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Fatty Acids During Pregnancy and Lactation and Body Fat Mass in Newborns

The Impact of the Nutritional Fatty Acids During Pregnancy and Lactation for Early Human Adipose Tissue Development

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00362089
Enrollment
208
Registered
2006-08-09
Start date
2006-06-30
Completion date
2010-11-30
Last updated
2014-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

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

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.

Interventions

DIETARY_SUPPLEMENTMarinol D-40

Marinol D-40, three capsules per day, from 15th week of gestation until 4th month of lactation

Sponsors

Else Kröner-Fresenius-Foundation; International Unilever-Foundation; Danone Research
CollaboratorUNKNOWN
EU funding by EARNEST consortium;German Ministry of Education and Research GF-GFGI01120708)
CollaboratorUNKNOWN
Technical University of Munich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* High risk pregnancy * Hypertonus * Chronic diseases (i.e. diabetes mellitus) * Psychiatric diseases * Former supplementation with LC-PUFA

Design outcomes

Primary

MeasureTime frameDescription
amount of fat mass in the offspringat birth, 6 weeks, 4 months, 1 year postpartumskinfold thickness measurements

Secondary

MeasureTime frameDescription
offspring body heightat 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 childrenat 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 women15th wk gestation, 32nd wk gestation, 6 weeks pp, 4 months pp
fatty acid profile of phospholipids and erythrocyte membrane lipids, fatty acid metabolites15th wk gestation, 32nd wk gestation, birth, 6 wks, 4 months, 1 year, 3 years postpartummaternal and offspring blood cells and plasma, placenta, umbilical cord tissue, blood cells and plasma, breast milk
daily intake of maternal fatty acids15 wks gestation, 32nd wks gestation, 6 wks pp7 day dietary records
offspring abdominal subcutaneous and preperitoneal fat6 weeks, 4 months , 1 year , 1.5 years , 2 years, 2.5 years, 3 years, 4 years, 5 years postpartumUltrasonography
offspring fat mass, abdominal fat6 weeks, 4 months, 5 years postpartummagnetic resonance imaging
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
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)birthplacenta, umbilical cord tissue, white blood cells
amount of fat mass in the offspringat 1,5 years, 2 years, 2.5 years, 3 years, 4 years and 5 years postpartum (follow-up)skinfold thickness measurements
protein analysis, proteomics15th 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, lipidomics15th 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 oligosaccharides6 wks and 4 months postpartum
offspring atopic eczema1.5 years - 5 years postpartumparent questionnaire
offspring allergic diseases (asthma, rhinitis)5 years postpartumparent questionnaire
developmental evaluation of children2 years - 5 years postpartumparent questionnaire (based on Minnesota Scales)
motor development of children4 years and 5 years postpartum
physical activity of children2 years - 5 years postpartumparent questionnaire
dietary intake of children2 years - 5 years postpartum3 day dietary record
offspring body weightat birth, 6 weeks, 4 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 4 years and 5 years postpartum
cytokines, adipokines and hormone analysis15th 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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026