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Trial record 3 of 56 for:    linolenic acid

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

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ClinicalTrials.gov Identifier: NCT03040856
Recruitment Status : Recruiting
First Posted : February 2, 2017
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Aya Mohr-Sasson, Sheba Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Omega 3 Supplements During Pregnancy Dietary Supplement: Alpha Linolenic Acid Dietary Supplement: Omega 3 enriched diet ( DHA+EPA) Other: Placebo Not Applicable

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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. (


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040856


Contacts
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Contact: Aya Mohr Sasson, M.D +972-3-5302777 mohraya@gmail.com

Locations
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Israel
Dr. A Mohr-Sasson Recruiting
Ramat-Gan, Israel, 56506
Contact: Dr. A Mohr-Sasson    97235302777 ext 97235302777    mohraya@gmail.com   
Sponsors and Collaborators
Sheba Medical Center
Investigators
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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 of Results:

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Responsible Party: Dr. Aya Mohr-Sasson, Principal Investigator, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT03040856     History of Changes
Other Study ID Numbers: 3503-16-SMC
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Dr. Aya Mohr-Sasson, Sheba Medical Center:
Omega 3
Supplements
Alpha Linolenic Acid