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| Sponsor: | Technische Universität München |
|---|---|
| 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 |
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 |
|---|---|
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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 |
| 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 |
|---|---|
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Active Comparator: Marinol
Intervention group with Marinol D40 fish oil capsules
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Dietary Supplement: Marinol D-40
Marinol D-40, three capsules per day, from 15th week of gestation until 4th month of lactation
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No Intervention: Nutrition counseling
Control group
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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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany | |
| Else Kröner-Fresenius-Zentrum für Ernährungsmedizin, Technische Universität München | |
| Munich, Germany, 81675 | |
| Principal Investigator: | Hans Hauner, Prof. | Else Kröner-Fresenius-Zentrum für Ernährungsmedizin, Technische Universität München |
More Information
| 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: | January 13, 2012 |
| Health Authority: | Germany: Ethics Commission |
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n-3 fatty acids n-6 fatty acids long chain polyunsaturated fatty acids pregnancy lactation |
breast feeding breast milk adipose tissue newborn fetal development |
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Obesity Overweight Overnutrition Nutrition Disorders Body Weight Signs and Symptoms Tetrahydrocannabinol Hallucinogens Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
