Effects of Wholegrains on Children's Health (KORN)

Not Applicable

Completed

• Conditions: Cardiometabolic Health; Gastro-intestinal Wellbeing; Overweight; Cognitive Function
• Interventions: Dietary Supplement: Grain products high in wholegrains from oat and rye; Dietary Supplement: Grain products low in wholegrains

• Registration Number: NCT04430465
• Lead Sponsor: University of Copenhagen

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.

Study Timeline

• Study First Submitted: 2020-06-10
• Study First Submitted QC: 2020-06-10
• Study First Posted: 2020-06-12
• Study Start: 2020-09-03
• Status Verified: 2021-01
• Primary Completion: 2021-05-04
• Study Completion: 2021-05-04
• Last Update Submitted: 2021-05-06
• Last Update Posted: 2021-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low wholegrain then high wholegrain	Grain products low in wholegrains	Starting with low wholegrain intervention followed by high wholegrain intervention
High wholegrain then low wholegrain	Grain products high in wholegrains from oat and rye	Starting with high wholegrain intervention followed by low wholegrain intervention
High wholegrain then low wholegrain	Grain products low in wholegrains	Starting with high wholegrain intervention followed by low wholegrain intervention
Low wholegrain then high wholegrain	Grain products high in wholegrains from oat and rye	Starting with low wholegrain intervention followed by high wholegrain intervention

Primary Outcome Measures

Name	Time	Method
Low density lipoprotein cholesterol	16 weeks	by fasting blood sample
Insulin	16 weeks	by fasting blood sample

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Nutrition, Exercise and Sports, University of Copenhagen; 🇩🇰 Frederiksberg, Denmark