Effects of Wholegrains on Children's Health (KORN)

May 6, 2021 updated by: Camilla Trab Damsgaard, University of Copenhagen
KORN investigates the effects of wholegrain oat and rye intake on health and cognitive wellbeing in children with overweight.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Frederiksberg, Denmark
        • Department of Nutrition, Exercise and sports, University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 13 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High wholegrain then low wholegrain
Starting with high wholegrain intervention followed by low wholegrain intervention
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
Other Names:
  • Wholegrain
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
Other Names:
  • Refined grain
Experimental: Low wholegrain then high wholegrain
Starting with low wholegrain intervention followed by high wholegrain intervention
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
Other Names:
  • Wholegrain
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
Other Names:
  • Refined grain

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Low density lipoprotein cholesterol
Time Frame: 16 weeks
by fasting blood sample
16 weeks
Insulin
Time Frame: 16 weeks
by fasting blood sample
16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Height
Time Frame: 16 weeks
by stadiometer
16 weeks
Weight
Time Frame: 16 weeks
by digital scale
16 weeks
Body Mass Index z-score
Time Frame: 16 weeks
by height and weight measurements
16 weeks
Waist circumference
Time Frame: 16 weeks
by measuring tape
16 weeks
Fat mass index
Time Frame: 16 weeks
by Dual-energy X-ray Absorptiometry
16 weeks
Fat free mass index
Time Frame: 16 weeks
by Dual-energy X-ray Absorptiometry
16 weeks
Systolic blood pressure
Time Frame: 16 weeks
by digital device
16 weeks
Diastolic blood pressure
Time Frame: 16 weeks
by digital device
16 weeks
Heart rate
Time Frame: 16 weeks
by digital device
16 weeks
Glucose
Time Frame: 16 weeks
by fasting blood sample
16 weeks
Glycosylated hemoglobin (HbA1c)
Time Frame: 16 weeks
by fasting blood sample
16 weeks
Triacylglycerol
Time Frame: 16 weeks
by fasting blood sample
16 weeks
High density lipoprotein cholesterol
Time Frame: 16 weeks
by fasting blood sample
16 weeks
Total cholesterol
Time Frame: 16 weeks
by fasting blood sample
16 weeks
High sensitivity C-reactive protein
Time Frame: 16 weeks
by fasting blood sample
16 weeks
Attention
Time Frame: 16 weeks
assessed by d2 test of attention
16 weeks
Inhibition
Time Frame: 16 weeks
assessed by Stroop color and word test
16 weeks
Processing speed
Time Frame: 16 weeks
assessed by d2 test of attention and Stroop color and word test
16 weeks
Working memory
Time Frame: 16 weeks
assessed by Kim's game
16 weeks
Socio-emotional skills
Time Frame: 16 weeks
assessed by parent reported Strengths and Difficulties Questionnaire
16 weeks
Stool consistency
Time Frame: 16 weeks
assessed by the Bristol stool scale
16 weeks
Gastrointestinal wellbeing
Time Frame: 16 weeks
assessed by questionnaire
16 weeks
Prevalence of overweight
Time Frame: 16 weeks
By the International Obesity Task Force criteria
16 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dietary intake
Time Frame: 16 weeks
assessed by 4-day dietary record
16 weeks
Physical activity
Time Frame: 16 weeks
assessed by questionnaire
16 weeks
Sociodemographic characteristics
Time Frame: at baseline
assessed by questionnaire
at baseline
Pubertal development stage
Time Frame: at baseline
assessed by the Tanner scales
at baseline
General satisfaction
Time Frame: 16 weeks
assessed by questionnaire
16 weeks
Liking of study products
Time Frame: 16 weeks
assessed by questionnaire
16 weeks
Alkylresorcinols (compliance)
Time Frame: 16 weeks
by fasting blood sample
16 weeks
Android fat mass index
Time Frame: 16 weeks
by Dual-energy X-ray Absorptiometry
16 weeks
Gynoid fat mass index
Time Frame: 16 weeks
by Dual-energy X-ray Absorptiometry
16 weeks
Android:gynoid fat mass ratio
Time Frame: 16 weeks
by Dual-energy X-ray Absorptiometry
16 weeks
Immune cell count
Time Frame: 16 weeks
by fasting blood sample
16 weeks
Interleukin 6 (IL-6)
Time Frame: 16 weeks
by fasting blood sample
16 weeks
Interleukin 1β (IL-1β)
Time Frame: 16 weeks
by fasting blood sample
16 weeks
Tumor necrosis factor alpha (TNFα)
Time Frame: 16 weeks
by fasting blood sample
16 weeks
Bone Mineral Density
Time Frame: 16 weeks
by Dual-energy X-ray Absorptiometry
16 weeks
Bone Mineral Content
Time Frame: 16 weeks
by Dual-energy X-ray Absorptiometry
16 weeks
Bone area
Time Frame: 16 weeks
by Dual-energy X-ray Absorptiometry
16 weeks
Gut microbiome composition determined by high throughput sequencing and qPCR
Time Frame: 16 weeks
by fecal sample
16 weeks
Short chain fatty acids
Time Frame: 16 weeks
by fasting blood sample
16 weeks
Short chain fatty acids
Time Frame: 16 weeks
by fecal sample
16 weeks
Bile acids
Time Frame: 16 weeks
by fasting blood sample
16 weeks
Bile acids
Time Frame: 16 weeks
by fecal sample
16 weeks
Fatty acid composition
Time Frame: 16 weeks
by fasting blood sample
16 weeks
C-peptide
Time Frame: 16 weeks
by fasting blood sample
16 weeks
Epigenetics
Time Frame: 16 weeks
by fasting blood sample
16 weeks
Metabolomics
Time Frame: 16 weeks
by fasting blood sample
16 weeks
Metabolomics
Time Frame: 16 weeks
by fecal sample
16 weeks
Proteomics
Time Frame: 16 weeks
by fasting blood sample
16 weeks
Proteomics
Time Frame: 16 weeks
by fecal sample
16 weeks
Genotypes
Time Frame: 16 weeks
by fasting blood sample
16 weeks
Adiponectin
Time Frame: 16 weeks
by fasting blood sample
16 weeks
Leptin
Time Frame: 16 weeks
by fasting blood sample
16 weeks
Appetite hormones
Time Frame: 16 weeks
by fasting blood sample
16 weeks
Testosterone
Time Frame: 16 weeks
by fasting blood sample
16 weeks
Estrogen
Time Frame: 16 weeks
by fasting blood sample
16 weeks
Gonadotropins
Time Frame: 16 weeks
by fasting blood sample
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Copenhagen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chalmers University of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 4, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 4, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D225

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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