The Impact of the Nutritional Fatty Acids During Pregnancy and Lactation for Early Human Adipose Tissue Development
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 208
- 试验地点
- 2
- 主要终点
- amount of fat mass in the offspring
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •High risk pregnancy
- •Hypertonus
- •Chronic diseases (i.e. diabetes mellitus)
- •Psychiatric diseases
- •Former supplementation with LC-PUFA
结局指标
主要结局
amount of fat mass in the offspring
时间窗: at birth, 6 weeks, 4 months, 1 year postpartum
skinfold thickness measurements
次要结局
- amount of fat mass in the offspring(at 1,5 years, 2 years, 2.5 years, 3 years, 4 years and 5 years postpartum (follow-up))
- offspring body height(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(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(15th wk gestation, 32nd wk gestation, 6 weeks pp, 4 months pp)
- fatty acid profile of phospholipids and erythrocyte membrane lipids, fatty acid metabolites(15th wk gestation, 32nd wk gestation, birth, 6 wks, 4 months, 1 year, 3 years postpartum)
- daily intake of maternal fatty acids(15 wks gestation, 32nd wks gestation, 6 wks pp)
- offspring abdominal subcutaneous and preperitoneal fat(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(6 weeks, 4 months, 5 years postpartum)
- maternal and offspring DNA analysis (SNPs, DNA methylation)(15 wk gestation, 32nd wk gestation (maternal), birth, 3 years (offspring))
- epigenetic analyses (histone modification, DNA methylation)(birth)
- cytokines, adipokines and hormone analysis(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(15th wk gestation, 32nd wk gestation (maternal), birth, 4 months, 1 year, 3 years postpartum (offspring))
- metabolomics, lipidomics(15th wk gestation, 32nd wk gestation (maternal), birth, 4 months, 1 year, 3 years postpartum (offspring))
- breast milk oligosaccharides(6 wks and 4 months postpartum)
- offspring atopic eczema(1.5 years - 5 years postpartum)
- offspring allergic diseases (asthma, rhinitis)(5 years postpartum)
- developmental evaluation of children(2 years - 5 years postpartum)
- motor development of children(4 years and 5 years postpartum)
- physical activity of children(2 years - 5 years postpartum)
- maternal and offspring gene expression (mRNA, miRNA)(15 wk gestation, 32nd wk gestation (maternal), birth, 3 years (offspring))
- dietary intake of children(2 years - 5 years postpartum)
- offspring body weight(at birth, 6 weeks, 4 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 4 years and 5 years postpartum)
研究者
Ulrike Amann-Gassner
PhD
Technical University of Munich