NCT01800110

Brief Summary

Many medicinal effects of Pomegranate juices are already known. Mainly known for its anti-viral, anti-bacterial and anti-oxide tendency of pomegranate juice. Many studies which have demonstrated antioxidant activity of pomegranate juice in the blood and blood cells were published. In addition, published studies have demonstrated the anti-oxidant activity which inhibit the development of atherosclerosis and stroke, even in patients with diabetes, and its effect of decreasing systolic blood pressure in patients with systemic hypertension. The purpose of the work is to examine the effect of drinking pomegranate juice on the level of anti-oxidants in human breast milk.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 27, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Last Updated

February 27, 2013

Status Verified

February 1, 2013

Enrollment Period

2 years

First QC Date

February 19, 2013

Last Update Submit

February 25, 2013

Conditions

Breast Milk

Outcome Measures

Primary Outcomes (1)

  • anti oxidant level in human breast milk

    at least one year

Study Arms (1)

2

EXPERIMENTAL

label I- 200 cc pomegranate juice once daily for 6 weeks post partum. label II- control group, no placebo is givening.

Dietary Supplement: pomegranate juice

Interventions

pomegranate juiceDIETARY_SUPPLEMENT
2

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • lactating woman

You may not qualify if:

  • pomegranate allergy
  • diabetes mellitus
  • use of other Dietary Supplement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2013

First Posted

February 27, 2013

Study Start

April 1, 2013

Primary Completion

April 1, 2015

Last Updated

February 27, 2013

Record last verified: 2013-02