Effects of Wholegrains on Children's Health (KORN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Low density lipoprotein cholesterol
研究概览
简要总结
KORN investigates the effects of wholegrain oat and rye intake on health and cognitive wellbeing in children with overweight.
详细描述
The purpose of KORN is to investigate the effects of wholegrain oat and rye intake on cardiometabolic health in slightly overweight 8-13-year-old children. Moreover, KORN aims to investigate effects on body weight and body composition, inflammatory markers, gastrointestinal wellbeing and cognitive function and explore the potential underlying mechanisms through assessment of changes in the children's gut microbiota as well as potential genotype-dependent and sex-specific effects.
The study has a randomized controlled cross-over design. In two 8-week dietary periods the children will receive grain products (cereals, breads, pasta etc) with either high or low content of wholegrain from oat and rye in random order. Measurements and biological sampling will be performed at 0, 8 and 16 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The intervention and data collection will be conducted unmasked. The data set will be masked before data analysis by staff not involved in the study.
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Boys and girls 8-13 years of age
- •Be overweight i.e. have a parent-reported BMI of at least +1 standard deviation above the median according to the age and sex-standardized Danish growth curves
- •Be healthy
- •Like grain products and eat them daily
- •Speak Danish in order to understand the study procedures
- •At least one parent must read and speak Danish, in order to be properly informed about the study procedures
- •Parents must have freezer capacity for 2 weeks bread provision
排除标准
- •Allergy or intolerance to the study foods, including gluten
- •Use of dietary fiber supplements (e.g. HUSK) or probiotic supplements
- •Dieting or on a special diet
- •Serious chronic illnesses and diseases that may interfere with study outcomes
- •Use of medication that may affect study outcomes, including use of antibiotics the last month
- •Concomitant participation in other studies involving dietary supplements, drugs or blood sampling
- •Living in a household with another participating child
结局指标
主要结局
Low density lipoprotein cholesterol
时间窗: 16 weeks
by fasting blood sample
Insulin
时间窗: 16 weeks
by fasting blood sample
次要结局
- Working memory(16 weeks)
- Weight(16 weeks)
- Body Mass Index z-score(16 weeks)
- Height(16 weeks)
- Glucose(16 weeks)
- Diastolic blood pressure(16 weeks)
- Glycosylated hemoglobin (HbA1c)(16 weeks)
- Triacylglycerol(16 weeks)
- Inhibition(16 weeks)
- Fat free mass index(16 weeks)
- High density lipoprotein cholesterol(16 weeks)
- Total cholesterol(16 weeks)
- Attention(16 weeks)
- Fat mass index(16 weeks)
- Systolic blood pressure(16 weeks)
- Heart rate(16 weeks)
- High sensitivity C-reactive protein(16 weeks)
- Processing speed(16 weeks)
- Waist circumference(16 weeks)
- Stool consistency(16 weeks)
- Socio-emotional skills(16 weeks)
- Gastrointestinal wellbeing(16 weeks)
- Prevalence of overweight(16 weeks)
研究者
Camilla Trab Damsgaard
Associate Professor
University of Copenhagen