The Effect of Alpha Linolenic Acid (ALA) Supplementation During Pregnancy

April 6, 2022 updated by: Dr. Aya Mohr-Sasson, Sheba Medical Center

The Effect of Alpha Linolenic Acid (ALA) Supplementation on Essential Fatty Acids Profile During Pregnancy Compared to Common Supplements and the Epigenetic Effect on the Newborn

Omega-3 fatty acids are "good fats," and are among the most important nutrients lacking in Western diets today. The average person in developing 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 in their diet by adding DHA-rich foods or supplements.

The aim of this study is to learn the effect of different supplementations from the omega 3 group on the maternal and fetal fatty acid profile during pregnancy and to study their epigenetic influence.

Study Overview

Status

Withdrawn

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 developing 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 in 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 effect of different supplementations from the omega 3 group on the maternal and fetal fatty acid profile during pregnancy and to study their epigenetic influence.

Study methods:

Women 12 weeks of gestation visiting high risk unit 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 .

Each participant will be randomly assigned to one of three arms of the study based on the order of being recruited (1- to first group, 2- to second group, 3 - to third group, 4- to first group, etc.). Randomization will be done by the principal investigator that is not one of the high risk unit team, and will be blinded to the participants and the treating doctor.

Group 1: Enriched diet with 2 capsules of ALA supplementation a day - 630 mg in each capsule. Total amount of 1260 mg (Daily recommended dose is 1-2 g).

Group 2: Enriched diet with 2 capsules of DHA+EPA supplementation a day (Each capsule consist of 240 mg DHA and 360 mg EPA) Group 3: Control group - Will receive 2 placebo capsule a day (All products will be supplied by the same company that is approved by the FDA and the Israeli health ministry) Follow up will take place on every visit to the high risk unit that is 3 and 2 weeks apart at the second and third trimester, respectively. On each visit one blood tube that include 5cc of blood will be taken for fatty acid profile analysis and on labor 2 blood tubes will be taken from the mother and from the umbilical cord after separation of the placenta : 1- for fatty acid analysis , 2- for PCR evaluation of mRNAs of genes that were found correlated in animal models to be influenced by maternal diet during pregnancy and are connected to metabolic syndrome pathologies in adulthood ( including - FASn, Elov6, PPAR (α, β/δ, γ), SCD1, Fads2, SREBP-1 Ppargc1alpha, Lpin1, Plin5 , MAPK/PGC-1α. (

Study Type

Interventional

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, 56506
        • Dr. A Mohr-Sasson

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

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age 18-42
  • Singleton
  • Gestational age 12-16 during first visit at the high risk unit

Exclusion Criteria:

  • Liver Disease
  • Dyslipidemia
  • Twins
  • Warfarin, LMWH, Heparin use ( Due to suspected drug interaction that has been reported however has not been proven yet)

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alpha Linolenic Acid enriched diet
Enriched diet with 2 capsules of ALA supplementation a day - 630 mg in each capsule. Total amount of 1260 mg (Daily recommended dose is 1-2 g).
Dietary supplement: Alpha Linolenic Acid
Alpha Linolenic Acid enriched diet
Experimental: Omega 3 enriched diet ( DHA+EPA)
Enriched diet with 2 capsules of DHA+EPA supplementation a day (Each capsule consist of 240 mg DHA and 360 mg EPA).
Dietary supplement: Omega 3 enriched diet ( DHA+EPA)
Omega 3 (DHA+EPA) supplementation enriched diet
Placebo Comparator: Placebo
Control group - Will receive 2 placebo capsule a day - containing olive oil
Other: Placebo
Placebo capsules containing olive oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levels of Omega 3 fatty acids ( DHA, EPA, ALA)
Time Frame: Change in maternal levels of Omega 3 fatty acids ( DHA, EPA, ALA) from recruitment (12 week of gestation ) until delivery .
Change in Omega 3 fatty acids ( DHA, EPA, ALA) blood levels during different gestational weeks of pregnancy until delivery, including umbilical cord blood levels after the separation of the placenta ( third stage of delivery).
Change in maternal levels of Omega 3 fatty acids ( DHA, EPA, ALA) from recruitment (12 week of gestation ) until delivery .

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expression of messenger RNAs ( mRNAs) between the study groups
Time Frame: At delivery - Immediately after separation of the placenta ( Blood sample from the mother and from the umbilical cord)
Change between study groups in expression of mRNAs in the mother at delivery and in the fetus ( analyzing umbilical cord blood after separation of the placenta) ( including - FASn, Elov6, PPAR (α, β/δ, γ), SCD1, Fads2, SREBP-1 Ppargc1alpha, Lpin1, Plin5 , MAPK/PGC-1α)
At delivery - Immediately after separation of the placenta ( Blood sample from the mother and from the umbilical cord)

Collaborators and Investigators

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

Sponsor

Sheba Medical Center

Investigators

  • Study Director: Israel Hendler, M.D, Department of Obstetrics and Gynecology ,Sheba Medical Center, Ramat Gan, Israel
  • Study Director: Alicia Leikin-Frenkel, M.D, Ph.d, Bert Strassburger Lipid Center, Sheba Medical Center, Ramat Gan, Israel

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 (Anticipated)

February 1, 2022

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

February 1, 2017

First Submitted That Met QC Criteria

February 1, 2017

First Posted (Estimate)

February 2, 2017

Study Record Updates

Last Update Posted (Actual)

April 14, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3503-16-SMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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