Clinical Trials Directory

Trials / Completed

CompletedNCT04430465

Effects of Wholegrains on Children's Health (KORN)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
55 (actual)
Sponsor
University of Copenhagen · Academic / Other
Sex
All
Age
8 Years – 13 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTGrain products high in wholegrains from oat and ryeA 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 wholegrainsA selection of grainproducts low in wholegrain, including cereals, bread, rolls, and pasta is replacing habitual grain products

Timeline

Start date
2020-09-03
Primary completion
2021-05-04
Completion
2021-05-04
First posted
2020-06-12
Last updated
2021-05-07

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT04430465. Inclusion in this directory is not an endorsement.