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Completed

NCT Number: NCT04430465

Effects of Wholegrains on Children's Health (KORN)

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

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Key information

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Wholegrain

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

Other names: Refined grain

Primary outcomes

  1. Low density lipoprotein cholesterol

    Time frame: 16 weeks

    by fasting blood sample

  2. Insulin

    Time frame: 16 weeks

    by fasting blood sample

Secondary outcomes

  1. Height

    Time frame: 16 weeks

    by stadiometer

  2. Weight

    Time frame: 16 weeks

    by digital scale

  3. Body Mass Index z-score

    Time frame: 16 weeks

    by height and weight measurements

  4. Waist circumference

    Time frame: 16 weeks

    by measuring tape

  5. Fat mass index

    Time frame: 16 weeks

    by Dual-energy X-ray Absorptiometry

  6. Fat free mass index

    Time frame: 16 weeks

    by Dual-energy X-ray Absorptiometry

  7. Systolic blood pressure

    Time frame: 16 weeks

    by digital device

  8. Diastolic blood pressure

    Time frame: 16 weeks

    by digital device

  9. Heart rate

    Time frame: 16 weeks

    by digital device

  10. Glucose

    Time frame: 16 weeks

    by fasting blood sample

  11. Glycosylated hemoglobin (HbA1c)

    Time frame: 16 weeks

    by fasting blood sample

  12. Triacylglycerol

    Time frame: 16 weeks

    by fasting blood sample

  13. High density lipoprotein cholesterol

    Time frame: 16 weeks

    by fasting blood sample

  14. Total cholesterol

    Time frame: 16 weeks

    by fasting blood sample

  15. High sensitivity C-reactive protein

    Time frame: 16 weeks

    by fasting blood sample

  16. Attention

    Time frame: 16 weeks

    assessed by d2 test of attention

  17. Inhibition

    Time frame: 16 weeks

    assessed by Stroop color and word test

  18. Processing speed

    Time frame: 16 weeks

    assessed by d2 test of attention and Stroop color and word test

  19. Working memory

    Time frame: 16 weeks

    assessed by Kim's game

  20. Socio-emotional skills

    Time frame: 16 weeks

    assessed by parent reported Strengths and Difficulties Questionnaire

  21. Stool consistency

    Time frame: 16 weeks

    assessed by the Bristol stool scale

  22. Gastrointestinal wellbeing

    Time frame: 16 weeks

    assessed by questionnaire

  23. Prevalence of overweight

    Time frame: 16 weeks

    By the International Obesity Task Force criteria

Other outcomes

  1. Dietary intake

    Time frame: 16 weeks

    assessed by 4-day dietary record

  2. Physical activity

    Time frame: 16 weeks

    assessed by questionnaire

  3. Sociodemographic characteristics

    Time frame: at baseline

    assessed by questionnaire

  4. Pubertal development stage

    Time frame: at baseline

    assessed by the Tanner scales

  5. General satisfaction

    Time frame: 16 weeks

    assessed by questionnaire

  6. Liking of study products

    Time frame: 16 weeks

    assessed by questionnaire

  7. Alkylresorcinols (compliance)

    Time frame: 16 weeks

    by fasting blood sample

  8. Android fat mass index

    Time frame: 16 weeks

    by Dual-energy X-ray Absorptiometry

  9. Gynoid fat mass index

    Time frame: 16 weeks

    by Dual-energy X-ray Absorptiometry

  10. Android:gynoid fat mass ratio

    Time frame: 16 weeks

    by Dual-energy X-ray Absorptiometry

  11. Immune cell count

    Time frame: 16 weeks

    by fasting blood sample

  12. Interleukin 6 (IL-6)

    Time frame: 16 weeks

    by fasting blood sample

  13. Interleukin 1β (IL-1β)

    Time frame: 16 weeks

    by fasting blood sample

  14. Tumor necrosis factor alpha (TNFα)

    Time frame: 16 weeks

    by fasting blood sample

  15. Bone Mineral Density

    Time frame: 16 weeks

    by Dual-energy X-ray Absorptiometry

  16. Bone Mineral Content

    Time frame: 16 weeks

    by Dual-energy X-ray Absorptiometry

  17. Bone area

    Time frame: 16 weeks

    by Dual-energy X-ray Absorptiometry

  18. Gut microbiome composition determined by high throughput sequencing and qPCR

    Time frame: 16 weeks

    by fecal sample

  19. Short chain fatty acids

    Time frame: 16 weeks

    by fasting blood sample

  20. Short chain fatty acids

    Time frame: 16 weeks

    by fecal sample

  21. Bile acids

    Time frame: 16 weeks

    by fasting blood sample

  22. Bile acids

    Time frame: 16 weeks

    by fecal sample

  23. Fatty acid composition

    Time frame: 16 weeks

    by fasting blood sample

  24. C-peptide

    Time frame: 16 weeks

    by fasting blood sample

  25. Epigenetics

    Time frame: 16 weeks

    by fasting blood sample

  26. Metabolomics

    Time frame: 16 weeks

    by fasting blood sample

  27. Metabolomics

    Time frame: 16 weeks

    by fecal sample

  28. Proteomics

    Time frame: 16 weeks

    by fasting blood sample

  29. Proteomics

    Time frame: 16 weeks

    by fecal sample

  30. Genotypes

    Time frame: 16 weeks

    by fasting blood sample

  31. Adiponectin

    Time frame: 16 weeks

    by fasting blood sample

  32. Leptin

    Time frame: 16 weeks

    by fasting blood sample

  33. Appetite hormones

    Time frame: 16 weeks

    by fasting blood sample

  34. Testosterone

    Time frame: 16 weeks

    by fasting blood sample

  35. Estrogen

    Time frame: 16 weeks

    by fasting blood sample

  36. Gonadotropins

    Time frame: 16 weeks

    by fasting blood sample

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Chalmers University of Technology

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 12, 2020
Registry last updated
May 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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