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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2010-11-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Marinol

Intervention group with Marinol D40 fish oil capsules

Group Type ACTIVE_COMPARATOR

Marinol D-40

Intervention Type DIETARY_SUPPLEMENT

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

Nutrition counseling

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Marinol D-40

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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