Effects of Wholegrains on Children's Health (KORN)

University of Copenhagen55 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Cardiometabolic Health Gastro-intestinal Wellbeing Cognitive Function Overweight

Interventions

Grain products high in wholegrains from oat and ryeDIETARY_SUPPLEMENT

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

A selection of grainproducts low in wholegrain, including cereals, bread, rolls, and pasta is replacing habitual grain products

Eligibility

Sex: ALLMin age: 8 YearsMax age: 13 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg, Denmark

Outcomes

Primary Outcomes

Low density lipoprotein cholesterol

by fasting blood sample

Time frame: 16 weeks

Insulin

by fasting blood sample

Time frame: 16 weeks

Secondary Outcomes

Height

by stadiometer

Time frame: 16 weeks

Weight

by digital scale

Time frame: 16 weeks

Body Mass Index z-score

by height and weight measurements

Time frame: 16 weeks

Waist circumference

by measuring tape

Time frame: 16 weeks

Fat mass index

by Dual-energy X-ray Absorptiometry

Time frame: 16 weeks

Fat free mass index

by Dual-energy X-ray Absorptiometry

Time frame: 16 weeks

Systolic blood pressure

by digital device

Time frame: 16 weeks

Diastolic blood pressure

by digital device

Time frame: 16 weeks

Data from ClinicalTrials.gov

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