Effects of Wholegrains on Children's Health (KORN) (NCT04430465) | Clinical Trial Compass
CompletedNot Applicable
Effects of Wholegrains on Children's Health (KORN)
Denmark55 participantsStarted 2020-09-03
Plain-language summary
KORN investigates the effects of wholegrain oat and rye intake on health and cognitive wellbeing in children with overweight.
Who can participate
Age range8 Years – 13 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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