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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:
Information provided by (Responsible Party):
POM Wonderful LLC
ClinicalTrials.gov Identifier:
NCT01595308
First received: April 4, 2012
Last updated: May 10, 2012
Last verified: May 2012
History of Changes
  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: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by POM Wonderful LLC:

Primary Outcome Measures:
  • change in sperm counts [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: POM Wonderful LLC
ClinicalTrials.gov Identifier: NCT01595308     History of Changes
Other Study ID Numbers: 2010-002
Study First Received: April 4, 2012
Last Updated: May 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by POM Wonderful LLC:
Male infertility

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

ClinicalTrials.gov processed this record on June 17, 2013