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Effects of Wholegrains on Children's Health (KORN)

Primary Purpose

Cardiometabolic Health, Gastro-intestinal Wellbeing, Cognitive Function

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Grain products high in wholegrains from oat and rye
Grain products low in wholegrains
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiometabolic Health focused on measuring Children, Wholegrain, Cardiovascular risk markers, Overweight, Adolescents

Eligibility Criteria

8 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Nutrition, Exercise and Sports, University of Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High wholegrain then low wholegrain

Low wholegrain then high wholegrain

Arm Description

Starting with high wholegrain intervention followed by low wholegrain intervention

Starting with low wholegrain intervention followed by high wholegrain intervention

Outcomes

Primary Outcome Measures

Low density lipoprotein cholesterol
by fasting blood sample
Insulin
by fasting blood sample

Secondary Outcome Measures

Height
by stadiometer
Weight
by digital scale
Body Mass Index z-score
by height and weight measurements
Waist circumference
by measuring tape
Fat mass index
by Dual-energy X-ray Absorptiometry
Fat free mass index
by Dual-energy X-ray Absorptiometry
Systolic blood pressure
by digital device
Diastolic blood pressure
by digital device
Heart rate
by digital device
Glucose
by fasting blood sample
Glycosylated hemoglobin (HbA1c)
by fasting blood sample
Triacylglycerol
by fasting blood sample
High density lipoprotein cholesterol
by fasting blood sample
Total cholesterol
by fasting blood sample
High sensitivity C-reactive protein
by fasting blood sample
Attention
assessed by d2 test of attention
Inhibition
assessed by Stroop color and word test
Processing speed
assessed by d2 test of attention and Stroop color and word test
Working memory
assessed by Kim's game
Socio-emotional skills
assessed by parent reported Strengths and Difficulties Questionnaire
Stool consistency
assessed by the Bristol stool scale
Gastrointestinal wellbeing
assessed by questionnaire
Prevalence of overweight
By the International Obesity Task Force criteria

Full Information

First Posted
June 10, 2020
Last Updated
May 6, 2021
Sponsor
University of Copenhagen
Collaborators
Chalmers University of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04430465
Brief Title
Effects of Wholegrains on Children's Health (KORN)
Official Title
Effects of Wholegrains on Children's Health (KORN)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 3, 2020 (Actual)
Primary Completion Date
May 4, 2021 (Actual)
Study Completion Date
May 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Chalmers University of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiometabolic Health, Gastro-intestinal Wellbeing, Cognitive Function, Overweight
Keywords
Children, Wholegrain, Cardiovascular risk markers, Overweight, Adolescents

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High wholegrain then low wholegrain
Arm Type
Experimental
Arm Description
Starting with high wholegrain intervention followed by low wholegrain intervention
Arm Title
Low wholegrain then high wholegrain
Arm Type
Experimental
Arm Description
Starting with low wholegrain intervention followed by high wholegrain intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Grain products high in wholegrains from oat and rye
Other Intervention Name(s)
Wholegrain
Intervention Description
A selection of grainproducts high in wholegrain from oat and rye, including cereals, bread, rolls, and pasta is replacing habitual grain products
Intervention Type
Dietary Supplement
Intervention Name(s)
Grain products low in wholegrains
Other Intervention Name(s)
Refined grain
Intervention Description
A selection of grainproducts low in wholegrain, including cereals, bread, rolls, and pasta is replacing habitual grain products
Primary Outcome Measure Information:
Title
Low density lipoprotein cholesterol
Description
by fasting blood sample
Time Frame
16 weeks
Title
Insulin
Description
by fasting blood sample
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Height
Description
by stadiometer
Time Frame
16 weeks
Title
Weight
Description
by digital scale
Time Frame
16 weeks
Title
Body Mass Index z-score
Description
by height and weight measurements
Time Frame
16 weeks
Title
Waist circumference
Description
by measuring tape
Time Frame
16 weeks
Title
Fat mass index
Description
by Dual-energy X-ray Absorptiometry
Time Frame
16 weeks
Title
Fat free mass index
Description
by Dual-energy X-ray Absorptiometry
Time Frame
16 weeks
Title
Systolic blood pressure
Description
by digital device
Time Frame
16 weeks
Title
Diastolic blood pressure
Description
by digital device
Time Frame
16 weeks
Title
Heart rate
Description
by digital device
Time Frame
16 weeks
Title
Glucose
Description
by fasting blood sample
Time Frame
16 weeks
Title
Glycosylated hemoglobin (HbA1c)
Description
by fasting blood sample
Time Frame
16 weeks
Title
Triacylglycerol
Description
by fasting blood sample
Time Frame
16 weeks
Title
High density lipoprotein cholesterol
Description
by fasting blood sample
Time Frame
16 weeks
Title
Total cholesterol
Description
by fasting blood sample
Time Frame
16 weeks
Title
High sensitivity C-reactive protein
Description
by fasting blood sample
Time Frame
16 weeks
Title
Attention
Description
assessed by d2 test of attention
Time Frame
16 weeks
Title
Inhibition
Description
assessed by Stroop color and word test
Time Frame
16 weeks
Title
Processing speed
Description
assessed by d2 test of attention and Stroop color and word test
Time Frame
16 weeks
Title
Working memory
Description
assessed by Kim's game
Time Frame
16 weeks
Title
Socio-emotional skills
Description
assessed by parent reported Strengths and Difficulties Questionnaire
Time Frame
16 weeks
Title
Stool consistency
Description
assessed by the Bristol stool scale
Time Frame
16 weeks
Title
Gastrointestinal wellbeing
Description
assessed by questionnaire
Time Frame
16 weeks
Title
Prevalence of overweight
Description
By the International Obesity Task Force criteria
Time Frame
16 weeks
Other Pre-specified Outcome Measures:
Title
Dietary intake
Description
assessed by 4-day dietary record
Time Frame
16 weeks
Title
Physical activity
Description
assessed by questionnaire
Time Frame
16 weeks
Title
Sociodemographic characteristics
Description
assessed by questionnaire
Time Frame
at baseline
Title
Pubertal development stage
Description
assessed by the Tanner scales
Time Frame
at baseline
Title
General satisfaction
Description
assessed by questionnaire
Time Frame
16 weeks
Title
Liking of study products
Description
assessed by questionnaire
Time Frame
16 weeks
Title
Alkylresorcinols (compliance)
Description
by fasting blood sample
Time Frame
16 weeks
Title
Android fat mass index
Description
by Dual-energy X-ray Absorptiometry
Time Frame
16 weeks
Title
Gynoid fat mass index
Description
by Dual-energy X-ray Absorptiometry
Time Frame
16 weeks
Title
Android:gynoid fat mass ratio
Description
by Dual-energy X-ray Absorptiometry
Time Frame
16 weeks
Title
Immune cell count
Description
by fasting blood sample
Time Frame
16 weeks
Title
Interleukin 6 (IL-6)
Description
by fasting blood sample
Time Frame
16 weeks
Title
Interleukin 1β (IL-1β)
Description
by fasting blood sample
Time Frame
16 weeks
Title
Tumor necrosis factor alpha (TNFα)
Description
by fasting blood sample
Time Frame
16 weeks
Title
Bone Mineral Density
Description
by Dual-energy X-ray Absorptiometry
Time Frame
16 weeks
Title
Bone Mineral Content
Description
by Dual-energy X-ray Absorptiometry
Time Frame
16 weeks
Title
Bone area
Description
by Dual-energy X-ray Absorptiometry
Time Frame
16 weeks
Title
Gut microbiome composition determined by high throughput sequencing and qPCR
Description
by fecal sample
Time Frame
16 weeks
Title
Short chain fatty acids
Description
by fasting blood sample
Time Frame
16 weeks
Title
Short chain fatty acids
Description
by fecal sample
Time Frame
16 weeks
Title
Bile acids
Description
by fasting blood sample
Time Frame
16 weeks
Title
Bile acids
Description
by fecal sample
Time Frame
16 weeks
Title
Fatty acid composition
Description
by fasting blood sample
Time Frame
16 weeks
Title
C-peptide
Description
by fasting blood sample
Time Frame
16 weeks
Title
Epigenetics
Description
by fasting blood sample
Time Frame
16 weeks
Title
Metabolomics
Description
by fasting blood sample
Time Frame
16 weeks
Title
Metabolomics
Description
by fecal sample
Time Frame
16 weeks
Title
Proteomics
Description
by fasting blood sample
Time Frame
16 weeks
Title
Proteomics
Description
by fecal sample
Time Frame
16 weeks
Title
Genotypes
Description
by fasting blood sample
Time Frame
16 weeks
Title
Adiponectin
Description
by fasting blood sample
Time Frame
16 weeks
Title
Leptin
Description
by fasting blood sample
Time Frame
16 weeks
Title
Appetite hormones
Description
by fasting blood sample
Time Frame
16 weeks
Title
Testosterone
Description
by fasting blood sample
Time Frame
16 weeks
Title
Estrogen
Description
by fasting blood sample
Time Frame
16 weeks
Title
Gonadotropins
Description
by fasting blood sample
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Nutrition, Exercise and Sports, University of Copenhagen
City
Frederiksberg
Country
Denmark

12. IPD Sharing Statement

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Effects of Wholegrains on Children's Health (KORN)

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