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| Name | Class |
|---|---|
| Chalmers University of Technology | OTHER |
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KORN investigates the effects of wholegrain oat and rye intake on health and cognitive wellbeing in children with overweight.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High wholegrain then low wholegrain | Experimental | Starting with high wholegrain intervention followed by low wholegrain intervention |
|
| Low wholegrain then high wholegrain | Experimental | Starting with low wholegrain intervention followed by high wholegrain intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grain products high in wholegrains from oat and rye | Dietary Supplement | A selection of grainproducts high in wholegrain from oat and rye, including cereals, bread, rolls, and pasta is replacing habitual grain products |
| Measure | Description | Time Frame |
|---|---|---|
| Low density lipoprotein cholesterol | by fasting blood sample | 16 weeks |
| Insulin | by fasting blood sample | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Height | by stadiometer | 16 weeks |
| Weight | by digital scale | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary intake | assessed by 4-day dietary record | 16 weeks |
| Physical activity | assessed by questionnaire | 16 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nutrition, Exercise and Sports, University of Copenhagen | Frederiksberg | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37898434 | Derived | Madsen MTB, Landberg R, Nielsen DS, Zhang Y, Anneberg OMR, Lauritzen L, Damsgaard CT. Effects of Wholegrain Compared to Refined Grain Intake on Cardiometabolic Risk Markers, Gut Microbiota, and Gastrointestinal Symptoms in Children: A Randomized Crossover Trial. Am J Clin Nutr. 2024 Jan;119(1):18-28. doi: 10.1016/j.ajcnut.2023.10.025. Epub 2023 Oct 28. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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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.
|
| Grain products low in wholegrains | Dietary Supplement | A selection of grainproducts low in wholegrain, including cereals, bread, rolls, and pasta is replacing habitual grain products |
|
|
| 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 |
| Sociodemographic characteristics | assessed by questionnaire | at baseline |
| Pubertal development stage | assessed by the Tanner scales | at baseline |
| General satisfaction | assessed by questionnaire | 16 weeks |
| Liking of study products | assessed by questionnaire | 16 weeks |
| Alkylresorcinols (compliance) | by fasting blood sample | 16 weeks |
| Android fat mass index | by Dual-energy X-ray Absorptiometry | 16 weeks |
| Gynoid fat mass index | by Dual-energy X-ray Absorptiometry | 16 weeks |
| Android:gynoid fat mass ratio | by Dual-energy X-ray Absorptiometry | 16 weeks |
| Immune cell count | by fasting blood sample | 16 weeks |
| Interleukin 6 (IL-6) | by fasting blood sample | 16 weeks |
| Interleukin 1β (IL-1β) | by fasting blood sample | 16 weeks |
| Tumor necrosis factor alpha (TNFα) | by fasting blood sample | 16 weeks |
| Bone Mineral Density | by Dual-energy X-ray Absorptiometry | 16 weeks |
| Bone Mineral Content | by Dual-energy X-ray Absorptiometry | 16 weeks |
| Bone area | by Dual-energy X-ray Absorptiometry | 16 weeks |
| Gut microbiome composition determined by high throughput sequencing and qPCR | by fecal sample | 16 weeks |
| Short chain fatty acids | by fasting blood sample | 16 weeks |
| Short chain fatty acids | by fecal sample | 16 weeks |
| Bile acids | by fasting blood sample | 16 weeks |
| Bile acids | by fecal sample | 16 weeks |
| Fatty acid composition | by fasting blood sample | 16 weeks |
| C-peptide | by fasting blood sample | 16 weeks |
| Epigenetics | by fasting blood sample | 16 weeks |
| Metabolomics | by fasting blood sample | 16 weeks |
| Metabolomics | by fecal sample | 16 weeks |
| Proteomics | by fasting blood sample | 16 weeks |
| Proteomics | by fecal sample | 16 weeks |
| Genotypes | by fasting blood sample | 16 weeks |
| Adiponectin | by fasting blood sample | 16 weeks |
| Leptin | by fasting blood sample | 16 weeks |
| Appetite hormones | by fasting blood sample | 16 weeks |
| Testosterone | by fasting blood sample | 16 weeks |
| Estrogen | by fasting blood sample | 16 weeks |
| Gonadotropins | by fasting blood sample | 16 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |