Clinical trial NCT04430465: Effects of Wholegrains on Children's Health (KORN)
Official title: Effects of Wholegrains on Children's Health (KORN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiometabolic Health
Gastro-intestinal Wellbeing
Cognitive Function
Overweight
Keywords: Children
Wholegrain
Cardiovascular risk markers
Overweight
Adolescents
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Chalmers University of Technology
First posted: 2020-06-12
Enrollment: 55
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Low density lipoprotein cholesterol
timeFrame: 16 weeks
measure: Insulin
timeFrame: 16 weeks
Secondary outcomes:
measure: Height
timeFrame: 16 weeks
measure: Weight
timeFrame: 16 weeks
measure: Body Mass Index z-score
timeFrame: 16 weeks
measure: Waist circumference
timeFrame: 16 weeks
measure: Fat mass index
timeFrame: 16 weeks
measure: Fat free mass index
timeFrame: 16 weeks
measure: Systolic blood pressure
timeFrame: 16 weeks
measure: Diastolic blood pressure
timeFrame: 16 weeks
measure: Heart rate
timeFrame: 16 weeks
measure: Glucose
timeFrame: 16 weeks
measure: Glycosylated hemoglobin (HbA1c)
timeFrame: 16 weeks
measure: Triacylglycerol
timeFrame: 16 weeks
measure: High density lipoprotein cholesterol
timeFrame: 16 weeks
measure: Total cholesterol
timeFrame: 16 weeks
measure: High sensitivity C-reactive protein
timeFrame: 16 weeks
measure: Attention
timeFrame: 16 weeks
measure: Inhibition
timeFrame: 16 weeks
measure: Processing speed
timeFrame: 16 weeks
measure: Working memory
timeFrame: 16 weeks
measure: Socio-emotional skills
timeFrame: 16 weeks
measure: Stool consistency
timeFrame: 16 weeks
measure: Gastrointestinal wellbeing
timeFrame: 16 weeks
measure: Prevalence of overweight
timeFrame: 16 weeks
Other outcomes:
measure: Dietary intake
timeFrame: 16 weeks
measure: Physical activity
timeFrame: 16 weeks
measure: Sociodemographic characteristics
timeFrame: at baseline
measure: Pubertal development stage
timeFrame: at baseline
measure: General satisfaction
timeFrame: 16 weeks
measure: Liking of study products
timeFrame: 16 weeks
measure: Alkylresorcinols (compliance)
timeFrame: 16 weeks
measure: Android fat mass index
timeFrame: 16 weeks
measure: Gynoid fat mass index
timeFrame: 16 weeks
measure: Android:gynoid fat mass ratio
timeFrame: 16 weeks
measure: Immune cell count
timeFrame: 16 weeks
measure: Interleukin 6 (IL-6)
timeFrame: 16 weeks
measure: Interleukin 1β (IL-1β)
timeFrame: 16 weeks
measure: Tumor necrosis factor alpha (TNFα)
timeFrame: 16 weeks
measure: Bone Mineral Density
timeFrame: 16 weeks
measure: Bone Mineral Content
timeFrame: 16 weeks
measure: Bone area
timeFrame: 16 weeks
measure: Gut microbiome composition determined by high throughput sequencing and qPCR
timeFrame: 16 weeks
measure: Short chain fatty acids
timeFrame: 16 weeks
measure: Short chain fatty acids
timeFrame: 16 weeks
measure: Bile acids
timeFrame: 16 weeks
measure: Bile acids
timeFrame: 16 weeks
measure: Fatty acid composition
timeFrame: 16 weeks
measure: C-peptide
timeFrame: 16 weeks
measure: Epigenetics
timeFrame: 16 weeks
measure: Metabolomics
timeFrame: 16 weeks
measure: Metabolomics
timeFrame: 16 weeks
measure: Proteomics
timeFrame: 16 weeks
measure: Proteomics
timeFrame: 16 weeks
measure: Genotypes
timeFrame: 16 weeks
measure: Adiponectin
timeFrame: 16 weeks
measure: Leptin
timeFrame: 16 weeks
measure: Appetite hormones
timeFrame: 16 weeks
measure: Testosterone
timeFrame: 16 weeks
measure: Estrogen
timeFrame: 16 weeks
measure: Gonadotropins
timeFrame: 16 weeks
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Nutrition, Exercise and Sports, University of Copenhagen
Study officials:
References: