Effects of Wholegrains on Children's Health (KORN)
מילות מפתח
תַקצִיר
תיאור
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.
תאריכים
| אומת לאחרונה: | 05/31/2020 |
| הוגש לראשונה: | 06/09/2020 |
| ההרשמה המשוערת הוגשה: | 06/09/2020 |
| פורסם לראשונה: | 06/11/2020 |
| העדכון האחרון הוגש: | 06/15/2020 |
| עדכון אחרון פורסם: | 06/17/2020 |
| תאריך תחילת לימוד בפועל: | 07/31/2020 |
| תאריך סיום משוער משוער: | 05/31/2021 |
| תאריך סיום משוער ללימודים: | 05/31/2021 |
מצב או מחלה
התערבות / טיפול
Dietary Supplement: Grain products high in wholegrains from oat and rye
Dietary Supplement: Grain products low in wholegrains
שלב
קבוצות זרועות
| זְרוֹעַ | התערבות / טיפול |
|---|---|
| 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 |
קריטריונים לזכאות
| גילאים הזכאים ללימודים | 8 Years ל 8 Years |
| מינים הזכאים ללימודים | All |
| מקבל מתנדבים בריאים | כן |
| קריטריונים | 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 |
תוֹצָאָה
מדדי תוצאות ראשוניים
1. Low density lipoprotein cholesterol [16 weeks]
2. Insulin [16 weeks]
אמצעי תוצאה משניים
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]
אמצעי תוצאה אחרים
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]
