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

  • United States
    • 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
Dietary supplement: 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

POM Wonderful LLC

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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