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Completed

NCT Number: NCT00362089

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

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.

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Key information

Conditions

Overweight Behavior Body Weight Breast Feeding Feeding Behavior Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Else Kröner-Fresenius-Zentrum für Ernährungsmedizin, Technische Universität München

Munich, 81675, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Marinol D-40

Dietary Supplement

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

Primary outcomes

  1. amount of fat mass in the offspring

    Time frame: at birth, 6 weeks, 4 months, 1 year postpartum

    skinfold thickness measurements

Secondary outcomes

  1. amount of fat mass in the offspring

    Time frame: at 1,5 years, 2 years, 2.5 years, 3 years, 4 years and 5 years postpartum (follow-up)

    skinfold thickness measurements

  2. 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

  3. 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

  4. blood lipids of pregnant and lactating women

    Time frame: 15th wk gestation, 32nd wk gestation, 6 weeks pp, 4 months pp

  5. fatty acid profile of phospholipids and erythrocyte membrane lipids, fatty acid metabolites

    Time frame: 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

  6. daily intake of maternal fatty acids

    Time frame: 15 wks gestation, 32nd wks gestation, 6 wks pp

    7 day dietary records

  7. offspring abdominal subcutaneous and preperitoneal fat

    Time frame: 6 weeks, 4 months , 1 year , 1.5 years , 2 years, 2.5 years, 3 years, 4 years, 5 years postpartum

    Ultrasonography

  8. offspring fat mass, abdominal fat

    Time frame: 6 weeks, 4 months, 5 years postpartum

    magnetic resonance imaging

  9. maternal and offspring gene expression (mRNA, miRNA)

    Time frame: 15 wk gestation, 32nd wk gestation (maternal), birth, 3 years (offspring)

    placenta, umbilical cord tissue, white blood cells, blood plasma

  10. maternal and offspring DNA analysis (SNPs, DNA methylation)

    Time frame: 15 wk gestation, 32nd wk gestation (maternal), birth, 3 years (offspring)

    placenta, umbilical cord tissue, white blood cells

  11. epigenetic analyses (histone modification, DNA methylation)

    Time frame: birth

    placenta, umbilical cord tissue, white blood cells

  12. cytokines, adipokines and hormone analysis

    Time frame: 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

  13. protein analysis, proteomics

    Time frame: 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

  14. metabolomics, lipidomics

    Time frame: 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

  15. breast milk oligosaccharides

    Time frame: 6 wks and 4 months postpartum

  16. offspring atopic eczema

    Time frame: 1.5 years - 5 years postpartum

    parent questionnaire

  17. offspring allergic diseases (asthma, rhinitis)

    Time frame: 5 years postpartum

    parent questionnaire

  18. developmental evaluation of children

    Time frame: 2 years - 5 years postpartum

    parent questionnaire (based on Minnesota Scales)

  19. motor development of children

    Time frame: 4 years and 5 years postpartum

  20. physical activity of children

    Time frame: 2 years - 5 years postpartum

    parent questionnaire

  21. dietary intake of children

    Time frame: 2 years - 5 years postpartum

    3 day dietary record

  22. 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

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • EU funding by EARNEST consortium;German Ministry of Education and Research GF-GFGI01120708)
  • Else Kröner-Fresenius-Foundation; International Unilever-Foundation; Danone Research

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Aug 9, 2006
Registry last updated
Feb 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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