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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
208
Marinol D-40, three capsules per day, from 15th week of gestation until 4th month of lactation
Else Kröner-Fresenius-Zentrum für Ernährungsmedizin, Technische Universität München
Munich, Germany
amount of fat mass in the offspring
skinfold thickness measurements
Time frame: at birth, 6 weeks, 4 months, 1 year postpartum
amount of fat mass in the offspring
skinfold thickness measurements
Time frame: at 1,5 years, 2 years, 2.5 years, 3 years, 4 years and 5 years postpartum (follow-up)
offspring body height
Time frame: at birth, 6 weeks, 4 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 4 years and 5 years postpartum
head circumference of newborns, infants and children
Time frame: at birth, 6 weeks, 4 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 4 years and 5 years postpartum
blood lipids of pregnant and lactating women
Time frame: 15th wk gestation, 32nd wk gestation, 6 weeks pp, 4 months pp
fatty acid profile of phospholipids and erythrocyte membrane lipids, fatty acid metabolites
maternal and offspring blood cells and plasma, placenta, umbilical cord tissue, blood cells and plasma, breast milk
Time frame: 15th wk gestation, 32nd wk gestation, birth, 6 wks, 4 months, 1 year, 3 years postpartum
daily intake of maternal fatty acids
7 day dietary records
Time frame: 15 wks gestation, 32nd wks gestation, 6 wks pp
offspring abdominal subcutaneous and preperitoneal fat
Ultrasonography
Time frame: 6 weeks, 4 months , 1 year , 1.5 years , 2 years, 2.5 years, 3 years, 4 years, 5 years postpartum
offspring fat mass, abdominal fat
magnetic resonance imaging
Time frame: 6 weeks, 4 months, 5 years postpartum
maternal and offspring gene expression (mRNA, miRNA)
placenta, umbilical cord tissue, white blood cells, blood plasma
Time frame: 15 wk gestation, 32nd wk gestation (maternal), birth, 3 years (offspring)
maternal and offspring DNA analysis (SNPs, DNA methylation)
placenta, umbilical cord tissue, white blood cells
Time frame: 15 wk gestation, 32nd wk gestation (maternal), birth, 3 years (offspring)
epigenetic analyses (histone modification, DNA methylation)
placenta, umbilical cord tissue, white blood cells
Time frame: birth
cytokines, adipokines and hormone analysis
maternal and offspring blood cells and plasma, placenta, umbilical cord blood cells and plasma, breast milk
Time frame: 15th wk gestation, 32nd wk gestation, 6 wks pp, 4 months pp (maternal), birth, 4 months, 1 year, 3 years postpartum (offspring)
protein analysis, proteomics
maternal and offspring blood cells and plasma, placenta, umbilical cord blood cells and plasma
Time frame: 15th wk gestation, 32nd wk gestation (maternal), birth, 4 months, 1 year, 3 years postpartum (offspring)
metabolomics, lipidomics
maternal and offspring blood cells and plasma, placenta, umbilical cord blood cells and plasma
Time frame: 15th wk gestation, 32nd wk gestation (maternal), birth, 4 months, 1 year, 3 years postpartum (offspring)
breast milk oligosaccharides
Time frame: 6 wks and 4 months postpartum
offspring atopic eczema
parent questionnaire
Time frame: 1.5 years - 5 years postpartum
offspring allergic diseases (asthma, rhinitis)
parent questionnaire
Time frame: 5 years postpartum
developmental evaluation of children
parent questionnaire (based on Minnesota Scales)
Time frame: 2 years - 5 years postpartum
motor development of children
Time frame: 4 years and 5 years postpartum
physical activity of children
parent questionnaire
Time frame: 2 years - 5 years postpartum
dietary intake of children
3 day dietary record
Time frame: 2 years - 5 years postpartum
offspring body weight
Time frame: at birth, 6 weeks, 4 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 4 years and 5 years postpartum
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