Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
55 participants
INTERVENTIONAL
2020-09-03
2021-05-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Addition of Whole Grains to the Diets of Middle-school Children
NCT01094652
Effect of Armolipid on Lipid Profile in Children With Hypercholesterolemia
NCT06045377
Impact of Harvest Lentil Vegetable Blend and Nutrition Education on Turkana Children's Health Outcomes
NCT06866626
Effect of Iron Fortified Wheat Flour on Cognition and Iron Status in Indian School Children
NCT00741143
MA of Tryptophan in Cornmeal in Healthy Adults>60y
NCT07272668
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
High wholegrain then low wholegrain
Starting with high wholegrain intervention followed by low wholegrain intervention
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
Low wholegrain then high wholegrain
Starting with low wholegrain intervention followed by high wholegrain intervention
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
8 Years
13 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chalmers University of Technology
OTHER
University of Copenhagen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Camilla Trab Damsgaard
Associate Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Nutrition, Exercise and Sports, University of Copenhagen
Frederiksberg, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Madsen MTB, Landberg R, Nielsen DS, Zhang Y, Anneberg OMR, Lauritzen L, Damsgaard CT. Effects of Wholegrain Compared to Refined Grain Intake on Cardiometabolic Risk Markers, Gut Microbiota, and Gastrointestinal Symptoms in Children: A Randomized Crossover Trial. Am J Clin Nutr. 2024 Jan;119(1):18-28. doi: 10.1016/j.ajcnut.2023.10.025. Epub 2023 Oct 28.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D225
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.