Complementary Weaning With Adult Food Typical of the Mediterranean Diet and it Effect on Taste Development and Eating Habits of Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 394
- 主要终点
- Proportions of children showing a good adherence (i.e. KidMed score >= 8) to Mediterranean diet
研究概览
简要总结
A Randomized Controlled Clinical Trials was conducted to study the medium-long term impact of a complementary weaning using adult foods typical of Mediterranean Diets (MD) on children taste development and eating habits, and on the microbiota composition.
Main objectives were to assess the effect of such weaning scheme on:
- medium-long term adherence of the children to the MD (Primary aim).
- familial eating habits to verify how many changes may come from an early education of the kid toward a Mediterranean eating style
- the BMI of the children
- gut microbiota composition
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
- 4 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants, either breast fed or formula fed between 4 and 6 months of age
- •Informed consent from at least one parent
排除标准
- •Infants either with associated comorbidities or with low birth weight
研究组 & 干预措施
Mediterranean Diet group
干预措施: Mediterranean Diet weaning scheme (Dietary Supplement)
Control group
结局指标
主要结局
Proportions of children showing a good adherence (i.e. KidMed score >= 8) to Mediterranean diet
时间窗: 36 months
KidMed is a questionnaire measuring Mediterranean Diet Quality for children and adolescents. The final score ranges from from 0 to 12 where scores \>=8 indicates optimal Mediterranean diet; score within range 4-7 suggest that an improvement is needed to adjust intake to Mediterranean patterns and score \<=3 indicate very low diet quality.
次要结局
- Proportion of overweight and obese children(36 months)
- Variation of microbial communities between arms based on Bray-Curtis dissimilarity(48 months)
- Average of the KidMed score(36 months)
- Average children's BMI(36 months)
研究者
Dario Bruzzese
Full Professor
Federico II University