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

Overview

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.

Full Title of Study: “Human Milk Sample Collection From Israeli Mothers and Its Analysis and Correlation Between Composition, Demographics and Diet”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2017

Arms, Groups and Cohorts

  • Mothers for term infants
    • Lactating mothers
  • Mothers for preterm infants
    • Lactating mothers

Clinical Trial Outcome Measures

Primary Measures

  • Analysis of natural lipids in human breast milk of Israeli’s mothers
    • Time Frame: 30-60 days after delivery
    • exploratory study

Secondary Measures

  • Maternal diet survey
    • Time Frame: 30-60 days after delivery
    • exsploratory study

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 15 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Enzymotec
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yael Lifshitz, PhD, Study Director, Employee

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