NCT04430465

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 3, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2021

Completed
Last Updated

May 7, 2021

Status Verified

January 1, 2021

Enrollment Period

8 months

First QC Date

June 10, 2020

Last Update Submit

May 6, 2021

Conditions

Cardiometabolic HealthGastro-intestinal WellbeingCognitive FunctionOverweight

Keywords

ChildrenWholegrainCardiovascular risk markersOverweightAdolescents

Outcome Measures

Primary Outcomes (2)

  • Low density lipoprotein cholesterol

    by fasting blood sample

    16 weeks

  • Insulin

    by fasting blood sample

    16 weeks

Secondary Outcomes (23)

  • Height

    16 weeks

  • Weight

    16 weeks

  • Body Mass Index z-score

    16 weeks

  • Waist circumference

    16 weeks

  • Fat mass index

    16 weeks

  • +18 more secondary outcomes

Other Outcomes (36)

  • Dietary intake

    16 weeks

  • Physical activity

    16 weeks

  • Sociodemographic characteristics

    at baseline

  • +33 more other outcomes

Study Arms (2)

High wholegrain then low wholegrain

EXPERIMENTAL

Starting with high wholegrain intervention followed by low wholegrain intervention

Dietary Supplement: Grain products high in wholegrains from oat and ryeDietary Supplement: Grain products low in wholegrains

Low wholegrain then high wholegrain

EXPERIMENTAL

Starting with low wholegrain intervention followed by high wholegrain intervention

Dietary Supplement: Grain products high in wholegrains from oat and ryeDietary Supplement: Grain products low in wholegrains

Interventions

Grain products high in wholegrains from oat and ryeDIETARY_SUPPLEMENT

A selection of grainproducts high in wholegrain from oat and rye, including cereals, bread, rolls, and pasta is replacing habitual grain products

Also known as: Wholegrain
High wholegrain then low wholegrainLow wholegrain then high wholegrain
Grain products low in wholegrainsDIETARY_SUPPLEMENT

A selection of grainproducts low in wholegrain, including cereals, bread, rolls, and pasta is replacing habitual grain products

Also known as: Refined grain
High wholegrain then low wholegrainLow wholegrain then high wholegrain

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg, Denmark

Location

Related Publications (1)

  • Madsen MTB, Landberg R, Nielsen DS, Zhang Y, Anneberg OMR, Lauritzen L, Damsgaard CT. Effects of Wholegrain Compared to Refined Grain Intake on Cardiometabolic Risk Markers, Gut Microbiota, and Gastrointestinal Symptoms in Children: A Randomized Crossover Trial. Am J Clin Nutr. 2024 Jan;119(1):18-28. doi: 10.1016/j.ajcnut.2023.10.025. Epub 2023 Oct 28.

    PMID: 37898434DERIVED

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The intervention and data collection will be conducted unmasked. The data set will be masked before data analysis by staff not involved in the study.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 10, 2020

First Posted

June 12, 2020

Study Start

September 3, 2020

Primary Completion

May 4, 2021

Study Completion

May 4, 2021

Last Updated

May 7, 2021

Record last verified: 2021-01

Locations

DK(1)