The Effect of Alpha Linolenic Acid (ALA) Supplementation During Pregnancy
NCT ID: NCT03040856
Last Updated: 2022-04-14
Study Results
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Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2022-02-01
2022-04-01
Brief Summary
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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.
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Detailed Description
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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. (
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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).
Alpha Linolenic Acid
Alpha Linolenic Acid enriched diet
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).
Omega 3 enriched diet ( DHA+EPA)
Omega 3 (DHA+EPA) supplementation enriched diet
Placebo
Control group - Will receive 2 placebo capsule a day - containing olive oil
Placebo
Placebo capsules containing olive oil
Interventions
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Alpha Linolenic Acid
Alpha Linolenic Acid enriched diet
Omega 3 enriched diet ( DHA+EPA)
Omega 3 (DHA+EPA) supplementation enriched diet
Placebo
Placebo capsules containing olive oil
Eligibility Criteria
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Inclusion Criteria
* Singleton
* Gestational age 12-16 during first visit at the high risk unit
Exclusion Criteria
* Dyslipidemia
* Twins
* Warfarin, LMWH, Heparin use ( Due to suspected drug interaction that has been reported however has not been proven yet)
18 Years
45 Years
FEMALE
No
Sponsors
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Sheba Medical Center
OTHER_GOV
Responsible Party
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Dr. Aya Mohr-Sasson
Principal Investigator
Principal Investigators
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Israel Hendler, M.D
Role: STUDY_DIRECTOR
Department of Obstetrics and Gynecology ,Sheba Medical Center, Ramat Gan, Israel
Alicia Leikin-Frenkel, M.D, Ph.d
Role: STUDY_DIRECTOR
Bert Strassburger Lipid Center, Sheba Medical Center, Ramat Gan, Israel
Locations
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Dr. A Mohr-Sasson
Ramat Gan, , Israel
Countries
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References
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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.
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.
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.
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.
Diet, nutrition and the prevention of chronic diseases. World Health Organ Tech Rep Ser. 2003;916:i-viii, 1-149, backcover.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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3503-16-SMC
Identifier Type: -
Identifier Source: org_study_id
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