The Effect of Alpha Linolenic Acid (ALA) Supplementation During Pregnancy
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|ClinicalTrials.gov Identifier: NCT03040856|
Recruitment Status : Not yet recruiting
First Posted : February 2, 2017
Last Update Posted : June 9, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
|Estimated Study Start Date :||August 1, 2020|
|Estimated Primary Completion Date :||February 1, 2022|
|Estimated Study Completion Date :||February 1, 2022|
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
Placebo capsules containing olive oil
- 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).
- 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)
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
|Contact: Aya Mohr Sasson, M.Dfirstname.lastname@example.org|
|Dr. A Mohr-Sasson|
|Ramat-Gan, Israel, 56506|
|Contact: Dr. A Mohr-Sasson 97235302777 ext 97235302777 email@example.com|
|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|