Cardiometabolic Health, Cognitive Function, Gastro-intestinal Wellbeing, Overweight
Conditions
Keywords
Children, Wholegrain, Cardiovascular risk markers, Overweight, Adolescents
Brief summary
KORN investigates the effects of wholegrain oat and rye intake on health and cognitive wellbeing in children with overweight.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTGrain products high in wholegrains from oat and rye
A selection of grainproducts high in wholegrain from oat and rye, including cereals, bread, rolls, and pasta is replacing habitual grain products
DIETARY_SUPPLEMENTGrain products low in wholegrains
A selection of grainproducts low in wholegrain, including cereals, bread, rolls, and pasta is replacing habitual grain products
Sponsors
Chalmers University of Technology
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
8 Years to 13 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Low density lipoprotein cholesterol | 16 weeks | by fasting blood sample |
| Insulin | 16 weeks | by fasting blood sample |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| High sensitivity C-reactive protein | 16 weeks | by fasting blood sample |
| Glycosylated hemoglobin (HbA1c) | 16 weeks | by fasting blood sample |
| Attention | 16 weeks | assessed by d2 test of attention |
| Inhibition | 16 weeks | assessed by Stroop color and word test |
| Triacylglycerol | 16 weeks | by fasting blood sample |
| Processing speed | 16 weeks | assessed by d2 test of attention and Stroop color and word test |
| Working memory | 16 weeks | assessed by Kim's game |
| Socio-emotional skills | 16 weeks | assessed by parent reported Strengths and Difficulties Questionnaire |
| Stool consistency | 16 weeks | assessed by the Bristol stool scale |
| Gastrointestinal wellbeing | 16 weeks | assessed by questionnaire |
| High density lipoprotein cholesterol | 16 weeks | by fasting blood sample |
| Height | 16 weeks | by stadiometer |
| Weight | 16 weeks | by digital scale |
| Body Mass Index z-score | 16 weeks | by height and weight measurements |
| Waist circumference | 16 weeks | by measuring tape |
| Fat mass index | 16 weeks | by Dual-energy X-ray Absorptiometry |
| Fat free mass index | 16 weeks | by Dual-energy X-ray Absorptiometry |
| Systolic blood pressure | 16 weeks | by digital device |
| Diastolic blood pressure | 16 weeks | by digital device |
| Heart rate | 16 weeks | by digital device |
| Glucose | 16 weeks | by fasting blood sample |
| Prevalence of overweight | 16 weeks | By the International Obesity Task Force criteria |
| Total cholesterol | 16 weeks | by fasting blood sample |
Other
| Measure | Time frame | Description |
|---|---|---|
| Proteomics | 16 weeks | by fasting blood sample |
| Genotypes | 16 weeks | by fasting blood sample |
| Adiponectin | 16 weeks | by fasting blood sample |
| Leptin | 16 weeks | by fasting blood sample |
| Testosterone | 16 weeks | by fasting blood sample |
| Estrogen | 16 weeks | by fasting blood sample |
| Gonadotropins | 16 weeks | by fasting blood sample |
| Appetite hormones | 16 weeks | by fasting blood sample |
| Dietary intake | 16 weeks | assessed by 4-day dietary record |
| Physical activity | 16 weeks | assessed by questionnaire |
| Sociodemographic characteristics | at baseline | assessed by questionnaire |
| Pubertal development stage | at baseline | assessed by the Tanner scales |
| General satisfaction | 16 weeks | assessed by questionnaire |
| Liking of study products | 16 weeks | assessed by questionnaire |
| Alkylresorcinols (compliance) | 16 weeks | by fasting blood sample |
| Android fat mass index | 16 weeks | by Dual-energy X-ray Absorptiometry |
| Gynoid fat mass index | 16 weeks | by Dual-energy X-ray Absorptiometry |
| Android:gynoid fat mass ratio | 16 weeks | by Dual-energy X-ray Absorptiometry |
| Immune cell count | 16 weeks | by fasting blood sample |
| Interleukin 6 (IL-6) | 16 weeks | by fasting blood sample |
| Interleukin 1β (IL-1β) | 16 weeks | by fasting blood sample |
| Tumor necrosis factor alpha (TNFα) | 16 weeks | by fasting blood sample |
| Bone Mineral Density | 16 weeks | by Dual-energy X-ray Absorptiometry |
| Bone Mineral Content | 16 weeks | by Dual-energy X-ray Absorptiometry |
| Bone area | 16 weeks | by Dual-energy X-ray Absorptiometry |
| Gut microbiome composition determined by high throughput sequencing and qPCR | 16 weeks | by fecal sample |
| Short chain fatty acids | 16 weeks | by fasting blood sample |
| Bile acids | 16 weeks | by fasting blood sample |
| Fatty acid composition | 16 weeks | by fasting blood sample |
| C-peptide | 16 weeks | by fasting blood sample |
| Epigenetics | 16 weeks | by fasting blood sample |
| Metabolomics | 16 weeks | by fasting blood sample |
Countries
Denmark
Outcome results
None listed