<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03040856</url>
  </required_header>
  <id_info>
    <org_study_id>3503-16-SMC</org_study_id>
    <nct_id>NCT03040856</nct_id>
  </id_info>
  <brief_title>The Effect of Alpha Linolenic Acid (ALA) Supplementation During Pregnancy</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheba Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Omega-3 fatty acids are &quot;good fats,&quot; and are among the most important nutrients lacking in&#xD;
      Western diets today. The average person in developing countries consumes less than 100 mg of&#xD;
      DHA daily. With increasing awareness of the importance of DHA, many people realize that they&#xD;
      need to make a change in their diet by adding DHA-rich foods or supplements.&#xD;
&#xD;
      The aim of this study is to learn the effect of different supplementations from the omega 3&#xD;
      group on the maternal and fetal fatty acid profile during pregnancy and to study their&#xD;
      epigenetic influence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      DHA (Docosahexaenoic Acid ) is a long chain omega-3 fatty acid important for brain and eye&#xD;
      development and function throughout life. It also supports heart health. DHA is the most&#xD;
      abundant omega-3 in the brain and retina and is naturally found in breast milk. EPA&#xD;
      (Eicosapentaenoic Acid ) is a long-chain omega-3 fatty acid important for overall health.&#xD;
      However, unlike DHA, the body does not store EPA in significant quantities in the brain or&#xD;
      retina (DHA is found in every cell throughout the body, EPA is not). These Omega 3 fatty&#xD;
      acids are considered essential due to the inability of the human body to create them and the&#xD;
      need to consume them from nutritional source. Food that is considered rich in omega 3 fatty&#xD;
      acids are fat fish and green vegetables. Omega-3 fatty acids are &quot;good fats,&quot; and are among&#xD;
      the most important nutrients lacking in Western diets today. The average person in developing&#xD;
      countries consumes less than 100 mg of DHA daily. With increasing awareness of the importance&#xD;
      of DHA, many people realize that they need to make a change in their diet by adding DHA-rich&#xD;
      foods or supplements.&#xD;
&#xD;
      Alpha Linolenic Acid (ALA) is a shorter-chain omega-3 that serves as a source of energy and&#xD;
      as a building block for long-chain omega-3 fatty acids (DHA and EPA). This precursor for&#xD;
      omega 3 fatty acid is abundant in falx seeds. The mother and the fetus has the metabolic&#xD;
      mechanism that enables them to transform ALA into EPA,DHA endogenously.&#xD;
&#xD;
      Women during pregnancy are predisposed to a reduction in unsaturated long chain fatty acid&#xD;
      (Polyunsaturated Fatty Acid = PUFA) from the omega 3 group . Lately, a new hypothesis&#xD;
      claiming that a reduced level of this essential acids expose the fetus later in his adult&#xD;
      life to a spectrum of metabolic and cardiovascular disease. New publication on animal models&#xD;
      showed higher rates of obesity, insulin resistance diabetes and cardiovascular damage on mice&#xD;
      exposed short chain fatty acids compared to those treated with enriched ALA diet&#xD;
      supplementation. Different nutritional and gynecological health organization around the world&#xD;
      including the FDA, recommend incorporating omega 3 fatty acids supplementation to daily diet&#xD;
      and specifically in pregnant women in order to raise their blood levels for the developing&#xD;
      fetus. However, normal fatty acid profile of the omega 3 group in mother and fetus haven't&#xD;
      been described yet. Furthermore, the total effect and future benefit to fetus haven't been&#xD;
      thoroughly studied and is based mainly on presumptions.&#xD;
&#xD;
      The aim of this study is to learn the effect of different supplementations from the omega 3&#xD;
      group on the maternal and fetal fatty acid profile during pregnancy and to study their&#xD;
      epigenetic influence.&#xD;
&#xD;
      Study methods:&#xD;
&#xD;
      Women 12 weeks of gestation visiting high risk unit and fitting inclusion criteria will be&#xD;
      offered to participate in the study. Demographic, medical and obstetrical information will be&#xD;
      collected from medical files after giving signed informed consent .&#xD;
&#xD;
      Each participant will be randomly assigned to one of three arms of the study based on the&#xD;
      order of being recruited (1- to first group, 2- to second group, 3 - to third group, 4- to&#xD;
      first group, etc.). Randomization will be done by the principal investigator that is not one&#xD;
      of the high risk unit team, and will be blinded to the participants and the treating doctor.&#xD;
&#xD;
      Group 1: Enriched diet with 2 capsules of ALA supplementation a day - 630 mg in each capsule.&#xD;
      Total amount of 1260 mg (Daily recommended dose is 1-2 g).&#xD;
&#xD;
      Group 2: Enriched diet with 2 capsules of DHA+EPA supplementation a day (Each capsule consist&#xD;
      of 240 mg DHA and 360 mg EPA) Group 3: Control group - Will receive 2 placebo capsule a day&#xD;
      (All products will be supplied by the same company that is approved by the FDA and the&#xD;
      Israeli health ministry) Follow up will take place on every visit to the high risk unit that&#xD;
      is 3 and 2 weeks apart at the second and third trimester, respectively. On each visit one&#xD;
      blood tube that include 5cc of blood will be taken for fatty acid profile analysis and on&#xD;
      labor 2 blood tubes will be taken from the mother and from the umbilical cord after&#xD;
      separation of the placenta : 1- for fatty acid analysis , 2- for PCR evaluation of mRNAs of&#xD;
      genes that were found correlated in animal models to be influenced by maternal diet during&#xD;
      pregnancy and are connected to metabolic syndrome pathologies in adulthood ( including -&#xD;
      FASn, Elov6, PPAR (α, β/δ, γ), SCD1, Fads2, SREBP-1 Ppargc1alpha, Lpin1, Plin5 , MAPK/PGC-1α.&#xD;
      (&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Problems executing the study&#xD;
  </why_stopped>
  <start_date type="Anticipated">February 1, 2022</start_date>
  <completion_date type="Anticipated">April 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Levels of Omega 3 fatty acids ( DHA, EPA, ALA)</measure>
    <time_frame>Change in maternal levels of Omega 3 fatty acids ( DHA, EPA, ALA) from recruitment (12 week of gestation ) until delivery .</time_frame>
    <description>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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Expression of messenger RNAs ( mRNAs) between the study groups</measure>
    <time_frame>At delivery - Immediately after separation of the placenta ( Blood sample from the mother and from the umbilical cord)</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Omega 3 Supplements During Pregnancy</condition>
  <arm_group>
    <arm_group_label>Alpha Linolenic Acid enriched diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Omega 3 enriched diet ( DHA+EPA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enriched diet with 2 capsules of DHA+EPA supplementation a day (Each capsule consist of 240 mg DHA and 360 mg EPA).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Control group - Will receive 2 placebo capsule a day - containing olive oil</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Alpha Linolenic Acid</intervention_name>
    <description>Alpha Linolenic Acid enriched diet</description>
    <arm_group_label>Alpha Linolenic Acid enriched diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Omega 3 enriched diet ( DHA+EPA)</intervention_name>
    <description>Omega 3 (DHA+EPA) supplementation enriched diet</description>
    <arm_group_label>Omega 3 enriched diet ( DHA+EPA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo capsules containing olive oil</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-42&#xD;
&#xD;
          -  Singleton&#xD;
&#xD;
          -  Gestational age 12-16 during first visit at the high risk unit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Liver Disease&#xD;
&#xD;
          -  Dyslipidemia&#xD;
&#xD;
          -  Twins&#xD;
&#xD;
          -  Warfarin, LMWH, Heparin use ( Due to suspected drug interaction that has been reported&#xD;
             however has not been proven yet)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Pregnant women</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Israel Hendler, M.D</last_name>
    <role>Study Director</role>
    <affiliation>Department of Obstetrics and Gynecology ,Sheba Medical Center, Ramat Gan, Israel</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alicia Leikin-Frenkel, M.D, Ph.d</last_name>
    <role>Study Director</role>
    <affiliation>Bert Strassburger Lipid Center, Sheba Medical Center, Ramat Gan, Israel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dr. A Mohr-Sasson</name>
      <address>
        <city>Ramat-Gan</city>
        <zip>56506</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <results_reference>
    <citation>Liu JC, Raine A, Ang RP, Fung DS. An analysis of blinding success in a randomised controlled trial of fish oil omega-3 fatty acids. Ann Acad Med Singap. 2015 Mar;44(3):85-91.</citation>
    <PMID>25882235</PMID>
  </results_reference>
  <results_reference>
    <citation>Grey A, Bolland M. Clinical trial evidence and use of fish oil supplements. JAMA Intern Med. 2014 Mar;174(3):460-2. doi: 10.1001/jamainternmed.2013.12765. No abstract available.</citation>
    <PMID>24352849</PMID>
  </results_reference>
  <results_reference>
    <citation>Tsyb AF, Parshkov EM, Sokolov VA. [Major trends of research at the Research Institute of Medical Radiology of the USSR Academy of Medical Sciences under the 12th 5-Year Plan]. Med Radiol (Mosk). 1987 Sep;32(9):6-10. No abstract available. Russian.</citation>
    <PMID>3657456</PMID>
  </results_reference>
  <results_reference>
    <citation>Hure A, Young A, Smith R, Collins C. Diet and pregnancy status in Australian women. Public Health Nutr. 2009 Jun;12(6):853-61. doi: 10.1017/S1368980008003212. Epub 2008 Jul 23.</citation>
    <PMID>18647425</PMID>
  </results_reference>
  <results_reference>
    <citation>Diet, nutrition and the prevention of chronic diseases. World Health Organ Tech Rep Ser. 2003;916:i-viii, 1-149, backcover.</citation>
    <PMID>12768890</PMID>
  </results_reference>
  <results_reference>
    <citation>Kris-Etherton PM, Innis S, Ammerican Dietetic Assocition, Dietitians of Canada. Position of the American Dietetic Association and Dietitians of Canada: dietary fatty acids. J Am Diet Assoc. 2007 Sep;107(9):1599-611. Erratum In: J Am Diet Assoc. 2007 Dec;107(12):2151.</citation>
    <PMID>17936958</PMID>
  </results_reference>
  <results_reference>
    <citation>Harris WS, Mozaffarian D, Lefevre M, Toner CD, Colombo J, Cunnane SC, Holden JM, Klurfeld DM, Morris MC, Whelan J. Towards establishing dietary reference intakes for eicosapentaenoic and docosahexaenoic acids. J Nutr. 2009 Apr;139(4):804S-19S. doi: 10.3945/jn.108.101329. Epub 2009 Feb 25.</citation>
    <PMID>19244379</PMID>
  </results_reference>
  <results_reference>
    <citation>Innis SM. Essential fatty acid transfer and fetal development. Placenta. 2005 Apr;26 Suppl A:S70-5. doi: 10.1016/j.placenta.2005.01.005.</citation>
    <PMID>15837071</PMID>
  </results_reference>
  <results_reference>
    <citation>Weaver KL, Ivester P, Seeds M, Case LD, Arm JP, Chilton FH. Effect of dietary fatty acids on inflammatory gene expression in healthy humans. J Biol Chem. 2009 Jun 5;284(23):15400-7. doi: 10.1074/jbc.M109.004861. Epub 2009 Apr 9.</citation>
    <PMID>19359242</PMID>
  </results_reference>
  <results_reference>
    <citation>Casanova MA, Medeiros F, Trindade M, Cohen C, Oigman W, Neves MF. Omega-3 fatty acids supplementation improves endothelial function and arterial stiffness in hypertensive patients with hypertriglyceridemia and high cardiovascular risk. J Am Soc Hypertens. 2017 Jan;11(1):10-19. doi: 10.1016/j.jash.2016.10.004. Epub 2016 Oct 26.</citation>
    <PMID>27876342</PMID>
  </results_reference>
  <results_reference>
    <citation>Shomonov-Wagner L, Raz A, Leikin-Frenkel A. Alpha linolenic acid in maternal diet halts the lipid disarray due to saturated fatty acids in the liver of mice offspring at weaning. Lipids Health Dis. 2015 Feb 26;14:14. doi: 10.1186/s12944-015-0012-7.</citation>
    <PMID>25889505</PMID>
  </results_reference>
  <results_reference>
    <citation>Hollander KS, Tempel Brami C, Konikoff FM, Fainaru M, Leikin-Frenkel A. Dietary enrichment with alpha-linolenic acid during pregnancy attenuates insulin resistance in adult offspring in mice. Arch Physiol Biochem. 2014 Jul;120(3):99-111. doi: 10.3109/13813455.2014.940352. Epub 2014 Jul 17.</citation>
    <PMID>25030769</PMID>
  </results_reference>
  <results_reference>
    <citation>Leikin-Frenkel AI. Is there A Role for Alpha-Linolenic Acid in the Fetal Programming of Health? J Clin Med. 2016 Mar 23;5(4):40. doi: 10.3390/jcm5040040.</citation>
    <PMID>27023621</PMID>
  </results_reference>
  <results_reference>
    <citation>Leikin-Frenkel A, Shomonov-Wagner L, Juknat A, Pasmanik-Chor M. Maternal Diet Enriched with alpha-Linolenic or Saturated Fatty Acids Differentially Regulates Gene Expression in the Liver of Mouse Offspring. J Nutrigenet Nutrigenomics. 2015;8(4-6):185-94. doi: 10.1159/000442945. Epub 2016 Jan 21.</citation>
    <PMID>26788914</PMID>
  </results_reference>
  <results_reference>
    <citation>Leikin-Frenkel A, Goldiner I, Leikin-Gobbi D, Rosenberg R, Bonen H, Litvak A, Bernheim J, Konikoff FM, Gilat T. Treatment of preestablished diet-induced fatty liver by oral fatty acid-bile acid conjugates in rodents. Eur J Gastroenterol Hepatol. 2008 Dec;20(12):1205-13. doi: 10.1097/MEG.0b013e3282fc9743.</citation>
    <PMID>18989145</PMID>
  </results_reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>April 6, 2022</last_update_submitted>
  <last_update_submitted_qc>April 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sheba Medical Center</investigator_affiliation>
    <investigator_full_name>Dr. Aya Mohr-Sasson</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Omega 3</keyword>
  <keyword>Supplements</keyword>
  <keyword>Alpha Linolenic Acid</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03040856
org study id: 3503-16-SMC
nct id: NCT03040856
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
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.
      (
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: 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 .
description: 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).
measure: 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)
description: 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)
arm group label: Alpha Linolenic Acid enriched diet
arm group type: Experimental
description: 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).
arm group label: Omega 3 enriched diet ( DHA+EPA)
arm group type: Experimental
description: Enriched diet with 2 capsules of DHA+EPA supplementation a day (Each capsule consist of 240 mg DHA and 360 mg EPA).
arm group label: Placebo
arm group type: Placebo Comparator
description: Control group - Will receive 2 placebo capsule a day - containing olive oil
intervention type: Dietary Supplement
intervention name: Alpha Linolenic Acid
description: Alpha Linolenic Acid enriched diet
arm group label: Alpha Linolenic Acid enriched diet
intervention type: Dietary Supplement
intervention name: Omega 3 enriched diet ( DHA+EPA)
description: Omega 3 (DHA+EPA) supplementation enriched diet
arm group label: Omega 3 enriched diet ( DHA+EPA)
intervention type: Other
intervention name: Placebo
description: Placebo capsules containing olive oil
arm group label: Placebo
criteria: 
gender: Female
gender based: Yes
gender description: Pregnant women
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Israel Hendler, M.D
role: Study Director
affiliation: Department of Obstetrics and Gynecology ,Sheba Medical Center, Ramat Gan, Israel
last name: Alicia Leikin-Frenkel, M.D, Ph.d
role: Study Director
affiliation: Bert Strassburger Lipid Center, Sheba Medical Center, Ramat Gan, Israel
facility: 
country: Israel
citation: Liu JC, Raine A, Ang RP, Fung DS. An analysis of blinding success in a randomised controlled trial of fish oil omega-3 fatty acids. Ann Acad Med Singap. 2015 Mar;44(3):85-91.
PMID: 25882235
citation: Grey A, Bolland M. Clinical trial evidence and use of fish oil supplements. JAMA Intern Med. 2014 Mar;174(3):460-2. doi: 10.1001/jamainternmed.2013.12765. No abstract available.
PMID: 24352849
citation: Tsyb AF, Parshkov EM, Sokolov VA. [Major trends of research at the Research Institute of Medical Radiology of the USSR Academy of Medical Sciences under the 12th 5-Year Plan]. Med Radiol (Mosk). 1987 Sep;32(9):6-10. No abstract available. Russian.
PMID: 3657456
citation: Hure A, Young A, Smith R, Collins C. Diet and pregnancy status in Australian women. Public Health Nutr. 2009 Jun;12(6):853-61. doi: 10.1017/S1368980008003212. Epub 2008 Jul 23.
PMID: 18647425
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responsible party type: Principal Investigator
investigator affiliation: Sheba Medical Center
investigator full name: Dr. Aya Mohr-Sasson
investigator title: Principal Investigator
sharing ipd: No