Human Milk Sample Composition in Israeli Mothers and Correlation With Their Diet

Human Milk Sample Collection From Israeli Mothers and Its Analysis and Correlation Between Composition, Demographics and Diet

The study will collect human milk from 100 mother of term infants 2-3m after delivery and from 50 mothers of preterm infants 14 and 30 days after delivery. Sample content will be analysed and statistical analysis will look at correlation between demographics, dietary habits and milk composition.

Study Overview

• Status: Completed
• Conditions: Breast Milk Collection

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Israel
  • State
    • Kfar Saba, State, Israel, 340000
      • Meir Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

General healthy lactating mothers

Description

Inclusion Criteria:

Generally healthy mothers who give birth to a healthy term infant (37-42 weeks) Mothers who intend to breastfeed the infant at least 80% of the daily feeding Mothers who can comply with the study requirements Mothers who sign the informed consent form in writing and can read and write Hebrew.

Exclusion Criteria:

• Participation in any other studies involving investigational or marketed products Is consuming alcoholic drinks and is a drug abuser. Is suffering from chronic disease Presence of psychosis and severe post-partum depression. Mothers who have given birth to twins or multiples Mothers who received chemotherapy or isotopes during pregnancy investigator's uncertainty about the willingness or ability of the mothers to understand and comply with the protocol requirements.

Infants:

Any congenital abnormality, chromosomal disorder or severe disease which could interfere with the study conduct and assessment.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Mothers for term infants; Lactating mothers
Mothers for preterm infants; Lactating mothers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of natural lipids in human breast milk of Israeli's mothers	exploratory study	30-60 days after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal diet survey	exsploratory study	30-60 days after delivery

Collaborators and Investigators

• Sponsor: Enzymotec
• Investigators: Study Director: Yael Lifshitz, PhD, Employee

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: November 3, 2015
• First Submitted That Met QC Criteria: November 3, 2015
• First Posted (Estimate): November 4, 2015

Study Record Updates

• Last Update Posted (Actual): February 5, 2018
• Last Update Submitted That Met QC Criteria: February 1, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: HM001