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A Pilot Study to Evaluate the Effect of Pomegranate Juice on Semen Parameters in Healthy Male Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01595308
First Posted: May 10, 2012
Last Update Posted: May 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
POM Wonderful LLC
  Purpose
How daily consumption of pomegranate juice affects the concentration, morphology or motility of sperm in healthy men.

Condition Intervention Phase
Male Infertility Dietary Supplement: Pomegranate juice Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate the Effect of Pomegranate Juice on Semen Parameters in Healthy Male Volunteers

Resource links provided by NLM:


Further study details as provided by POM Wonderful LLC:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Change in Sperm count [ Time Frame: 6 months ]
    The secondary outcome will be change in sperm counts relative to baseline with and without POM.


Enrollment: 12
Study Start Date: April 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pomegranate juice
Pomegranate juice
Dietary Supplement: Pomegranate juice
Pomegranate juice

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595308


Locations
United States, California
Clinical Trials Program at University of California
Los Angeles, California, United States, 90024
Sponsors and Collaborators
POM Wonderful LLC
Investigators
Principal Investigator: Jacob Rajfer, MD Institute of Urologic Oncology at UCLA
  More Information

Responsible Party: POM Wonderful LLC
ClinicalTrials.gov Identifier: NCT01595308     History of Changes
Other Study ID Numbers: 2010-002
First Submitted: April 4, 2012
First Posted: May 10, 2012
Last Update Posted: May 14, 2012
Last Verified: May 2012

Keywords provided by POM Wonderful LLC:
Male infertility

Additional relevant MeSH terms:
Infertility
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female