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

Phase 1

Completed

• Conditions: Male Infertility
• Interventions: Dietary Supplement: Pomegranate juice

• Registration Number: NCT01595308
• Lead Sponsor: POM Wonderful LLC

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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2012-04-04
• Status Verified: 2012-05
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Study First Submitted QC: 2012-05-09
• Study First Posted: 2012-05-10
• Last Update Submitted: 2012-05-10
• Last Update Posted: 2012-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pomegranate juice	Pomegranate juice	Pomegranate juice

Primary Outcome Measures

Name	Time	Method
change in sperm counts	Baseline and 6 months	The primary outcome will be change in sperm counts relative to baseline with and without POM.

Secondary Outcome Measures

Name	Time	Method
Change in Sperm count	6 months	The secondary outcome will be change in sperm counts relative to baseline with and without POM.

Trial Locations

Locations (1)

Clinical Trials Program at University of California; 🇺🇸 Los Angeles, California, United States