Effects of Wholegrains on Children's Health (KORN)
Sleutelwoorden
Abstract
Omschrijving
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.
Datums
| Laatst geverifieerd: | 05/31/2020 |
| Eerste ingediend: | 06/09/2020 |
| Geschatte inschrijving ingediend: | 06/09/2020 |
| Eerst geplaatst: | 06/11/2020 |
| Laatste update ingediend: | 06/15/2020 |
| Laatste update geplaatst: | 06/17/2020 |
| Werkelijke startdatum van het onderzoek: | 07/31/2020 |
| Geschatte primaire voltooiingsdatum: | 05/31/2021 |
| Geschatte voltooiingsdatum van het onderzoek: | 05/31/2021 |
Conditie of ziekte
Interventie / behandeling
Dietary Supplement: Grain products high in wholegrains from oat and rye
Dietary Supplement: Grain products low in wholegrains
Fase
Armgroepen
| Arm | Interventie / behandeling |
|---|---|
| Experimental: High wholegrain then low wholegrain Starting with high wholegrain intervention followed by low wholegrain intervention | |
| Experimental: Low wholegrain then high wholegrain Starting with low wholegrain intervention followed by high wholegrain intervention |
Geschiktheidscriteria
| Leeftijden die in aanmerking komen voor studie | 8 Years Naar 8 Years |
| Geslachten die in aanmerking komen voor studie | All |
| Accepteert gezonde vrijwilligers | Ja |
| 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 |
Resultaat
Primaire uitkomstmaten
1. Low density lipoprotein cholesterol [16 weeks]
2. Insulin [16 weeks]
Secundaire uitkomstmaten
1. Height [16 weeks]
2. Weight [16 weeks]
3. Body Mass Index z-score [16 weeks]
4. Waist circumference [16 weeks]
5. Fat mass index [16 weeks]
6. Fat free mass index [16 weeks]
7. Systolic blood pressure [16 weeks]
8. Diastolic blood pressure [16 weeks]
9. Heart rate [16 weeks]
10. Glucose [16 weeks]
11. Glycosylated hemoglobin (HbA1c) [16 weeks]
12. Triacylglycerol [16 weeks]
13. High density lipoprotein cholesterol [16 weeks]
14. Total cholesterol [16 weeks]
15. High sensitivity C-reactive protein [16 weeks]
16. Attention [16 weeks]
17. Inhibition [16 weeks]
18. Processing speed [16 weeks]
19. Working memory [16 weeks]
20. Socio-emotional skills [16 weeks]
21. Stool consistency [16 weeks]
22. Gastrointestinal wellbeing [16 weeks]
23. Prevalence of overweight [16 weeks]
Andere uitkomstmaten
1. Dietary intake [16 weeks]
2. Physical activity [16 weeks]
3. Sociodemographic characteristics [at baseline]
4. Pubertal development stage [at baseline]
5. General satisfaction [16 weeks]
6. Liking of study products [16 weeks]
7. Alkylresorcinols (compliance) [16 weeks]
8. Android fat mass index [16 weeks]
9. Gynoid fat mass index [16 weeks]
10. Android:gynoid fat mass ratio [16 weeks]
11. Immune cell count [16 weeks]
12. Interleukin 6 (IL-6) [16 weeks]
13. Interleukin 1β (IL-1β) [16 weeks]
14. Tumor necrosis factor alpha (TNFα) [16 weeks]
15. Bone Mineral Density [16 weeks]
16. Bone Mineral Content [16 weeks]
17. Bone area [16 weeks]
18. Gut microbiome composition determined by high throughput sequencing and qPCR [16 weeks]
19. Short chain fatty acids [16 weeks]
20. Short chain fatty acids [16 weeks]
21. Bile acids [16 weeks]
22. Bile acids [16 weeks]
23. Fatty acid composition [16 weeks]
24. C-peptide [16 weeks]
25. Epigenetics [16 weeks]
26. Metabolomics [16 weeks]
27. Metabolomics [16 weeks]
28. Proteomics [16 weeks]
29. Proteomics [16 weeks]
30. Genotypes [16 weeks]
31. Adiponectin [16 weeks]
32. Leptin [16 weeks]
33. Appetite hormones [16 weeks]
34. Testosterone [16 weeks]
35. Estrogen [16 weeks]
36. Gonadotropins [16 weeks]
