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

Sponsor
Sheba Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02925013
Collaborator
(none)
20
1
2
40
0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Blood sampling
  • Other: Dietary- Normal western diet
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Maternal Dietary Lipids and Omega 3 Essential Fatty Acids Profile in Pregnant Women at Term and Their Fetuses
Actual Study Start Date :
Jul 1, 2018
Actual Primary Completion Date :
Oct 30, 2021
Actual Study Completion Date :
Oct 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Omega 3 lipid profile in pregnant women at term [through study completion, an average of 1year]

  2. Omega 3 lipid profile in umbilical vein [through study completion, an average of 1year]

  3. Omega 3 lipid profile in women in fertility age [through study completion, an average of 1year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 42 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Pregnant women in labor( above 34 weeks of gestation )

  • Age:18-42

Exclusion Criteria:
  • taking any kind of dietary supplementation

  • hyperlipidemia / hypercholesterolemia

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sheba Medical Center Ramat Gan Israel

Sponsors and Collaborators

  • Sheba Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dr. Aya Mohr-Sasson, Principal Investigator, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT02925013
Other Study ID Numbers:
  • 9649-12
First Posted:
Oct 5, 2016
Last Update Posted:
Nov 11, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Aya Mohr-Sasson, Principal Investigator, Sheba Medical Center

Study Results

No Results Posted as of Nov 11, 2021