Breast MilkNCT01800110
Influence of Pomegranate Juice Consumption on the Level of Antioxidants in Breast Milk
A study testing pomegranate juice in people with Breast Milk, run by Hillel Yaffe Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Milk
- What is being tested?
- pomegranate juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- lactating woman
Who cannot join
- pomegranate allergy
- diabetes mellitus
- use of other Dietary Supplement
About this study
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.
Read the detailed description
the effect of pomegranate juice consumption on breast milk anti oxidants level.
- Conditions
- Breast Milk
- Being tested
- pomegranate juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pomegranate juiceDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | label I- 200 cc pomegranate juice once daily for 6 weeks post partum. label II- control group, no placebo is givening. Receives: Dietary Supplement: pomegranate juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
anti oxidant level in human breast milk
Measured: at least one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast MilkStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800110
- Sponsor's protocol ID
- 0013-13
- Status last verified
- Feb 2013
- First submitted
- 19 Feb 2013
- Last updated
- 27 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Pomegranate Juice Consumption on the Level of Antioxidants in Breast Milk
- ClinicalTrials.gov ID
- NCT01800110
- Acronym / sponsor ID
- 0013-13
- Conditions
- Breast Milk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Apr 2013
- Primary completion
- Apr 2015 (estimated)
- First posted
- 27 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
the effect of pomegranate juice consumption on breast milk anti oxidants level.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Dietary Supplement: pomegranate juicelabel I- 200 cc pomegranate juice once daily for 6 weeks post partum. label II- control group, no placebo is givening. |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- lactating woman
Key exclusion criteria (3 listed)
- pomegranate allergy
- diabetes mellitus
- use of other Dietary Supplement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pomegranate juice | Dietary supplement | 2 |
Primary outcome
anti oxidant level in human breast milk
Time frame: at least one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing pomegranate juice in people with Breast Milk, run by Hillel Yaffe Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anti oxidant level in human breast milk (time frame: at least one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2013.