Maternal Dietary Lipids and Omega 3 Essential Fatty Acids Profile in Pregnant Women at Term and Their Fetuses (OM3)

November 4, 2021 updated by: Dr. Aya Mohr-Sasson, Sheba Medical Center
This study aims to investigate the omega 3 lipid profile in pregnant women at term and their fetuses compared to non pregnant women , in normal western diet adding no supplementation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

DHA (Docosahexaenoic Acid ) is a long chain omega-3 fatty acid important for brain and eye development and function throughout life. It also supports heart health. DHA is the most abundant omega-3 in the brain and retina and is naturally found in breast milk. EPA (Eicosapentaenoic Acid ) is a long-chain omega-3 fatty acid important for overall health. However, unlike DHA, the body does not store EPA in significant quantities in the brain or retina (DHA is found in every cell throughout the body, EPA is not). These Omega 3 fatty acids are considered essential due to the inability of the human body to create them and the need to consume them from nutritional source. Food that is considered rich in omega 3 fatty acids are fat fish and green vegetables. Omega-3 fatty acids are "good fats," and are among the most important nutrients lacking in Western diets today. The average person in developed countries consumes less than 100 mg of DHA daily. With increasing awareness of the importance of DHA, many people realize that they need to make a change to their diet by adding DHA-rich foods or supplements.

Alpha Linolenic Acid (ALA) is a shorter-chain omega-3 that serves as a source of energy and as a building block for long-chain omega-3 fatty acids (DHA and EPA). This precursor for omega 3 fatty acid is abundant in falx seeds. The mother and the fetus has the metabolic mechanism that enables them to transform ALA into EPA,DHA endogenously.

Women during pregnancy are predisposed to a reduction in unsaturated long chain fatty acid (polyunsaturated Fatty Acid = PUFA) from the omega 3 group . Lately, a new hypothesis claiming that a reduced level of this essential acids expose the fetus later in his adult life to a spectrum of metabolic and cardiovascular disease. New publication on animal models showed higher rates of obesity, insulin resistance diabetes and cardiovascular damage on mice exposed short chain fatty acids compared to those treated with enriched ALA diet supplementation. Different nutritional and gynecological health organization around the world including the FDA, recommend incorporating omega 3 fatty acids supplementation to daily diet and specifically in pregnant women in order to raise their blood levels for the developing fetus. However, normal fatty acid profile of the omega 3 group in mother and fetus haven't been described yet . Furthermore, the total effect and future benefit to fetus haven't been thoroughly studied and is based mainly on presumptions.

The aim of this study is to learn the typical omega 3 fatty acid profile at women near delivery and their fetuses and to compare it to women in productive years that are not pregnant.

Study methods:

Women close to term visiting the obstetrical triage and fitting inclusion criteria will be offered to participate in the study. Demographic medical and obstetrical information will be collected from medical files after giving signed informed consent .

Blood sample ( one blood tube that will include 5 cc of blood ) will be taken while insertion of intravenous line in the delivery room, and another blood sample will be taken from the umbilical vein after delivery and separation of the fetus from the umbilical cord.

Women for control group - healthy non pregnant women in fertility years, will be recruited from the gynecological clinic . Similarly to the study group, one of the study researchers will collect one tube for blood sampling ( equal to 5 cc of blood ).

All samples will be sent for profile analysis of omega 3 fatty acids.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat Gan, Israel
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant women in labor( above 34 weeks of gestation )
  • Age:18-42

Exclusion Criteria:

  • taking any kind of dietary supplementation
  • hyperlipidemia / hypercholesterolemia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Pregnant women at delivery
Procedure: Blood sampling
Blood sampling for lipid profile
Other: Dietary- Normal western diet
Normal western diet
Other: Control group
Women in fertility age not pregnant
Procedure: Blood sampling
Blood sampling for lipid profile
Other: Dietary- Normal western diet
Normal western diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Omega 3 lipid profile in pregnant women at term
Time Frame: through study completion, an average of 1year
through study completion, an average of 1year
Omega 3 lipid profile in umbilical vein
Time Frame: through study completion, an average of 1year
through study completion, an average of 1year
Omega 3 lipid profile in women in fertility age
Time Frame: through study completion, an average of 1year
through study completion, an average of 1year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Actual)

October 30, 2021

Study Completion (Actual)

October 30, 2021

Study Registration Dates

First Submitted

September 27, 2016

First Submitted That Met QC Criteria

October 4, 2016

First Posted (Estimate)

October 5, 2016

Study Record Updates

Last Update Posted (Actual)

November 11, 2021

Last Update Submitted That Met QC Criteria

November 4, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 9649-12

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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