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OPUS School Meal Study

A

Arne Astrup

Status

Completed

Conditions

Metabolic Syndrome X

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01457794
H-1-2010-124 (Other Identifier)
D208

Details and patient eligibility

About

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.

Enrollment

834 patients

Sex

All

Ages

8 to 11 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

834 participants in 2 patient groups

NewNordicDiet first
Other group
Description:
Intervention with NND for 3 mo then no intervention for 3 mo
Treatment:
Other: School meals based on the principles of the New Nordic Diet
NewNordicDiet last
Other group
Description:
No intervention for 3 mo and then intervention with NND for 3 mo
Treatment:
Other: School meals based on the principles of the New Nordic Diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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