Vegan Diet in Young Children - Studies of Nutritional Intake, Growth and Neurodevelopment
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Concentration of Hemoglobin
研究概览
简要总结
Following increased knowledge about climate change and how food production affects greenhouse gas emissions, the interest in vegetarian diets is increasing. In line with this, also vegan diet is becoming more common at all ages, including in young children. But the state of knowledge regarding the effect of this diet on children during infancy and early childhood has been poorly studied and existing literature consists to a large extent of case reports.
With the main hypothesis that vegan diet from the introduction of complementary foods causes reduced bio availability of certain micronutrients important for development, the aim of this study is to examine dietary intake and development during the first years of life in a group of children eating vegan diet and compare with a reference group eating mixed diets.
In an observational study, investigators plan to include 30 children before the age of 6 months during the years 2021-2026, where the parents have decided to offer their child only vegan food. The children are studied in comparison with a reference group of 30 matched cases regarding growth, nutritional status, and dietary intake. Data collection includes monthly dietary records and blood sample analyses and growth at 6, 12 and 24 months. At the age of 3, cognitive developmental assessment (WPSSI-IV) and an DEXA examination of body composition are performed.
The study is expected to contribute to increased knowledge about the risk and benefits of vegan diets and thereby provide a better basis for future recommendations.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Months 至 8 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Planned exclusive vegan diet or mixed diet respectively from 6 months of age until at least 2 years of life
- •Exclusively (>90%) breastfed until 4 months
- •Born term (GE 37+0 - 41+6)
- •Single birth
- •Birth weight >2500 g
- •Apgar score 5 min > 5
排除标准
- •* A chronic disease affecting growth or neurodevelopment
结局指标
主要结局
Concentration of Hemoglobin
时间窗: 12 months of age
Blood
Body Weight (kg)
时间窗: 12 months of age
measured weight at 12 mo using a device for measuring weight
次要结局
- Zink level(6, 12, 24, 36 months)
- D-vitamin levels(6, 12, 24, 36 months)
- Fat mass index(3 years of age)
- Transferrin saturation(12 months of age)
- Wechsler Preschool & Primary Scale of Intelligence(3 years of age)
- Protein intake(at 12 months of age)
- B12 levels(6, 12, 24, 36 months)
- Calcium levels(6, 12, 24, 36 months)
- Homocysteine levels(6, 12, 24, 36 months)
- Circumference of the head(12 months of age)
- Lean mass index(3 years of age)
- Fat intake(at 12 months of age)
- Iron intake (mg/day)(throughout study)
- Transferrin receptor concentration(12 months of age)
- Length of body(12 months of age)
- Carbohydrate intake(at 12 months of age)
- Mean cell volume(12 months of age)
- Ferritin(12 months of age)
研究者
Staffan Berglund
Senior Consultant, associate professor
Umeå University
