Effects of Wholegrains on Children's Health (KORN)

Overweight Clinical Trial

Official title:

Effects of Wholegrains on Children's Health (KORN)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04430465
• Other study ID #: D225
• Status: Completed
• Phase: N/A
• Start date: September 3, 2020
• Est. completion date: May 4, 2021

Study information

• Verified date: January 2021
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: May 4, 2021
• Est. primary completion date: May 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiometabolic Health
• Cognitive Function
• Gastro-intestinal Wellbeing
• Overweight

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

Locations

Country	Name	City	State
Denmark	Department of Nutrition, Exercise and Sports, University of Copenhagen	Frederiksberg

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Chalmers University of Technology

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dietary intake	assessed by 4-day dietary record	16 weeks
Other	Physical activity	assessed by questionnaire	16 weeks
Other	Sociodemographic characteristics	assessed by questionnaire	at baseline
Other	Pubertal development stage	assessed by the Tanner scales	at baseline
Other	General satisfaction	assessed by questionnaire	16 weeks
Other	Liking of study products	assessed by questionnaire	16 weeks
Other	Alkylresorcinols (compliance)	by fasting blood sample	16 weeks
Other	Android fat mass index	by Dual-energy X-ray Absorptiometry	16 weeks
Other	Gynoid fat mass index	by Dual-energy X-ray Absorptiometry	16 weeks
Other	Android:gynoid fat mass ratio	by Dual-energy X-ray Absorptiometry	16 weeks
Other	Immune cell count	by fasting blood sample	16 weeks
Other	Interleukin 6 (IL-6)	by fasting blood sample	16 weeks
Other	Interleukin 1ß (IL-1ß)	by fasting blood sample	16 weeks
Other	Tumor necrosis factor alpha (TNFa)	by fasting blood sample	16 weeks
Other	Bone Mineral Density	by Dual-energy X-ray Absorptiometry	16 weeks
Other	Bone Mineral Content	by Dual-energy X-ray Absorptiometry	16 weeks
Other	Bone area	by Dual-energy X-ray Absorptiometry	16 weeks
Other	Gut microbiome composition determined by high throughput sequencing and qPCR	by fecal sample	16 weeks
Other	Short chain fatty acids	by fasting blood sample	16 weeks
Other	Short chain fatty acids	by fecal sample	16 weeks
Other	Bile acids	by fasting blood sample	16 weeks
Other	Bile acids	by fecal sample	16 weeks
Other	Fatty acid composition	by fasting blood sample	16 weeks
Other	C-peptide	by fasting blood sample	16 weeks
Other	Epigenetics	by fasting blood sample	16 weeks
Other	Metabolomics	by fasting blood sample	16 weeks
Other	Metabolomics	by fecal sample	16 weeks
Other	Proteomics	by fasting blood sample	16 weeks
Other	Proteomics	by fecal sample	16 weeks
Other	Genotypes	by fasting blood sample	16 weeks
Other	Adiponectin	by fasting blood sample	16 weeks
Other	Leptin	by fasting blood sample	16 weeks
Other	Appetite hormones	by fasting blood sample	16 weeks
Other	Testosterone	by fasting blood sample	16 weeks
Other	Estrogen	by fasting blood sample	16 weeks
Other	Gonadotropins	by fasting blood sample	16 weeks
Primary	Low density lipoprotein cholesterol	by fasting blood sample	16 weeks
Primary	Insulin	by fasting blood sample	16 weeks
Secondary	Height	by stadiometer	16 weeks
Secondary	Weight	by digital scale	16 weeks
Secondary	Body Mass Index z-score	by height and weight measurements	16 weeks
Secondary	Waist circumference	by measuring tape	16 weeks
Secondary	Fat mass index	by Dual-energy X-ray Absorptiometry	16 weeks
Secondary	Fat free mass index	by Dual-energy X-ray Absorptiometry	16 weeks
Secondary	Systolic blood pressure	by digital device	16 weeks
Secondary	Diastolic blood pressure	by digital device	16 weeks
Secondary	Heart rate	by digital device	16 weeks
Secondary	Glucose	by fasting blood sample	16 weeks
Secondary	Glycosylated hemoglobin (HbA1c)	by fasting blood sample	16 weeks
Secondary	Triacylglycerol	by fasting blood sample	16 weeks
Secondary	High density lipoprotein cholesterol	by fasting blood sample	16 weeks
Secondary	Total cholesterol	by fasting blood sample	16 weeks
Secondary	High sensitivity C-reactive protein	by fasting blood sample	16 weeks
Secondary	Attention	assessed by d2 test of attention	16 weeks
Secondary	Inhibition	assessed by Stroop color and word test	16 weeks
Secondary	Processing speed	assessed by d2 test of attention and Stroop color and word test	16 weeks
Secondary	Working memory	assessed by Kim's game	16 weeks
Secondary	Socio-emotional skills	assessed by parent reported Strengths and Difficulties Questionnaire	16 weeks
Secondary	Stool consistency	assessed by the Bristol stool scale	16 weeks
Secondary	Gastrointestinal wellbeing	assessed by questionnaire	16 weeks
Secondary	Prevalence of overweight	By the International Obesity Task Force criteria	16 weeks