跳至主要内容
临床试验/NCT05442281
NCT05442281进行中(未招募)不适用

Vegan Diet in Young Children - Studies of Nutritional Intake, Growth and Neurodevelopment

Umeå University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年9月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Staffan Berglund

Senior Consultant, associate professor

Umeå University

研究点 (2)

Loading locations...

相似试验