Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00362089
Status:
COMPLETED
Last Update Posted:
2014-02-04
First Post:
2006-08-08
Brief Title:
Fatty Acids During Pregnancy and Lactation and Body Fat Mass in Newborns
Sponsor:
Technical University of Munich
Organization:
Technical University of Munich
Study Overview
Official Title:
The Impact of the Nutritional Fatty Acids During Pregnancy and Lactation for Early Human Adipose Tissue Development
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ie DHA and EPA and a resulting lower n-6n-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 ie arachidonic acid stimulate the differentiation of preadipocytes to adipocytes whereas n-3 fatty acids ie 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
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 ie DHA and EPA and a resulting lower n-6n-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 ie arachidonic acid stimulate the differentiation of preadipocytes to adipocytes whereas n-3 fatty acids ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| INFAT | OTHER | Else Kroener-Fresenius-Center for Nutritional Medicine | None |