Clinical trial NCT01457794: OPUS School Meal Study
Official title: OPUS(Optimal Well-being, Development and Health for Danish Children Through a Healthy New Nordic Diet) School Meal Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome X
Keywords: Metabolic Syndrome X
Fatty Acids, Omega-3
Learning
Attention
Nutritional Status
Nutrition Assessments
Body Weight
Physical Activity
Sleep
Child Nutrition Sciences
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Technical University of Denmark
name: University of Aarhus
name: University Hospital, Gentofte, Copenhagen
First posted: 2011-10-24
Enrollment: 834
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this randomized crossover study, is to investigate the effect of school meals based on a sustainable New Nordic Diet on growth, learning abilities, well-being, sleep quality, physical activity and risk markers of cardiovascular disease (CVD), type II diabetes and osteoporosis in 8-11 year old Danish school children.

The participating 3rd and 4th grades on 9 selected primary schools will be randomized to either start receiving New Nordic Diet school meals for 3 month(mo) or to eat their habitual school lunch for 3 mo and then crossover for additional 3 mo. All participants will be examined three times; at baseline, after 3 mo and after 6 mo.


Eligibility criteria: Inclusion Criteria:

* Pupils in 3rd and 4th grades
* Primary Schools in the Zealand Region and Capital Region of Denmark
* Schools with an available school kitchen, that can be approved by the food authorities
* Schools where at least 60 % of the pupils in three or more classes signs up to participate in the Study

Exclusion Criteria:

* The children should not participate in a scientific study or have participated in a scientific study within the last 4 weeks. This, however depends on the character of the other study.
* The children must not suffer from serious food allergies or food intolerance.
* The children must not suffer from diseases or conditions that makes them ill-suited for participation in the study, eg. malabsorptive conditions or serious mental disorders
* The Schools must not offer an well-established common meal plan, that provides most of the pupils with healthy food on a daily basis

Primary outcomes:
measure: Metabolic syndrome score
timeFrame: Change during 3 month of intervention compared with change during 3 month control period
measure: Concentration Performance
timeFrame: Change during 3 month of intervention compared with change during 3 month control period
Secondary outcomes:
measure: Early Cardiovascular Risk Markers
timeFrame: Change during 3 month of intervention compared with change during 3 month control period
measure: Other metabolic syndrome scores
timeFrame: Change during 3 month of intervention compared with change during 3 month control period
measure: Inflammatory markers
timeFrame: Change during 3 month of intervention compared with change during 3 month control period
measure: Illnesses and use of medicine
timeFrame: Change during 3 month of intervention compared with change during 3 month control period
measure: Use of ADHD medicine
timeFrame: Change during 3 month of intervention compared with change during 3 month control period
measure: General fatty acid composition of whole-blood
timeFrame: Change during 3 month of intervention compared with change during 3 month control period
measure: Reading proficiency
timeFrame: Change during 3 month of intervention compared with change during 3 month control period
measure: Mathematics proficiency
timeFrame: Change during 3 month of intervention compared with change during 3 month control period
measure: Learning
timeFrame: Change during 3 month of intervention compared with change during 3 month control period
measure: Wellness
timeFrame: Change during 3 month of intervention compared with change during 3 month control period
measure: Physical activity
timeFrame: Change during 3 month of intervention compared with change during 3 month control period
measure: Sleep
timeFrame: Change during 3 month of intervention compared with change during 3 month control period
measure: Fitness
timeFrame: Change during 3 month of intervention compared with change during 3 month control period
measure: Dietary intake
timeFrame: Change during 3 month of intervention compared with change during 3 month control period
measure: Body weight and body mass index (BMI)
timeFrame: Change during 3 month of intervention compared with change during 3 month control period
measure: Body composition
timeFrame: Change during 3 month of intervention compared with change during 3 month control period
measure: Appetite-regulating hormones
timeFrame: Change during 3 month of intervention compared with change during 3 month control period
measure: Vitamin D status
timeFrame: Baseline and change during 3 month of intervention compared with change during 3 month control period
measure: Bone Health
timeFrame: Change during 3 month of intervention compared with change during 3 month control period
measure: General fatty acid composition in whole-blood
timeFrame: Change during 3 month intervnetion compared with change during 3 month control period
measure: Iron status
timeFrame: Change during 3 month intervention compared with 3 month control period
measure: Attention - other measures
timeFrame: Change during 3 month of intervention compared with change during 3 month control period
measure: Omega-3 index in whole-blood
timeFrame: Change during 3 month of intervention compared with change during 3 month control period
Other outcomes:
measure: Genotyping
timeFrame: Baseline
Locations:
city: Copenhagen
country: Denmark
facility: Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
Study officials:
References:
citation: Lauritzen L, Sorensen LB, Harslof LB, Ritz C, Stark KD, Astrup A, Dyssegaard CB, Egelund N, Michaelsen KF, Damsgaard CT. Mendelian randomization shows sex-specific associations between long-chain PUFA-related genotypes and cognitive performance in Danish schoolchildren. Am J Clin Nutr. 2017 Jul;106(1):88-95. doi: 10.3945/ajcn.117.152595. Epub 2017 May 17.
citation: Biltoft-Jensen A, Damsgaard CT, Andersen EW, Ygil KH, Andersen R, Ege M, Christensen T, Thorsen AV, Tetens I, Wu H, Landberg R. Validation of Reported Whole-Grain Intake from a Web-Based Dietary Record against Plasma Alkylresorcinol Concentrations in 8- to 11-Year-Olds Participating in a Randomized Controlled Trial. J Nutr. 2016 Feb;146(2):377-83. doi: 10.3945/jn.115.222620. Epub 2016 Jan 13.
citation: Sorensen LB, Dyssegaard CB, Damsgaard CT, Petersen RA, Dalskov SM, Hjorth MF, Andersen R, Tetens I, Ritz C, Astrup A, Lauritzen L, Michaelsen KF, Egelund N. The effects of Nordic school meals on concentration and school performance in 8- to 11-year-old children in the OPUS School Meal Study: a cluster-randomised, controlled, cross-over trial. Br J Nutr. 2015 Apr 28;113(8):1280-91. doi: 10.1017/S0007114515000033. Epub 2015 Mar 20.
citation: Dalskov SM, Ritz C, Larnkjaer A, Damsgaard CT, Petersen RA, Sorensen LB, Ong KK, Astrup A, Molgaard C, Michaelsen KF. The role of leptin and other hormones related to bone metabolism and appetite regulation as determinants of gain in body fat and fat-free mass in 8-11-year-old children. J Clin Endocrinol Metab. 2015 Mar;100(3):1196-205. doi: 10.1210/jc.2014-3706. Epub 2014 Dec 22.
citation: Hjorth MF, Quist JS, Andersen R, Michaelsen KF, Tetens I, Astrup A, Chaput JP, Sjodin A. Change in sleep duration and proposed dietary risk factors for obesity in Danish school children. Pediatr Obes. 2014 Dec;9(6):e156-9. doi: 10.1111/ijpo.264. Epub 2014 Sep 24.