Effects of Wholegrains on Children's Health (KORN)

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

Study Overview

• Status: Completed
• Conditions: Overweight; Cognitive Function; Cardiometabolic Health; Gastro-intestinal Wellbeing
• Intervention / Treatment: Dietary supplement: Grain products high in wholegrains from oat and rye; Dietary supplement: Grain products low in wholegrains

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: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Low density lipoprotein cholesterol	by fasting blood sample	16 weeks
Insulin	by fasting blood sample	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height	by stadiometer	16 weeks
Weight	by digital scale	16 weeks
Body Mass Index z-score	by height and weight measurements	16 weeks
Waist circumference	by measuring tape	16 weeks
Fat mass index	by Dual-energy X-ray Absorptiometry	16 weeks
Fat free mass index	by Dual-energy X-ray Absorptiometry	16 weeks
Systolic blood pressure	by digital device	16 weeks
Diastolic blood pressure	by digital device	16 weeks
Heart rate	by digital device	16 weeks
Glucose	by fasting blood sample	16 weeks
Glycosylated hemoglobin (HbA1c)	by fasting blood sample	16 weeks
Triacylglycerol	by fasting blood sample	16 weeks
High density lipoprotein cholesterol	by fasting blood sample	16 weeks
Total cholesterol	by fasting blood sample	16 weeks
High sensitivity C-reactive protein	by fasting blood sample	16 weeks
Attention	assessed by d2 test of attention	16 weeks
Inhibition	assessed by Stroop color and word test	16 weeks
Processing speed	assessed by d2 test of attention and Stroop color and word test	16 weeks
Working memory	assessed by Kim's game	16 weeks
Socio-emotional skills	assessed by parent reported Strengths and Difficulties Questionnaire	16 weeks
Stool consistency	assessed by the Bristol stool scale	16 weeks
Gastrointestinal wellbeing	assessed by questionnaire	16 weeks
Prevalence of overweight	By the International Obesity Task Force criteria	16 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary intake	assessed by 4-day dietary record	16 weeks
Physical activity	assessed by questionnaire	16 weeks
Sociodemographic characteristics	assessed by questionnaire	at baseline
Pubertal development stage	assessed by the Tanner scales	at baseline
General satisfaction	assessed by questionnaire	16 weeks
Liking of study products	assessed by questionnaire	16 weeks
Alkylresorcinols (compliance)	by fasting blood sample	16 weeks
Android fat mass index	by Dual-energy X-ray Absorptiometry	16 weeks
Gynoid fat mass index	by Dual-energy X-ray Absorptiometry	16 weeks
Android:gynoid fat mass ratio	by Dual-energy X-ray Absorptiometry	16 weeks
Immune cell count	by fasting blood sample	16 weeks
Interleukin 6 (IL-6)	by fasting blood sample	16 weeks
Interleukin 1β (IL-1β)	by fasting blood sample	16 weeks
Tumor necrosis factor alpha (TNFα)	by fasting blood sample	16 weeks
Bone Mineral Density	by Dual-energy X-ray Absorptiometry	16 weeks
Bone Mineral Content	by Dual-energy X-ray Absorptiometry	16 weeks
Bone area	by Dual-energy X-ray Absorptiometry	16 weeks
Gut microbiome composition determined by high throughput sequencing and qPCR	by fecal sample	16 weeks
Short chain fatty acids	by fasting blood sample	16 weeks
Short chain fatty acids	by fecal sample	16 weeks
Bile acids	by fasting blood sample	16 weeks
Bile acids	by fecal sample	16 weeks
Fatty acid composition	by fasting blood sample	16 weeks
C-peptide	by fasting blood sample	16 weeks
Epigenetics	by fasting blood sample	16 weeks
Metabolomics	by fasting blood sample	16 weeks
Metabolomics	by fecal sample	16 weeks
Proteomics	by fasting blood sample	16 weeks
Proteomics	by fecal sample	16 weeks
Genotypes	by fasting blood sample	16 weeks
Adiponectin	by fasting blood sample	16 weeks
Leptin	by fasting blood sample	16 weeks
Appetite hormones	by fasting blood sample	16 weeks
Testosterone	by fasting blood sample	16 weeks
Estrogen	by fasting blood sample	16 weeks
Gonadotropins	by fasting blood sample	16 weeks

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Chalmers University of Technology

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2020
• Primary Completion (Actual): May 4, 2021
• Study Completion (Actual): May 4, 2021

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 10, 2020
• First Posted (Actual): June 12, 2020

Study Record Updates

• Last Update Posted (Actual): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 6, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Adolescents; Children; Overweight; Cardiovascular risk markers; Wholegrain
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID 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