Effect of Omega-3 Supplementation During Pregnancy on Regulation of Stress
Condition: Healthy Pregnant Women
Study type: Interventional

Summary: 
      This will be the first study of the effect of essential fatty acid supplementation in
      pregnant women living in inner-city poverty on the stress response system during pregnancy.
      The investigators proposed that essential fatty acid supplementation will be associated with
      reductions in the experience of stress, more modulated hormonal response to stress, and more
      optimal regulation of emotion and attention in the infant, even within the context inner-city
      poverty.
    

Detailed description: 
      Significance: Pregnant women living in poverty often experience chronic stress, and
      consequently higher levels of stress hormones. In utero exposure to high levels of stress
      hormones can negatively affect the developing fetus and later, the infant's capacity for
      emotion and behavioral regulation. In this proposal we describe a developing program of
      research designed to reduce the negative impact of prenatal stress on infant health and
      development via nutritional supplementation of docosahexaenoic acid (DHA) during pregnancy.
      DHA is a long-chain polyunsaturated fatty acid member of the omega-3 fatty acid family. DHA
      is found in its highest concentrations in neural cell membranes, affecting receptor function,
      neurotransmitter uptake, and signal transmission. There is growing evidence that low levels
      of dietary DHA intake are associated with suboptimal response to stress and that DHA
      supplementation can modulate stress response. Aims: The goals of the proposed study are to
      explore whether DHA supplementation during pregnancy is associated with 1) a reduction in
      maternal perceived stress during pregnancy; 2) a more modulated maternal cortisol response to
      a stress stimulus during pregnancy, and 3) more optimal regulation of emotion and behavior in
      the infant. Approach: Sixty-five pregnant women living in inner-city poverty, who consume
      less than two servings of fish per week, will be randomly assigned to receive 450 mg/daily of
      DHA or placebo beginning at 16-20 weeks gestation through the end of pregnancy. Perceived
      stress, pregnancy related stress, stressful life events, anxiety, and depression will be
      assessed at baseline and at 24, 30, and 36 weeks of pregnancy and at 4 months post-partum.
      DHA levels will be assessed at baseline and at 36 weeks of pregnancy. Cortisol response to
      the Trier Social Stress Test will be measured at baseline, 24, and 30 weeks. At 4 months
      post-partum infant temperament, cognitive development and stress reactivity will be assessed
      in the laboratory. Investigators: This proposal stems from an National Institute of Mental
      Health R21 Translational Science Network on prenatal stress and mental health outcomes in the
      offspring. Three members of that network, Drs. Keenan, Carter, and Glover, are all funded
      investigators in the area of prenatal stress and child mental health, which is a prioritized
      area of exploratory research that could directly impact clinical care. They are collaborating
      on the present application. Innovation: This will be the first randomized controlled study of
      the effect of DHA supplementation on stress response in pregnant women living in inner-city
      poverty, and the first study of maternal DHA supplementation on emotion and stress regulation
      in their infants. Relevance: If DHA supplementation is associated with reductions in
      perceived stress, more modulated maternal cortisol response to stress, and more optimal
      emotional and behavioral regulation in the infant, even within the context inner-city
      poverty, then a comprehensive program of research on the mechanisms by which these
      associations evolve and the potential for broad-based prevention of poor developmental
      outcomes among children born to women living in poverty can be launched.
    

Intervention name(s): Docosahexanoic Acid; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery; soybean oils with strawberry flavoring
Other intervention name(s): Nordic Naturals ProDHA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science