- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01595308
A Pilot Study to Evaluate the Effect of Pomegranate Juice on Semen Parameters in Healthy Male Volunteers
May 10, 2012 updated by: POM Wonderful LLC
How daily consumption of pomegranate juice affects the concentration, morphology or motility of sperm in healthy men.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To determine, in this pilot study, whether daily consumption of pomegranate juice (POM) affects the concentration, morphology or motility of sperm in healthy men.
The purpose of the present pilot study is to examine the hypothesis that POM may improve semen parameters in men.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90024
- Clinical Trials Program at University of California
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 12 healthy men aged 18-40
- normal sperm counts
Exclusion Criteria:
- History of undescended testes or surgery to the scrotal contents,
- History of marijuana or alcohol abuse, hot tub usage at least 3 months prior to entry into the study
- No alpha adrenergic medications within two weeks of entry into the study,
- No anabolic steroid use,
- No anticholinergic or antimuscarinic drugs, use of colchicine, cimetidine, sulfasalazine, antipsychotics, antidepressants, immunosuppressive drugs prior use of any chemotherapeutic drugs, or UTI on screening visit.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pomegranate juice
|
Pomegranate juice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in sperm counts
Time Frame: Baseline and 6 months
|
The primary outcome will be change in sperm counts relative to baseline with and without POM.
|
Baseline and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Sperm count
Time Frame: 6 months
|
The secondary outcome will be change in sperm counts relative to baseline with and without POM.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jacob Rajfer, MD, Institute of Urologic Oncology at UCLA
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
April 4, 2012
First Submitted That Met QC Criteria
May 9, 2012
First Posted (Estimate)
May 10, 2012
Study Record Updates
Last Update Posted (Estimate)
May 14, 2012
Last Update Submitted That Met QC Criteria
May 10, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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