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

Primary Purpose

Male Infertility

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pomegranate juice
Sponsored by
POM Wonderful LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Male Infertility focused on measuring Male infertility

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Clinical Trials Program at University of California

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pomegranate juice

Arm Description

Pomegranate juice

Outcomes

Primary Outcome Measures

change in sperm counts
The primary outcome will be change in sperm counts relative to baseline with and without POM.

Secondary Outcome Measures

Change in Sperm count
The secondary outcome will be change in sperm counts relative to baseline with and without POM.

Full Information

First Posted
April 4, 2012
Last Updated
May 10, 2012
Sponsor
POM Wonderful LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01595308
Brief Title
A Pilot Study to Evaluate the Effect of Pomegranate Juice on Semen Parameters in Healthy Male Volunteers
Official Title
A Pilot Study to Evaluate the Effect of Pomegranate Juice on Semen Parameters in Healthy Male Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
POM Wonderful LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
How daily consumption of pomegranate juice affects the concentration, morphology or motility of sperm in healthy men.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Infertility
Keywords
Male infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pomegranate juice
Arm Type
Experimental
Arm Description
Pomegranate juice
Intervention Type
Dietary Supplement
Intervention Name(s)
Pomegranate juice
Intervention Description
Pomegranate juice
Primary Outcome Measure Information:
Title
change in sperm counts
Description
The primary outcome will be change in sperm counts relative to baseline with and without POM.
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
Change in Sperm count
Description
The secondary outcome will be change in sperm counts relative to baseline with and without POM.
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Rajfer, MD
Organizational Affiliation
Institute of Urologic Oncology at UCLA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Trials Program at University of California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States

12. IPD Sharing Statement

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

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