Fatty Acids During Pregnancy and Lactation and Body Fat Mass in Newborns
- Conditions
- OverweightObesity
- Interventions
- Dietary Supplement: Marinol D-40
- Registration Number
- NCT00362089
- Lead Sponsor
- Technical University of Munich
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 208
- Gestational age <= 15th week of gestation
- Age: 18-43 years
- Written informed consent
- Body mass index (BMI) before pregnancy between 18 and 30 km/m2
- High risk pregnancy
- Hypertonus
- Chronic diseases (i.e. diabetes mellitus)
- Psychiatric diseases
- Former supplementation with LC-PUFA
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Marinol Marinol D-40 Intervention group with Marinol D40 fish oil capsules
- Primary Outcome Measures
Name Time Method amount of fat mass in the offspring at birth, 6 weeks, 4 months, 1 year postpartum skinfold thickness measurements
- Secondary Outcome Measures
Name Time Method amount of fat mass in the offspring at 1,5 years, 2 years, 2.5 years, 3 years, 4 years and 5 years postpartum (follow-up) skinfold thickness measurements
offspring body height 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 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 15th wk gestation, 32nd wk gestation, 6 weeks pp, 4 months pp fatty acid profile of phospholipids and erythrocyte membrane lipids, fatty acid metabolites 15th wk gestation, 32nd wk gestation, birth, 6 wks, 4 months, 1 year, 3 years postpartum maternal and offspring blood cells and plasma, placenta, umbilical cord tissue, blood cells and plasma, breast milk
daily intake of maternal fatty acids 15 wks gestation, 32nd wks gestation, 6 wks pp 7 day dietary records
offspring abdominal subcutaneous and preperitoneal fat 6 weeks, 4 months , 1 year , 1.5 years , 2 years, 2.5 years, 3 years, 4 years, 5 years postpartum Ultrasonography
offspring fat mass, abdominal fat 6 weeks, 4 months, 5 years postpartum magnetic resonance imaging
maternal and offspring DNA analysis (SNPs, DNA methylation) 15 wk gestation, 32nd wk gestation (maternal), birth, 3 years (offspring) placenta, umbilical cord tissue, white blood cells
epigenetic analyses (histone modification, DNA methylation) birth placenta, umbilical cord tissue, white blood cells
cytokines, adipokines and hormone analysis 15th wk gestation, 32nd wk gestation, 6 wks pp, 4 months pp (maternal), birth, 4 months, 1 year, 3 years postpartum (offspring) maternal and offspring blood cells and plasma, placenta, umbilical cord blood cells and plasma, breast milk
protein analysis, proteomics 15th wk gestation, 32nd wk gestation (maternal), birth, 4 months, 1 year, 3 years postpartum (offspring) maternal and offspring blood cells and plasma, placenta, umbilical cord blood cells and plasma
metabolomics, lipidomics 15th wk gestation, 32nd wk gestation (maternal), birth, 4 months, 1 year, 3 years postpartum (offspring) maternal and offspring blood cells and plasma, placenta, umbilical cord blood cells and plasma
breast milk oligosaccharides 6 wks and 4 months postpartum offspring atopic eczema 1.5 years - 5 years postpartum parent questionnaire
offspring allergic diseases (asthma, rhinitis) 5 years postpartum parent questionnaire
developmental evaluation of children 2 years - 5 years postpartum parent questionnaire (based on Minnesota Scales)
motor development of children 4 years and 5 years postpartum physical activity of children 2 years - 5 years postpartum parent questionnaire
maternal and offspring gene expression (mRNA, miRNA) 15 wk gestation, 32nd wk gestation (maternal), birth, 3 years (offspring) placenta, umbilical cord tissue, white blood cells, blood plasma
dietary intake of children 2 years - 5 years postpartum 3 day dietary record
offspring body weight at birth, 6 weeks, 4 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 4 years and 5 years postpartum
Trial Locations
- Locations (1)
Else Kröner-Fresenius-Zentrum für Ernährungsmedizin, Technische Universität München
🇩🇪Munich, Germany