OPUS School Meal Study

NCT01457794 | Completed

• 2 other identifiers: D208H-1-2010-124
• Study Type: interventional
• Target: 834
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Metabolic syndrome score

  The metabolic syndrome score is a continuous z-score based on individual z-scores for waist circumference (WC), mean arterial pressure (MAP), serum high density lipoprotein (HDL), Serum triglyceride (TG) and Homeostasis Model Assessment (HOMA) index. It´s an internal score meaning that the basis for the score is the distribution of values in this study population at baseline.

  Change during 3 month of intervention compared with change during 3 month control period

• Concentration Performance

  Concentration Performance is assessed by means of a concentration test called the D2-test of Attention. Concentration Performance is derived from the number of correctly crossed out relevant items minus the errors of commission (confused).

  Change during 3 month of intervention compared with change during 3 month control period

Secondary Outcomes (23)

• Early Cardiovascular Risk Markers

  Change during 3 month of intervention compared with change during 3 month control period

• Other metabolic syndrome scores

  Change during 3 month of intervention compared with change during 3 month control period

• Inflammatory markers

  Change during 3 month of intervention compared with change during 3 month control period

• Illnesses and use of medicine

  Change during 3 month of intervention compared with change during 3 month control period

• Use of ADHD medicine

  Change during 3 month of intervention compared with change during 3 month control period

Other Outcomes (1)

• Genotyping

  Baseline

Study Arms (2)

NewNordicDiet first

OTHER

Intervention with NND for 3 mo then no intervention for 3 mo

Other: School meals based on the principles of the New Nordic Diet

NewNordicDiet last

OTHER

No intervention for 3 mo and then intervention with NND for 3 mo

Other: School meals based on the principles of the New Nordic Diet

Interventions

School meals based on the principles of the New Nordic Diet OTHER

The study participants are provided with three daily school meals for 3 month

NewNordicDiet first; NewNordicDiet last

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arne Astrup: lead
• Technical University of Denmark: collaborator
• University of Aarhus: collaborator
• University Hospital, Gentofte, Copenhagen: collaborator

Study Sites (1)

Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen

Copenhagen, 1958, Denmark

Location

Related Publications (5)

• 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.

  PMID: 28515069 DERIVED

• 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.

  PMID: 26764319 DERIVED

• 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.

  PMID: 25791747 DERIVED

• 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.

  PMID: 25532044 DERIVED

• 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.

  PMID: 25251317 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Body Weight; Motor Activity

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: October 20, 2011
• First Posted: October 24, 2011
• Study Start: May 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: March 6, 2017

Record last verified: 2017-03

Locations

DK (1)