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
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Levels of Omega 3 fatty acids ( DHA, EPA, ALA)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-42
- •Singleton
- •Gestational age 12-16 during first visit at the high risk unit
排除标准
- •Liver Disease
- •Dyslipidemia
- •Warfarin, LMWH, Heparin use ( Due to suspected drug interaction that has been reported however has not been proven yet)
结局指标
主要结局
Levels of Omega 3 fatty acids ( DHA, EPA, ALA)
时间窗: 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).
次要结局
- Expression of messenger RNAs ( mRNAs) between the study groups(At delivery - Immediately after separation of the placenta ( Blood sample from the mother and from the umbilical cord))
研究者
Dr. Aya Mohr-Sasson
Principal Investigator
Sheba Medical Center
