A Pilot Study to Evaluate the Effect of Pomegranate Juice... | NCT01595308

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

NCT01595308

Sponsor

POM Wonderful LLC

Status

Completed

Last Update Posted

May 14, 2012Estimated

Enrollment

12Actual

Phase

Phase 1

Conditions

Male Infertility

Interventions

Pomegranate juice

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

May 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Apr 4, 2012

First Submission Date that Met QC Criteria

May 9, 2012

First Posted Date

May 10, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2012

Last Update Posted Date

May 14, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pomegranate juice	Experimental	Pomegranate juice	Dietary Supplement: Pomegranate juice

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pomegranate juice	Dietary Supplement	Pomegranate juice	Pomegranate juice

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jacob Rajfer, MD	Institute of Urologic Oncology at UCLA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Trials Program at University of California		Los Angeles	California	90024	United States

Condition Browse Module

MeSH Terms

ID	Term
D007248	Infertility, Male

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007246	Infertility

Browse Leaves

Not provided

Browse Branches

Not provided