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

This study has been completed.
Sponsor:
Collaborators:
Else Kröner-Fresenius-Foundation; International Unilever-Foundation; Danone Research
EU funding by EARNEST consortium;German Ministry of Education and Research GF-GFGI01120708)
Information provided by (Responsible Party):
Ulrike Amann-Gassner, Technische Universität München
ClinicalTrials.gov Identifier:
NCT00362089
First received: August 8, 2006
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Overweight
Obesity
Dietary Supplement: Marinol D-40

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Impact of the Nutritional Fatty Acids During Pregnancy and Lactation for Early Human Adipose Tissue Development

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • amount of fat mass in the offspring [ Time Frame: at birth, 6 weeks, 4 months, 1 year postpartum ] [ Designated as safety issue: No ]
    skinfold thickness measurements


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    skinfold thickness measurements

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • blood lipids of pregnant and lactating women [ Time Frame: 15th wk gestation, 32nd wk gestation, 6 weeks pp, 4 months pp ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    maternal and offspring blood cells and plasma, placenta, umbilical cord tissue, blood cells and plasma, breast milk

  • daily intake of maternal fatty acids [ Time Frame: 15 wks gestation, 32nd wks gestation, 6 wks pp ] [ Designated as safety issue: No ]
    7 day dietary records

  • 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 ] [ Designated as safety issue: No ]
    Ultrasonography

  • offspring fat mass, abdominal fat [ Time Frame: 6 weeks, 4 months, 5 years postpartum ] [ Designated as safety issue: No ]
    magnetic resonance imaging

  • maternal and offspring gene expression (mRNA, miRNA) [ Time Frame: 15 wk gestation, 32nd wk gestation (maternal), birth, 3 years (offspring) ] [ Designated as safety issue: No ]
    placenta, umbilical cord tissue, white blood cells, blood plasma

  • maternal and offspring DNA analysis (SNPs, DNA methylation) [ Time Frame: 15 wk gestation, 32nd wk gestation (maternal), birth, 3 years (offspring) ] [ Designated as safety issue: No ]
    placenta, umbilical cord tissue, white blood cells

  • epigenetic analyses (histone modification, DNA methylation) [ Time Frame: birth ] [ Designated as safety issue: No ]
    placenta, umbilical cord tissue, white blood cells

  • 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) ] [ Designated as safety issue: No ]
    maternal and offspring blood cells and plasma, placenta, umbilical cord blood cells and plasma, breast milk

  • protein analysis, proteomics [ Time Frame: 15th wk gestation, 32nd wk gestation (maternal), birth, 4 months, 1 year, 3 years postpartum (offspring) ] [ Designated as safety issue: No ]
    maternal and offspring blood cells and plasma, placenta, umbilical cord blood cells and plasma

  • metabolomics, lipidomics [ Time Frame: 15th wk gestation, 32nd wk gestation (maternal), birth, 4 months, 1 year, 3 years postpartum (offspring) ] [ Designated as safety issue: No ]
    maternal and offspring blood cells and plasma, placenta, umbilical cord blood cells and plasma

  • breast milk oligosaccharides [ Time Frame: 6 wks and 4 months postpartum ] [ Designated as safety issue: No ]
  • offspring atopic eczema [ Time Frame: 1.5 years - 5 years postpartum ] [ Designated as safety issue: No ]
    parent questionnaire

  • offspring allergic diseases (asthma, rhinitis) [ Time Frame: 5 years postpartum ] [ Designated as safety issue: No ]
    parent questionnaire

  • developmental evaluation of children [ Time Frame: 2 years - 5 years postpartum ] [ Designated as safety issue: No ]
    parent questionnaire (based on Minnesota Scales)

  • motor development of children [ Time Frame: 4 years and 5 years postpartum ] [ Designated as safety issue: No ]
  • physical activity of children [ Time Frame: 2 years - 5 years postpartum ] [ Designated as safety issue: No ]
    parent questionnaire

  • dietary intake of children [ Time Frame: 2 years - 5 years postpartum ] [ Designated as safety issue: No ]
    3 day dietary record

  • 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 ] [ Designated as safety issue: No ]

Enrollment: 208
Study Start Date: June 2006
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Marinol
Intervention group with Marinol D40 fish oil capsules
Dietary Supplement: Marinol D-40
Marinol D-40, three capsules per day, from 15th week of gestation until 4th month of lactation
No Intervention: Nutrition counseling
Control group

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.

  Eligibility

Ages Eligible for Study:   18 Years to 43 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362089

Locations
Germany
Else Kröner-Fresenius-Zentrum für Ernährungsmedizin, Technische Universität München
Munich, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Else Kröner-Fresenius-Foundation; International Unilever-Foundation; Danone Research
EU funding by EARNEST consortium;German Ministry of Education and Research GF-GFGI01120708)
Investigators
Principal Investigator: Hans Hauner, Prof. Else Kröner-Fresenius-Zentrum für Ernährungsmedizin, Technische Universität München
  More Information

Publications:

Responsible Party: Ulrike Amann-Gassner, PhD, Technische Universität München
ClinicalTrials.gov Identifier: NCT00362089     History of Changes
Other Study ID Numbers: EKFZ001_CN, INFAT
Study First Received: August 8, 2006
Last Updated: February 3, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Technische Universität München:
n-3 fatty acids
n-6 fatty acids
long chain polyunsaturated fatty acids
pregnancy
lactation
breast feeding
breast milk
adipose tissue
newborn
fetal development

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms
Dronabinol
Analgesics
Analgesics, Non-Narcotic
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Central Nervous System Agents
Hallucinogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014