Effect of Mediterranean Diet During Pregnancy on the Onset of Overweight and Obesity at 24 Months in the Offspring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The effects of Mediterranean Diet in pregnancy on the occurrence of overweight/obesity at 24 months in the offspring
研究概览
简要总结
The first 1,000 days of life, from the conception to 24 months, are crucial to achieve long-term health outcomes and represent a strategic period to intervene under prevention and public health perspective. Nutritional exposures during this critical period of life can influence the future disease susceptibility. Maternal diet during pregnancy has been linked to offspring overweight/obesity risk and it could represent a potential target for overweight/obesity prevention. The Mediterranean Diet (MD) is considered one of the healthiest dietary models, which impacts beneficially the gut microbiome (GM), providing high amounts of fiber, antioxidants polyphenols and vitamins, and a balanced ratio of essential fatty acids (ω6:ω3). Notably, the MD beneficial effects are due to the synergistic and interactive combinations of nutrients, and the modulation of gene expression through epigenetic changes. Unofrtunately, the MD mechanisms during pregnancy in the prevention of childhood overweight/obesity are not yet fully known.
详细描述
The PREMEDI study has been designed to evaluate the effects of Mediterranean Diet during pregnancy on the occurrence of overweight/obesity at 24 months in the offspring.
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
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •caucasian ethnicity
- •aged between 20 and 35 years
排除标准
- •proven presence of infections during pregnancy and at delivery,
- •twin pregnancy,
- •ongoing malignancies,
- •major gastrointestinal tract malformations,
- •immunodeficiencies,
- •diabetes and other chronic diseases at each organ or apparatus level,
- •chronic intestinal inflammatory diseases,
- •gastrointestinal function disorders,
- •celiac disease;
- •history of abdominal surgery with intestinal resection,
- •neuropsychiatric disorders,
- •central nervous system disorders,
- •vegan diet.
结局指标
主要结局
The effects of Mediterranean Diet in pregnancy on the occurrence of overweight/obesity at 24 months in the offspring
时间窗: After 24 months from the delivery
The children body growth indices are evaluated at 24 months
次要结局
- The effect of Mediterranean Diet pregnancy on the composition of maternal gut microbiota through analysis of gut microbiota composition.(after 9 months (at the end of the pregnancy))
- The effect of Mediterranean diet in pregnancy on the production of short chain fatty acids (butyrate and propionate) in the intestinal tract.(after 9 months (at the end of the pregnancy))
- The adherence to Mediterranean Diet in the enrolled women(from 0 to 9 months (at the end of pregnancy))
- The effect of dietary counseling on dietary habits(from 0 to 9 months (at the end of pregnancy))
- The effect of Mediterranean diet in pregnancy on the maternal weight gain and complications(from 0 to 9 months (at the end of pregnancy))
- The effect of Mediterranean diet in pregnancy on perinatal and fetal complications(from 0 to 9 months (at the end of pregnancy))
- The effect of Mediterranean Diet in pregnancy on the duration of breastfeeding and the composition of breast milk(from 0 to 4 months lactation)
- The effect of Mediterranean Diet on the epigenetic modulation of genes involved in the regulation of immune system and metabolic pathways in the offspring(At delivery)
- The effect of Mediterranean Diet on the occurrence of allergies and use of antibiotics in the first 2 years of life.(Every 6 months from offspring birth to 2 years)
研究者
Roberto Berni Canani, MD, PhD
MD, PhD
Federico II University