Department of Nutrition, Exercise and Sports, University of Copenhagen
Frederiksberg, Denmark
NCT Number: NCT04430465
KORN investigates the effects of wholegrain oat and rye intake on health and cognitive wellbeing in children with overweight.
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Notify Me8 year–13 year
All sexes
Interventional
Not applicable
Frederiksberg, Denmark
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A selection of grainproducts high in wholegrain from oat and rye, including cereals, bread, rolls, and pasta is replacing habitual grain products
Other names: Wholegrain
A selection of grainproducts low in wholegrain, including cereals, bread, rolls, and pasta is replacing habitual grain products
Other names: Refined grain
Time frame: 16 weeks
by fasting blood sample
Time frame: 16 weeks
by fasting blood sample
Time frame: 16 weeks
by stadiometer
Time frame: 16 weeks
by digital scale
Time frame: 16 weeks
by height and weight measurements
Time frame: 16 weeks
by measuring tape
Time frame: 16 weeks
by Dual-energy X-ray Absorptiometry
Time frame: 16 weeks
by Dual-energy X-ray Absorptiometry
Time frame: 16 weeks
by digital device
Time frame: 16 weeks
by digital device
Time frame: 16 weeks
by digital device
Time frame: 16 weeks
by fasting blood sample
Time frame: 16 weeks
by fasting blood sample
Time frame: 16 weeks
by fasting blood sample
Time frame: 16 weeks
by fasting blood sample
Time frame: 16 weeks
by fasting blood sample
Time frame: 16 weeks
by fasting blood sample
Time frame: 16 weeks
assessed by d2 test of attention
Time frame: 16 weeks
assessed by Stroop color and word test
Time frame: 16 weeks
assessed by d2 test of attention and Stroop color and word test
Time frame: 16 weeks
assessed by Kim's game
Time frame: 16 weeks
assessed by parent reported Strengths and Difficulties Questionnaire
Time frame: 16 weeks
assessed by the Bristol stool scale
Time frame: 16 weeks
assessed by questionnaire
Time frame: 16 weeks
By the International Obesity Task Force criteria
Time frame: 16 weeks
assessed by 4-day dietary record
Time frame: 16 weeks
assessed by questionnaire
Time frame: at baseline
assessed by questionnaire
Time frame: at baseline
assessed by the Tanner scales
Time frame: 16 weeks
assessed by questionnaire
Time frame: 16 weeks
assessed by questionnaire
Time frame: 16 weeks
by fasting blood sample
Time frame: 16 weeks
by Dual-energy X-ray Absorptiometry
Time frame: 16 weeks
by Dual-energy X-ray Absorptiometry
Time frame: 16 weeks
by Dual-energy X-ray Absorptiometry
Time frame: 16 weeks
by fasting blood sample
Time frame: 16 weeks
by fasting blood sample
Time frame: 16 weeks
by fasting blood sample
Time frame: 16 weeks
by fasting blood sample
Time frame: 16 weeks
by Dual-energy X-ray Absorptiometry
Time frame: 16 weeks
by Dual-energy X-ray Absorptiometry
Time frame: 16 weeks
by Dual-energy X-ray Absorptiometry
Time frame: 16 weeks
by fecal sample
Time frame: 16 weeks
by fasting blood sample
Time frame: 16 weeks
by fecal sample
Time frame: 16 weeks
by fasting blood sample
Time frame: 16 weeks
by fecal sample
Time frame: 16 weeks
by fasting blood sample
Time frame: 16 weeks
by fasting blood sample
Time frame: 16 weeks
by fasting blood sample
Time frame: 16 weeks
by fasting blood sample
Time frame: 16 weeks
by fecal sample
Time frame: 16 weeks
by fasting blood sample
Time frame: 16 weeks
by fecal sample
Time frame: 16 weeks
by fasting blood sample
Time frame: 16 weeks
by fasting blood sample
Time frame: 16 weeks
by fasting blood sample
Time frame: 16 weeks
by fasting blood sample
Time frame: 16 weeks
by fasting blood sample
Time frame: 16 weeks
by fasting blood sample
Time frame: 16 weeks
by fasting blood sample
University of Copenhagen
Other
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