Effects of Wholegrains on Children's Health (KORN)

Study Overview
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Brief Summary
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KORN investigates the effects of wholegrain oat and rye intake on health and cognitive wellbeing in children with overweight.

Detailed Description
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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.

Official Title
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Effects of Wholegrains on Children's Health (KORN)

Conditions
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Cardiometabolic Health, Gastro-intestinal Wellbeing, Cognitive Function, Overweight

Intervention / Treatment
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* Dietary Supplement: Grain products high in wholegrains from oat and rye
* Dietary Supplement: Grain products low in wholegrains


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High wholegrain then low wholegrain<br>Starting with high wholegrain intervention followed by low wholegrain intervention | Dietary Supplement: Grain products high in wholegrains from oat and rye<br>* A selection of grainproducts high in wholegrain from oat and rye, including cereals, bread, rolls, and pasta is replacing habitual grain products<br>* Other names: Wholegrain;Dietary Supplement: Grain products low in wholegrains<br>* A selection of grainproducts low in wholegrain, including cereals, bread, rolls, and pasta is replacing habitual grain products<br>* Other names: Refined grain;|
| Experimental: Low wholegrain then high wholegrain<br>Starting with low wholegrain intervention followed by high wholegrain intervention | Dietary Supplement: Grain products high in wholegrains from oat and rye<br>* A selection of grainproducts high in wholegrain from oat and rye, including cereals, bread, rolls, and pasta is replacing habitual grain products<br>* Other names: Wholegrain;Dietary Supplement: Grain products low in wholegrains<br>* A selection of grainproducts low in wholegrain, including cereals, bread, rolls, and pasta is replacing habitual grain products<br>* Other names: Refined grain;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low density lipoprotein cholesterol | by fasting blood sample | 16 weeks | 
| Insulin | by fasting blood sample | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height | by stadiometer | 16 weeks | 
| Weight | by digital scale | 16 weeks | 
| Body Mass Index z-score | by height and weight measurements | 16 weeks | 
| Waist circumference | by measuring tape | 16 weeks | 
| Fat mass index | by Dual-energy X-ray Absorptiometry | 16 weeks | 
| Fat free mass index | by Dual-energy X-ray Absorptiometry | 16 weeks | 
| Systolic blood pressure | by digital device | 16 weeks | 
| Diastolic blood pressure | by digital device | 16 weeks | 
| Heart rate | by digital device | 16 weeks | 
| Glucose | by fasting blood sample | 16 weeks | 
| Glycosylated hemoglobin (HbA1c) | by fasting blood sample | 16 weeks | 
| Triacylglycerol | by fasting blood sample | 16 weeks | 
| High density lipoprotein cholesterol | by fasting blood sample | 16 weeks | 
| Total cholesterol | by fasting blood sample | 16 weeks | 
| High sensitivity C-reactive protein | by fasting blood sample | 16 weeks | 
| Attention | assessed by d2 test of attention | 16 weeks | 
| Inhibition | assessed by Stroop color and word test | 16 weeks | 
| Processing speed | assessed by d2 test of attention and Stroop color and word test | 16 weeks | 
| Working memory | assessed by Kim's game | 16 weeks | 
| Socio-emotional skills | assessed by parent reported Strengths and Difficulties Questionnaire | 16 weeks | 
| Stool consistency | assessed by the Bristol stool scale | 16 weeks | 
| Gastrointestinal wellbeing | assessed by questionnaire | 16 weeks | 
| Prevalence of overweight | By the International Obesity Task Force criteria | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Wholegrain, Cardiovascular risk markers, Overweight, Adolescents