Cardiometabolic HealthNCT04430465
Effects of Wholegrains on Children's Health (KORN)
A study testing Grain products high in wholegrains from oat and rye and Grain products low in wholegrains in people with Cardiometabolic Health and Gastro-intestinal Wellbeing, run by University of Copenhagen at 1 site in Denmark.
Trial summary
KORN investigates the effects of wholegrain oat and rye intake on health and cognitive wellbeing in children with overweight. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Health, Gastro-intestinal Wellbeing, Cognitive Function
- What is being tested?
- Grain products high in wholegrains from oat and rye and Grain products low in wholegrains
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Sep 2020to 4 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nutrition, Exercise and Sports, University of Copenhagen
Frederiksberg
About this study
KORN investigates the effects of wholegrain oat and rye intake on health and cognitive wellbeing in children with overweight.
Read the 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.
- Being tested
- Grain products high in wholegrains from oat and rye, Grain products low in wholegrains
- Keywords
- Children, Wholegrain, Cardiovascular risk markers, Overweight, Adolescents
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grain products high in wholegrains from oat and ryeDietary supplement
Also called Wholegrain
A selection of grainproducts high in wholegrain from oat and rye, including cereals, bread, rolls, and pasta is replacing habitual grain products
Grain products low in wholegrainsDietary supplement
Also called Refined grain
A selection of grainproducts low in wholegrain, including cereals, bread, rolls, and pasta is replacing habitual grain products
| Study group | Role | What they receive |
|---|---|---|
| High wholegrain then low wholegrain | Experimental | Starting with high wholegrain intervention followed by low wholegrain intervention Receives: Dietary Supplement: Grain products high in wholegrains from oat and rye; Dietary Supplement: Grain products low in wholegrains |
| Low wholegrain then high wholegrain | Experimental | Starting with low wholegrain intervention followed by high wholegrain intervention Receives: Dietary Supplement: Grain products high in wholegrains from oat and rye; Dietary Supplement: Grain products low in wholegrains |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low density lipoprotein cholesterol
by fasting blood sample
Measured: 16 weeks
Insulin
by fasting blood sample
Measured: 16 weeks
Secondary outcomes (23)
Height
by stadiometer
Measured: 16 weeks
Weight
by digital scale
Measured: 16 weeks
Body Mass Index z-score
by height and weight measurements
Measured: 16 weeks
Waist circumference
by measuring tape
Measured: 16 weeks
Fat mass index
by Dual-energy X-ray Absorptiometry
Measured: 16 weeks
Fat free mass index
by Dual-energy X-ray Absorptiometry
Measured: 16 weeks
Systolic blood pressure
by digital device
Measured: 16 weeks
Diastolic blood pressure
by digital device
Measured: 16 weeks
Heart rate
by digital device
Measured: 16 weeks
Glucose
by fasting blood sample
Measured: 16 weeks
Glycosylated hemoglobin (HbA1c)
by fasting blood sample
Measured: 16 weeks
Triacylglycerol
by fasting blood sample
Measured: 16 weeks
High density lipoprotein cholesterol
by fasting blood sample
Measured: 16 weeks
Total cholesterol
by fasting blood sample
Measured: 16 weeks
High sensitivity C-reactive protein
by fasting blood sample
Measured: 16 weeks
Attention
assessed by d2 test of attention
Measured: 16 weeks
Inhibition
assessed by Stroop color and word test
Measured: 16 weeks
Processing speed
assessed by d2 test of attention and Stroop color and word test
Measured: 16 weeks
Working memory
assessed by Kim's game
Measured: 16 weeks
Socio-emotional skills
assessed by parent reported Strengths and Difficulties Questionnaire
Measured: 16 weeks
Stool consistency
assessed by the Bristol stool scale
Measured: 16 weeks
Gastrointestinal wellbeing
assessed by questionnaire
Measured: 16 weeks
Prevalence of overweight
By the International Obesity Task Force criteria
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start3 Sep 2020
- Primary completion4 May 2021
- Study completion4 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiometabolic HealthStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Chalmers University of Technology
- Responsible party
- Principal investigator, Camilla Trab Damsgaard, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430465
- Sponsor's protocol ID
- D225
- Status last verified
- Jan 2021
- First submitted
- 10 Jun 2020
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37898434
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Wholegrains on Children's Health (KORN)
- ClinicalTrials.gov ID
- NCT04430465
- Acronym / sponsor ID
- D225
- Keywords
- Children, Wholegrain, Cardiovascular risk markers, Overweight, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Chalmers University of Technology
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 4 May 2021 (actual)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High wholegrain then low wholegrain | Experimental | Dietary Supplement: Grain products high in wholegrains from oat and rye, Dietary Supplement: Grain products low in wholegrainsStarting with high wholegrain intervention followed by low wholegrain intervention |
| Low wholegrain then high wholegrain | Experimental | Dietary Supplement: Grain products high in wholegrains from oat and rye, Dietary Supplement: Grain products low in wholegrainsStarting with low wholegrain intervention followed by high wholegrain intervention |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grain products high in wholegrains from oat and ryeAlso: WholegrainA selection of grainproducts high in wholegrain from oat and rye, including cereals, bread, rolls, and pasta is replacing habitual grain products | Dietary supplement | High wholegrain then low wholegrain, Low wholegrain then high wholegrain |
| Grain products low in wholegrainsAlso: Refined grainA selection of grainproducts low in wholegrain, including cereals, bread, rolls, and pasta is replacing habitual grain products | Dietary supplement | High wholegrain then low wholegrain, Low wholegrain then high wholegrain |
Primary outcome
Low density lipoprotein cholesterol
Time frame: 16 weeks
by fasting blood sample
Insulin
Time frame: 16 weeks
by fasting blood sample
23 secondary outcomes
Height
Time frame: 16 weeks
Weight
Time frame: 16 weeks
Body Mass Index z-score
Time frame: 16 weeks
Waist circumference
Time frame: 16 weeks
Fat mass index
Time frame: 16 weeks
Fat free mass index
Time frame: 16 weeks
Systolic blood pressure
Time frame: 16 weeks
Diastolic blood pressure
Time frame: 16 weeks
Heart rate
Time frame: 16 weeks
Glucose
Time frame: 16 weeks
Glycosylated hemoglobin (HbA1c)
Time frame: 16 weeks
Triacylglycerol
Time frame: 16 weeks
High density lipoprotein cholesterol
Time frame: 16 weeks
Total cholesterol
Time frame: 16 weeks
High sensitivity C-reactive protein
Time frame: 16 weeks
Attention
Time frame: 16 weeks
Inhibition
Time frame: 16 weeks
Processing speed
Time frame: 16 weeks
Working memory
Time frame: 16 weeks
Socio-emotional skills
Time frame: 16 weeks
Stool consistency
Time frame: 16 weeks
Gastrointestinal wellbeing
Time frame: 16 weeks
Prevalence of overweight
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Derived from this study: PubMed 37898434Madsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grain products high in wholegrains from oat and rye and Grain products low in wholegrains in people with Cardiometabolic Health and Gastro-intestinal Wellbeing, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low density lipoprotein cholesterol (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04430465, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.