OverweightNCT00362089
Fatty Acids During Pregnancy and Lactation and Body Fat Mass in Newborns
A study testing Marinol D-40 in people with Overweight and Obesity, run by Technical University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Marinol D-40
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2006to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- High risk pregnancy
- Hypertonus
- Chronic diseases (i.e. diabetes mellitus)
- Psychiatric diseases
- Former supplementation with LC-PUFA
Trial locations and contacts
1 site in 1 country.
Germany1 site
Else Kröner-Fresenius-Zentrum für Ernährungsmedizin, Technische Universität München
Munich, 81675
About this study
Official title: The Impact of the Nutritional Fatty Acids During Pregnancy and Lactation for Early Human Adipose Tissue Development
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.
Read the 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.
- Conditions
- Overweight, Obesity
- Being tested
- Marinol D-40
- 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
- Medical subject headings
- Overweight, Obesity, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marinol D-40Dietary supplement
Marinol D-40, three capsules per day, from 15th week of gestation until 4th month of lactation
| Study group | Role | What they receive |
|---|---|---|
| Marinol | Active comparator | Intervention group with Marinol D40 fish oil capsules Receives: Dietary Supplement: Marinol D-40 |
| Nutrition counseling | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of fat mass in the offspring
skinfold thickness measurements
Measured: at birth, 6 weeks, 4 months, 1 year postpartum
Secondary outcomes (22)
amount of fat mass in the offspring
skinfold thickness measurements
Measured: at 1,5 years, 2 years, 2.5 years, 3 years, 4 years and 5 years postpartum (follow-up)
offspring body height
Measured: at birth, 6 weeks, 4 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 4 years and 5 years postpartum
head circumference of newborns, infants and children
Measured: at birth, 6 weeks, 4 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 4 years and 5 years postpartum
blood lipids of pregnant and lactating women
Measured: 15th wk gestation, 32nd wk gestation, 6 weeks pp, 4 months pp
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
Measured: 15th wk gestation, 32nd wk gestation, birth, 6 wks, 4 months, 1 year, 3 years postpartum
daily intake of maternal fatty acids
7 day dietary records
Measured: 15 wks gestation, 32nd wks gestation, 6 wks pp
offspring abdominal subcutaneous and preperitoneal fat
Ultrasonography
Measured: 6 weeks, 4 months , 1 year , 1.5 years , 2 years, 2.5 years, 3 years, 4 years, 5 years postpartum
offspring fat mass, abdominal fat
magnetic resonance imaging
Measured: 6 weeks, 4 months, 5 years postpartum
maternal and offspring gene expression (mRNA, miRNA)
placenta, umbilical cord tissue, white blood cells, blood plasma
Measured: 15 wk gestation, 32nd wk gestation (maternal), birth, 3 years (offspring)
maternal and offspring DNA analysis (SNPs, DNA methylation)
placenta, umbilical cord tissue, white blood cells
Measured: 15 wk gestation, 32nd wk gestation (maternal), birth, 3 years (offspring)
epigenetic analyses (histone modification, DNA methylation)
placenta, umbilical cord tissue, white blood cells
Measured: birth
cytokines, adipokines and hormone analysis
maternal and offspring blood cells and plasma, placenta, umbilical cord blood cells and plasma, breast milk
Measured: 15th wk gestation, 32nd wk gestation, 6 wks pp, 4 months pp (maternal), birth, 4 months, 1 year, 3 years postpartum (offspring)
protein analysis, proteomics
maternal and offspring blood cells and plasma, placenta, umbilical cord blood cells and plasma
Measured: 15th wk gestation, 32nd wk gestation (maternal), birth, 4 months, 1 year, 3 years postpartum (offspring)
metabolomics, lipidomics
maternal and offspring blood cells and plasma, placenta, umbilical cord blood cells and plasma
Measured: 15th wk gestation, 32nd wk gestation (maternal), birth, 4 months, 1 year, 3 years postpartum (offspring)
breast milk oligosaccharides
Measured: 6 wks and 4 months postpartum
offspring atopic eczema
parent questionnaire
Measured: 1.5 years - 5 years postpartum
offspring allergic diseases (asthma, rhinitis)
parent questionnaire
Measured: 5 years postpartum
developmental evaluation of children
parent questionnaire (based on Minnesota Scales)
Measured: 2 years - 5 years postpartum
motor development of children
Measured: 4 years and 5 years postpartum
physical activity of children
parent questionnaire
Measured: 2 years - 5 years postpartum
dietary intake of children
3 day dietary record
Measured: 2 years - 5 years postpartum
offspring body weight
Measured: at birth, 6 weeks, 4 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 4 years and 5 years postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2006 (estimated)
- Study startJun 2006
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Else Kröner-Fresenius-Foundation; International Unilever-Foundation; Danone Research, EU funding by EARNEST consortium;German Ministry of Education and Research GF-GFGI01120708)
- Responsible party
- Principal investigator, Ulrike Amann-Gassner, Technical University of Munich
- Investigators
- Hans Hauner, Prof., Principal investigator, Else Kröner-Fresenius-Zentrum für Ernährungsmedizin, Technische Universität München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00362089
- Sponsor's protocol ID
- EKFZ001_CN
- Other IDs
- INFAT
- Status last verified
- Feb 2014
- First submitted
- 8 Aug 2006
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19295192Much 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.
PubMed 23340492Brunner 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.
PubMed 23596009Much 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.
PubMed 23715519Brunner 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.
PubMed 23909286Hauner 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.
PubMed 22205307Meyer 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.
PubMed 29938825Meyer 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.
PubMed 27863153Brei 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.
PubMed 27053380Brei 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.
PubMed 26053137Brunner 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.
PubMed 24729519
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Nutritional Fatty Acids During Pregnancy and Lactation for Early Human Adipose Tissue Development
- ClinicalTrials.gov ID
- NCT00362089
- Acronym / sponsor ID
- EKFZ001_CN
- Conditions
- Overweight, Obesity
- Keywords
- n-3 fatty acids, n-6 fatty acids, long chain polyunsaturated fatty acids, pregnancy, lactation, breast feeding, breast milk, adipose tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Else Kröner-Fresenius-Foundation; International Unilever-Foundation; Danone Research, EU funding by EARNEST consortium;German Ministry of Education and Research GF-GFGI01120708)
- Study start
- Jun 2006
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 9 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Marinol | Active comparator | Dietary Supplement: Marinol D-40Intervention group with Marinol D40 fish oil capsules |
| Nutrition counseling | No intervention | –Control group |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- High risk pregnancy
- Hypertonus
- Chronic diseases (i.e. diabetes mellitus)
- Psychiatric diseases
- Former supplementation with LC-PUFA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Marinol D-40Marinol D-40, three capsules per day, from 15th week of gestation until 4th month of lactation | Dietary supplement | Marinol |
Primary outcome
amount of fat mass in the offspring
Time frame: at birth, 6 weeks, 4 months, 1 year postpartum
skinfold thickness measurements
22 secondary outcomes
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)
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
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
blood lipids of pregnant and lactating women
Time frame: 15th wk gestation, 32nd wk gestation, 6 weeks pp, 4 months pp
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
daily intake of maternal fatty acids
Time frame: 15 wks gestation, 32nd wks gestation, 6 wks pp
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
offspring fat mass, abdominal fat
Time frame: 6 weeks, 4 months, 5 years postpartum
maternal and offspring gene expression (mRNA, miRNA)
Time frame: 15 wk gestation, 32nd wk gestation (maternal), birth, 3 years (offspring)
maternal and offspring DNA analysis (SNPs, DNA methylation)
Time frame: 15 wk gestation, 32nd wk gestation (maternal), birth, 3 years (offspring)
epigenetic analyses (histone modification, DNA methylation)
Time frame: birth
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)
protein analysis, proteomics
Time frame: 15th wk gestation, 32nd wk gestation (maternal), birth, 4 months, 1 year, 3 years postpartum (offspring)
metabolomics, lipidomics
Time frame: 15th wk gestation, 32nd wk gestation (maternal), birth, 4 months, 1 year, 3 years postpartum (offspring)
breast milk oligosaccharides
Time frame: 6 wks and 4 months postpartum
offspring atopic eczema
Time frame: 1.5 years - 5 years postpartum
offspring allergic diseases (asthma, rhinitis)
Time frame: 5 years postpartum
developmental evaluation of children
Time frame: 2 years - 5 years postpartum
motor development of children
Time frame: 4 years and 5 years postpartum
physical activity of children
Time frame: 2 years - 5 years postpartum
dietary intake of children
Time frame: 2 years - 5 years postpartum
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2014.
- Background: PubMed 19295192Hauner 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.
- Background: PubMed 23340492Much 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.
- Background: PubMed 23596009Brunner 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.
- Background: PubMed 23715519Much 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.
- Background: PubMed 23909286Brunner 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 publication: PubMed 22205307Hauner 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.
- Derived from this study: PubMed 29938825Meyer 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.
- Derived from this study: PubMed 27863153Meyer 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.
- Derived from this study: PubMed 27053380Brei 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.
- Derived from this study: PubMed 26053137Brei 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.
- Derived from this study: PubMed 24729519Brunner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Hauner, Prof. principal investigator
Else Kröner-Fresenius-Zentrum für Ernährungsmedizin, Technische Universität München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Marinol D-40 in people with Overweight and Obesity, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amount of fat mass in the offspring (time frame: at birth, 6 weeks, 4 months, 1 year postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00362089, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2014.