products for Prevention of Common Cold and Influenza-Like Symptoms: A Double- Blind, Placebo-Controlled Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Influenza, Common Cold, Cough, Headache, Fever
- Being tested
- Pomegranate, Placebo
- Keywords
- Pomegranate, Influenza, Common Cold, Cough, Severity, Efficacy
- Medical subject headings
- Influenza, Human, Common Cold, Cough, Headache, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PomegranateDietary 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.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Dietary Supplement: Pomegranate |
| B | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2008 (estimated)
- Study startJan 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 461 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- POM Wonderful LLC
- Investigators
- Mohammad Madjid, MD, Principal investigator, Texas Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617318
- Sponsor's protocol ID
- POM001
- Status last verified
- Nov 2007
- First submitted
- 6 Feb 2008
- Last updated
- 18 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pomegranate Products for Prevention of Common Cold and Influenza-Like Symptoms: A Double- Blind, Placebo-Controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00617318
- Acronym / sponsor ID
- POM001
- Conditions
- Influenza, Common Cold, Cough, Headache, Fever
- Keywords
- Pomegranate, Influenza, Common Cold, Cough, Severity, Efficacy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 461 participants (actual)
- Lead sponsor
- Texas Heart InstituteUniversity, hospital or other
- Collaborators
- POM Wonderful LLC
- Study start
- Jan 2007
- Study completion
- Jun 2007 (actual)
- First posted
- 18 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Dietary Supplement: Pomegranate |
| B | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 21 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects must meet all of the inclusion criteria in order to be eligible to participate in the study:
- 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.
Key exclusion criteria (14 listed)
- A subject meeting any of the exclusion criteria at baseline will be excluded from study participation:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PomegranateAll 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. | Dietary supplement | A |
| PlaceboAll 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. | Dietary supplement | B |
Primary outcome
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.
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Madjid, MD principal investigator
Texas Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pomegranate in people with Influenza and Common Cold, run by Texas Heart Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2008; AzTrials last refreshed its copy on 7 Nov 2026.