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
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Grain products high in wholegrains from oat and rye | A selection of grainproducts high in wholegrain from oat and rye, including cereals, bread, rolls, and pasta is replacing habitual grain products |
| DIETARY_SUPPLEMENT | Grain products low in wholegrains | A 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.