Fatty Acids During Pregnancy and Lactation and Body Fat Mass in Newborns
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Pregnant and lactating women receive n-3 fatty acids starting from week 15 of gestation until
      4 months post-partum (pp) in comparison to a control group, who only gets information about
      adequately healthy nutrition during pregnancy and lactation.

      The amount of fat in newborns is measured through skinfold thickness, ultrasound, and
      magnetic resonance imaging (MRI).

      It is hypothesised that a reduction in arachidonic acid intake and an increase of n-3 LC
      PUFAs (long chain polyunsaturated fatty acids) via supplements containing docosahexaenoic
      acid (DHA) and eicosapentaenoic acid (EPA) could lead to less expansive fat tissue
      development in the first year of life.
    

Detailed description: 
      The prevalence of overweight and obese children and adolescents dramatically increased during
      the last two decades. In Germany every 5th school child is overweight and 4 - 8% of all
      children are obese.

      Recent studies suggest that fatty acids in maternal nutrition may have an impact on the fat
      tissue development during the fetal period.

      Animal studies showed that a reduction in the arachidonic acid intake, a higher intake of n-3
      LC PUFAs (i.e. DHA and EPA) and a resulting lower n-6/n-3 fatty acid ratio in food will cause
      less expansive fat tissue development in the first year of life.

      In vitro studies and personal observations in animal studies also showed that n-6 fatty acids
      (i.e. arachidonic acid) stimulate the differentiation of preadipocytes to adipocytes whereas
      n-3 fatty acids (i.e. DHA and EPA) have the contrary effect.

      The impact of the maternal fatty acid pattern on the early fat tissue development can only be
      clarified in an intervention study.

      Therefore it is planned to recruit 204 pregnant women in the 14th week of gestation. They
      will be randomly assigned to the intervention or control group.

      The intervention group will receive n-3 LC-PUFAs (DHA and EPA) as fish oil capsules from the
      15th week of gestation until 4 months pp, the control group will get nutrition counselling
      according to the recommendations of the German Society for Nutrition during the same time
      period. Blood samples of the pregnant and lactating women, umbilical cord blood, placental
      tissue and blood of the newborns will be collected for fatty acid analysis.

      Body fat mass in newborns will be determined from delivery until 4 months pp via skinfold
      measurement, ultrasound, and MRI.

      The hypothesis is that newborns in the group of the "supplemented" mothers will have less
      expansive fat tissue development than children from mothers in the control group.

      This would be an innovative primary preventive approach in a period of increasing prevalence
      of overweight and obese children and adolescents.
    

Intervention name(s): Marinol D-40
Intervention type(s): Dietary Supplement
Intervention description(s): Marinol D-40, three capsules per day, from 15th week of gestation until 4th month of lactation
Intervention MeSH terms: Dronabinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: n-3 fatty acids; n-6 fatty acids; long chain polyunsaturated fatty acids; pregnancy; lactation; breast feeding; breast milk; adipose tissue; newborn; fetal development