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

Male Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01595308
• Other study ID #: 2010-002
• Status: Completed
• Phase: Phase 1
• First received: April 4, 2012
• Last updated: May 10, 2012
• Start date: April 2011
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: POM Wonderful LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility

Intervention

Dietary Supplement:
• Pomegranate juice
Pomegranate juice

Locations

Country	Name	City	State
United States	Clinical Trials Program at University of California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
POM Wonderful LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in sperm counts	The primary outcome will be change in sperm counts relative to baseline with and without POM.	Baseline and 6 months	No
Secondary	Change in Sperm count	The secondary outcome will be change in sperm counts relative to baseline with and without POM.	6 months	No