Organic Diet in Pregnancy and Risk Markers of Health Effects
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Maternal urinary excretion level of dialkylphosphates
研究概览
简要总结
The OrgDiet project is a two-armed (1:1), open, intention-to-treat randomized controlled trial. The aim is to examine effects of consumption of organic foods (intervention group) vs. conventional foods (control group) during pregnancy in both mother and child. About 100 participants will be included and the participants will be followed until the children are two years old. Both groups will also be recommended to eat according to the dietary guidelines of the Directory of Health in Norway.
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
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Nulli- or multipara pregnant in first trimester
排除标准
- •Consuming an organic diet regularly
- •Using medication regularly that might interfere with study adherence or - outcomes
- •Diagnosed with a chronic disorder or cancer
- •Having a food allergy or intolerance
研究组 & 干预措施
Organic diet
Consuming organic food from the start of 2nd trimester and until gestational week 37.
干预措施: Organic diet (Other)
Conventional diet
Consuming conventional food throughout the whole pregnancy.
干预措施: Conventional diet (Other)
结局指标
主要结局
Maternal urinary excretion level of dialkylphosphates
时间窗: 2.5 years
The difference in maternal urinary excretion level of these pesticides at the end of intervention (gestational week 37) between the intervention group and the control group, measured at baseline (gestational week 12-14), and at several occasions until 2 years after the birth of the baby.
次要结局
- Blood concentration CRP(2.5 years)
- Child body weight(2 years)
- Blood concentration HbA1c(2.5 years)
- Abundance and species-types of gut microbiota (e.g. staphylococci and enterobacter) sampled from stool samples(2.5 years)
- Child body length(2 years)
- DNA methylation patterns in leucocytes as a marker of altered epigenetic programming(2.5 years)
- Blood concentration of cholesterol(2.5 years)
- Child urinary excretion level of dialkylphosphates(2 years)
研究者
Per Ole Iversen, MD
Professor
University of Oslo