Fatty Acids During Pregnancy and Lactation and Body Fat Mass in Newborns
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Marinol D-40
Sponsored by

About this trial
This is an interventional prevention trial for Overweight focused on measuring n-3 fatty acids, n-6 fatty acids, long chain polyunsaturated fatty acids, pregnancy, lactation, breast feeding, breast milk, adipose tissue, newborn, fetal development
Eligibility 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
Sites / Locations
- Else Kröner-Fresenius-Zentrum für Ernährungsmedizin, Technische Universität München
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Marinol
Nutrition counseling
Arm Description
Intervention group with Marinol D40 fish oil capsules
Control group
Outcomes
Primary Outcome Measures
amount of fat mass in the offspring
skinfold thickness measurements
Secondary Outcome Measures
amount of fat mass in the offspring
skinfold thickness measurements
offspring body height
head circumference of newborns, infants and children
blood lipids of pregnant and lactating women
fatty acid profile of phospholipids and erythrocyte membrane lipids, fatty acid metabolites
maternal and offspring blood cells and plasma, placenta, umbilical cord tissue, blood cells and plasma, breast milk
daily intake of maternal fatty acids
7 day dietary records
offspring abdominal subcutaneous and preperitoneal fat
Ultrasonography
offspring fat mass, abdominal fat
magnetic resonance imaging
maternal and offspring gene expression (mRNA, miRNA)
placenta, umbilical cord tissue, white blood cells, blood plasma
maternal and offspring DNA analysis (SNPs, DNA methylation)
placenta, umbilical cord tissue, white blood cells
epigenetic analyses (histone modification, DNA methylation)
placenta, umbilical cord tissue, white blood cells
cytokines, adipokines and hormone analysis
maternal and offspring blood cells and plasma, placenta, umbilical cord blood cells and plasma, breast milk
protein analysis, proteomics
maternal and offspring blood cells and plasma, placenta, umbilical cord blood cells and plasma
metabolomics, lipidomics
maternal and offspring blood cells and plasma, placenta, umbilical cord blood cells and plasma
breast milk oligosaccharides
offspring atopic eczema
parent questionnaire
offspring allergic diseases (asthma, rhinitis)
parent questionnaire
developmental evaluation of children
parent questionnaire (based on Minnesota Scales)
motor development of children
physical activity of children
parent questionnaire
dietary intake of children
3 day dietary record
offspring body weight
Full Information
NCT ID
NCT00362089
First Posted
August 8, 2006
Last Updated
February 3, 2014
Sponsor
Technical University of Munich
Collaborators
Else Kröner-Fresenius-Foundation; International Unilever-Foundation; Danone Research, EU funding by EARNEST consortium;German Ministry of Education and Research GF-GFGI01120708)
1. Study Identification
Unique Protocol Identification Number
NCT00362089
Brief Title
Fatty Acids During Pregnancy and Lactation and Body Fat Mass in Newborns
Official Title
The Impact of the Nutritional Fatty Acids During Pregnancy and Lactation for Early Human Adipose Tissue Development
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technical University of Munich
Collaborators
Else Kröner-Fresenius-Foundation; International Unilever-Foundation; Danone Research, EU funding by EARNEST consortium;German Ministry of Education and Research GF-GFGI01120708)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
208 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Marinol
Arm Type
Active Comparator
Arm Description
Intervention group with Marinol D40 fish oil capsules
Arm Title
Nutrition counseling
Arm Type
No Intervention
Arm Description
Control group
Intervention Type
Dietary Supplement
Intervention Name(s)
Marinol D-40
Intervention Description
Marinol D-40, three capsules per day, from 15th week of gestation until 4th month of lactation
Primary Outcome Measure Information:
Title
amount of fat mass in the offspring
Description
skinfold thickness measurements
Time Frame
at birth, 6 weeks, 4 months, 1 year postpartum
Secondary Outcome Measure Information:
Title
amount of fat mass in the offspring
Description
skinfold thickness measurements
Time Frame
at 1,5 years, 2 years, 2.5 years, 3 years, 4 years and 5 years postpartum (follow-up)
Title
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
Title
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
Title
blood lipids of pregnant and lactating women
Time Frame
15th wk gestation, 32nd wk gestation, 6 weeks pp, 4 months pp
Title
fatty acid profile of phospholipids and erythrocyte membrane lipids, fatty acid metabolites
Description
maternal and offspring blood cells and plasma, placenta, umbilical cord tissue, blood cells and plasma, breast milk
Time Frame
15th wk gestation, 32nd wk gestation, birth, 6 wks, 4 months, 1 year, 3 years postpartum
Title
daily intake of maternal fatty acids
Description
7 day dietary records
Time Frame
15 wks gestation, 32nd wks gestation, 6 wks pp
Title
offspring abdominal subcutaneous and preperitoneal fat
Description
Ultrasonography
Time Frame
6 weeks, 4 months , 1 year , 1.5 years , 2 years, 2.5 years, 3 years, 4 years, 5 years postpartum
Title
offspring fat mass, abdominal fat
Description
magnetic resonance imaging
Time Frame
6 weeks, 4 months, 5 years postpartum
Title
maternal and offspring gene expression (mRNA, miRNA)
Description
placenta, umbilical cord tissue, white blood cells, blood plasma
Time Frame
15 wk gestation, 32nd wk gestation (maternal), birth, 3 years (offspring)
Title
maternal and offspring DNA analysis (SNPs, DNA methylation)
Description
placenta, umbilical cord tissue, white blood cells
Time Frame
15 wk gestation, 32nd wk gestation (maternal), birth, 3 years (offspring)
Title
epigenetic analyses (histone modification, DNA methylation)
Description
placenta, umbilical cord tissue, white blood cells
Time Frame
birth
Title
cytokines, adipokines and hormone analysis
Description
maternal and offspring blood cells and plasma, placenta, umbilical cord blood cells and plasma, breast milk
Time Frame
15th wk gestation, 32nd wk gestation, 6 wks pp, 4 months pp (maternal), birth, 4 months, 1 year, 3 years postpartum (offspring)
Title
protein analysis, proteomics
Description
maternal and offspring blood cells and plasma, placenta, umbilical cord blood cells and plasma
Time Frame
15th wk gestation, 32nd wk gestation (maternal), birth, 4 months, 1 year, 3 years postpartum (offspring)
Title
metabolomics, lipidomics
Description
maternal and offspring blood cells and plasma, placenta, umbilical cord blood cells and plasma
Time Frame
15th wk gestation, 32nd wk gestation (maternal), birth, 4 months, 1 year, 3 years postpartum (offspring)
Title
breast milk oligosaccharides
Time Frame
6 wks and 4 months postpartum
Title
offspring atopic eczema
Description
parent questionnaire
Time Frame
1.5 years - 5 years postpartum
Title
offspring allergic diseases (asthma, rhinitis)
Description
parent questionnaire
Time Frame
5 years postpartum
Title
developmental evaluation of children
Description
parent questionnaire (based on Minnesota Scales)
Time Frame
2 years - 5 years postpartum
Title
motor development of children
Time Frame
4 years and 5 years postpartum
Title
physical activity of children
Description
parent questionnaire
Time Frame
2 years - 5 years postpartum
Title
dietary intake of children
Description
3 day dietary record
Time Frame
2 years - 5 years postpartum
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Hauner, Prof.
Organizational Affiliation
Else Kröner-Fresenius-Zentrum für Ernährungsmedizin, Technische Universität München
Official's Role
Principal Investigator
Facility Information:
Facility Name
Else Kröner-Fresenius-Zentrum für Ernährungsmedizin, Technische Universität München
City
Munich
ZIP/Postal Code
81675
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
19295192
Citation
Hauner H, Vollhardt C, Schneider KT, Zimmermann A, Schuster T, Amann-Gassner U. The impact of nutritional fatty acids during pregnancy and lactation on early human adipose tissue development. Rationale and design of the INFAT study. Ann Nutr Metab. 2009;54(2):97-103. doi: 10.1159/000209267. Epub 2009 Mar 19.
Results Reference
background
PubMed Identifier
23340492
Citation
Much D, Brunner S, Vollhardt C, Schmid D, Sedlmeier EM, Bruderl M, Heimberg E, Bartke N, Boehm G, Bader BL, Amann-Gassner U, Hauner H. Effect of dietary intervention to reduce the n-6/n-3 fatty acid ratio on maternal and fetal fatty acid profile and its relation to offspring growth and body composition at 1 year of age. Eur J Clin Nutr. 2013 Mar;67(3):282-8. doi: 10.1038/ejcn.2013.2. Epub 2013 Jan 23.
Results Reference
background
PubMed Identifier
23596009
Citation
Brunner S, Schmid D, Huttinger K, Much D, Bruderl M, Sedlmeier EM, Kratzsch J, Amann-Gassnerl U, Bader BL, Hauner H. Effect of reducing the n-6/n-3 fatty acid ratio on the maternal and fetal leptin axis in relation to infant body composition. Obesity (Silver Spring). 2014 Jan;22(1):217-24. doi: 10.1002/oby.20481. Epub 2013 Sep 10.
Results Reference
background
PubMed Identifier
23715519
Citation
Much D, Brunner S, Vollhardt C, Schmid D, Sedlmeier EM, Bruderl M, Heimberg E, Bartke N, Boehm G, Bader BL, Amann-Gassner U, Hauner H. Breast milk fatty acid profile in relation to infant growth and body composition: results from the INFAT study. Pediatr Res. 2013 Aug;74(2):230-7. doi: 10.1038/pr.2013.82. Epub 2013 May 28.
Results Reference
background
PubMed Identifier
23909286
Citation
Brunner S, Schmid D, Huttinger K, Much D, Heimberg E, Sedlmeier EM, Bruderl M, Kratzsch J, Bader BL, Amann-Gassner U, Hauner H. Maternal insulin resistance, triglycerides and cord blood insulin in relation to post-natal weight trajectories and body composition in the offspring up to 2 years. Diabet Med. 2013 Dec;30(12):1500-7. doi: 10.1111/dme.12298. Epub 2013 Sep 11.
Results Reference
background
PubMed Identifier
22205307
Citation
Hauner H, Much D, Vollhardt C, Brunner S, Schmid D, Sedlmeier EM, Heimberg E, Schuster T, Zimmermann A, Schneider KT, Bader BL, Amann-Gassner U. Effect of reducing the n-6:n-3 long-chain PUFA ratio during pregnancy and lactation on infant adipose tissue growth within the first year of life: an open-label randomized controlled trial. Am J Clin Nutr. 2012 Feb;95(2):383-94. doi: 10.3945/ajcn.111.022590. Epub 2011 Dec 28.
Results Reference
result
PubMed Identifier
29938825
Citation
Meyer DM, Brei C, Stecher L, Brunner S, Hauner H. Maternal insulin resistance, triglycerides and cord blood insulin are not determinants of offspring growth and adiposity up to 5 years: a follow-up study. Diabet Med. 2018 Oct;35(10):1399-1403. doi: 10.1111/dme.13765. Epub 2018 Aug 2.
Results Reference
derived
PubMed Identifier
27863153
Citation
Meyer DM, Brei C, Stecher L, Much D, Brunner S, Hauner H. The relationship between breast milk leptin and adiponectin with child body composition from 3 to 5 years: a follow-up study. Pediatr Obes. 2017 Aug;12 Suppl 1:125-129. doi: 10.1111/ijpo.12192. Epub 2016 Nov 10.
Results Reference
derived
PubMed Identifier
27053380
Citation
Brei C, Stecher L, Much D, Karla MT, Amann-Gassner U, Shen J, Ganter C, Karampinos DC, Brunner S, Hauner H. Reduction of the n-6:n-3 long-chain PUFA ratio during pregnancy and lactation on offspring body composition: follow-up results from a randomized controlled trial up to 5 y of age. Am J Clin Nutr. 2016 Jun;103(6):1472-81. doi: 10.3945/ajcn.115.128520. Epub 2016 Apr 6.
Results Reference
derived
PubMed Identifier
26053137
Citation
Brei C, Much D, Heimberg E, Schulte V, Brunner S, Stecher L, Vollhardt C, Bauer JS, Amann-Gassner U, Hauner H. Sonographic assessment of abdominal fat distribution during the first year of infancy. Pediatr Res. 2015 Sep;78(3):342-50. doi: 10.1038/pr.2015.108. Epub 2015 Jun 8.
Results Reference
derived
PubMed Identifier
24729519
Citation
Brunner S, Schmid D, Zang K, Much D, Knoeferl B, Kratzsch J, Amann-Gassner U, Bader BL, Hauner H. Breast milk leptin and adiponectin in relation to infant body composition up to 2 years. Pediatr Obes. 2015 Feb;10(1):67-73. doi: 10.1111/j.2047-6310.2014.222.x. Epub 2014 Apr 14.
Results Reference
derived
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Fatty Acids During Pregnancy and Lactation and Body Fat Mass in Newborns
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