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| Tracking Information | |||||||||
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| First Received Date ICMJE | August 8, 2006 | ||||||||
| Last Updated Date | January 11, 2007 | ||||||||
| Start Date ICMJE | June 2006 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
body fat mass of newborns | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00362089 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Fatty Acids During Pregnancy and Lactation and Body Fat Mass in Newborns | ||||||||
| Official Title ICMJE | The Impact of the Nutritional Fatty Acids During Pregnancy and Lactation for Early Human Adipose Tissue Development | ||||||||
| 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. |
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| 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. |
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Procedure: Marinol D-40 starting from 15 wk gestation until 4 mo pp | ||||||||
| Study Arms / Comparison Groups | |||||||||
| 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. Epub 2009 Mar 19. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 204 | ||||||||
| Completion Date | August 2009 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 43 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00362089 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | EKFZ001_CN, INFAT | ||||||||
| Study Sponsor ICMJE | Technische Universität München | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Technische Universität München | ||||||||
| Verification Date | January 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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