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

Condition(s) targeted: Overweight; Obesity

Intervention: Marinol D-40 starting from 15 wk gestation until 4 mo pp (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: Technische Universität München

Official(s) and/or principal investigator(s):
Hans Hauner, Prof., Principal Investigator, Affiliation: Else Kröner-Fresenius-Zentrum für Ernährungsmedizin, Technische Universität München

Overall contact:
Hans Hauner, Prof., Phone: +49 89 4140, Ext: 6770, Email: hans.hauner@lrz.tu-muenchen.de

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.

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

Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: body fat mass of newborns

Secondary outcome:

body weight of newborns

body height of newborns

head circumference of newborns

blood lipids of pregnant and lactating women

fatty acid profile of plasma phospholipids and erythrocyte membrane lipids

daily intake of maternal fatty acids

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.

Minimum age: 18 Years. Maximum age: 43 Years. Gender(s): Female.

Criteria:

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

Hans Hauner, Prof., Phone: +49 89 4140, Ext: 6770, Email: hans.hauner@lrz.tu-muenchen.de

Else Kröner-Fresenius-Zentrum für Ernährungsmedizin, Technische Universität München, Munich 81675, Germany; Recruiting
Hans Hauner, Prof., Phone: +49 89 4140, Ext: 6770, Email: hans.hauner@lrz.tu-muenchen.de
Ulrike Amann-Gassner, PhD, Phone: +49 89 4140, Ext: 6782, Email: ulrike.amann-gassner@wzw.tum.de
Hans Hauner, Prof., Principal Investigator

Starting date: June 2006
Ending date: August 2009
Last updated: January 11, 2007