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Effects of Wholegrains on Children's Health (KORN) | Clinical Trials | Clareo Health

COMPLETEDNA

Effects of Wholegrains on Children's Health (KORN)

NCT04430465•University of Copenhagen

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.

Eligibility

Age

8 - 13 years

Sex

ALL

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

Locations (1)

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg, Denmark

Key Dates

Start Date

September 3, 2020

Primary Completion Date

May 4, 2021

Completion Date

May 4, 2021

Last Updated

May 7, 2021

Enrollment

ACTUAL participants

Conditions

Cardiometabolic HealthGastro-intestinal WellbeingCognitive FunctionOverweight

Interventions

Grain products high in wholegrains from oat and rye

DIETARY_SUPPLEMENT

Grain products low in wholegrains

DIETARY_SUPPLEMENT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 7, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effects of Wholegrains on Children's Health (KORN)

Inclusion Criteria

Exclusion Criteria

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