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Completed

NCT Number: NCT01457794

OPUS School Meal Study

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.

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Key information

Age range

8 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Copenhagen, 1958, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Metabolic syndrome score

    Time frame: Change during 3 month of intervention compared with change during 3 month control period

    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.

  2. Concentration Performance

    Time frame: Change during 3 month of intervention compared with change during 3 month control period

    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).

Secondary outcomes

  1. Early Cardiovascular Risk Markers

    Time frame: Change during 3 month of intervention compared with change during 3 month control period

    Systolic and diastolic blood pressure, serum blood cholesterol (total, Low Density Lipoprotein (LDL), Very Low Density Lipoprotein (VLDL) and HDL) and TG, plasma glucose, serum insulin and the HOMA index.

  2. Other metabolic syndrome scores

    Time frame: Change during 3 month of intervention compared with change during 3 month control period

    Other metabolic syndrome scores will be calculated as continuous z-scores based on each of the individual z-scores for Waist Circumference (WC), Mean Arterial Pressure (MAP), serum High Density Lipoprotein (HDL), serum Triglyceride (TG) and insulin, separately, and possibly with weighted contribution of each of the risk markers to the score.

  3. Inflammatory markers

    Time frame: Change during 3 month of intervention compared with change during 3 month control period

    Plasma concentrations of the cytokines Interleucin-6 (IL-6) and Tumor Necrosis Factor (TNF) alfa, the adipokine adiponectin and the acute-phase protein c-reactive protein (CRP) (measured as high-sensitive) in plasma will be used as markers of subclinical inflammation and related to the other early metabolic syndrome and cardiovascular risk markers.

  4. Illnesses and use of medicine

    Time frame: Change during 3 month of intervention compared with change during 3 month control period

    Self-reported data collected by computer-assisted questionnaire interview with the parents, either personal (month 0) or by telephone (month 3 and 6). Outcomes are the number of days, during the last two weeks, with: asthma symptoms, use of asthma-medicine, hay-fever symptoms, use of hay-fever-medicine, atopic eczema, symptoms such as sore throat or fever, and the use of pain killers or antibiotics. The number of days of absence from school due to illness, the number of days of illness during weekends and holidays, and number of visits to the doctor will also be evaluated.

  5. Use of ADHD medicine

    Time frame: Change during 3 month of intervention compared with change during 3 month control period

    Among those children with a diagnosis of Attention Deficit/Hyperactivity Disorder (ADHD) or Attention Deficit Disorder (ADD), the mean daily dose of methylphenidate (based on reported intake of drugs containing this substance) during the last two weeks will be evaluated.

  6. General fatty acid composition of whole-blood

    Time frame: Change during 3 month of intervention compared with change during 3 month control period

    Content of saturated fatty acids, monounsaturated fatty acids, polyunsaturated fatty acids, total n-3 and n-6 polyunsaturated fatty acids and the n-6:n-3 ratio in whole-blood measured as weight% relative to the weight of total fatty acids.

  7. Reading proficiency

    Time frame: Change during 3 month of intervention compared with change during 3 month control period

    Reading proficiency is assessed by means of the Danish Sentence Reading test 2 having two measures: Percentage of correct sentences read within eight minutes. Reading speed - number of sentences reached.

  8. Mathematics proficiency

    Time frame: Change during 3 month of intervention compared with change during 3 month control period

    Mathematics proficiency is assessed by means of the Danish MG test for 3rd and 4th grade. They each have one measure: Number of correct results within 45 minutes.

  9. Learning

    Time frame: Change during 3 month of intervention compared with change during 3 month control period

    Student learning is assessed by means of the Danish LRS Learning Rating Scale filled out by students. The scale contains four subscales and one combined scale (sum score) adding the four subscales. The subscales cover: academic learning, social situation in school, teaching style appropriateness, and school expectations.

  10. Wellness

    Time frame: Change during 3 month of intervention compared with change during 3 month control period

    Student wellness is assessed by means of the Danish WRS Wellness Rating Scale filled out by students. The scale contains five subscales and one combined scale (sum score) adding the five subscales. The subscales cover: Living environment, school, school mates, family, and self concept.

  11. Physical activity

    Time frame: Change during 3 month of intervention compared with change during 3 month control period

    Physical activity is measured using actigraphy. Outcome measures will be counts/min, time spent in sedentary, light, moderate and vigorous activities.

    Questions regarding TV-watching, playing with videogames and physical activity, will help identify activity-pattern.

  12. Sleep

    Time frame: Change during 3 month of intervention compared with change during 3 month control period

    Sleep is measured using actigraphy with the monitor placed on the right hip for all students and on the non-dominant wrist for a sub-sample. Using a sleep diary, total sleep time and sleep efficiency will be derived from these actigraphy measurements.

    In addition, at month 0, the abbreviated version of the Children's Sleep Habits Questionnaire (CSHQ) is used to identify sleep problems.

  13. Fitness

    Time frame: Change during 3 month of intervention compared with change during 3 month control period

    Fitness is measured using the Andersen test, which is an intermittent running test to estimate maximal oxygen uptake (mL*min-1*kg-1).

  14. Dietary intake

    Time frame: Change during 3 month of intervention compared with change during 3 month control period

    Dietary intake is measured as micro-and macronutrients as well as food groups (e.g. fish and fruit/vegetables) by means of a 7-day dietary survey, which is a web based recall record method developed especially for children. Families without internet access can use a paper version of a 7-day dietary survey. The meal time perception is measured as well.

  15. Body weight and body mass index (BMI)

    Time frame: Change during 3 month of intervention compared with change during 3 month control period

    Body weight (in kg, BMI and BMI z-score calculated on the basis of the current references from the World Health Organization (WHO)

  16. Body composition

    Time frame: Change during 3 month of intervention compared with change during 3 month control period

    Body composition will be determined by Dual energy X-ray Absorptiometry (DXA) scanning. The parameters included are total body Fat Free Mass Index (FFMI in kg/m2), total body Fat Mass Index (FMI in kg/m2), total body fat percentage and the ratio between android and gynoid fat mass in kg.

  17. Appetite-regulating hormones

    Time frame: Change during 3 month of intervention compared with change during 3 month control period

    Leptin and ghrelin. If resources are available at the end of the study period, ghrelin will be separated in acylated and deacylated ghrelin, and both the effect of the intervention on total, acylated, deacylated and the ratio between acylated:deacylated ghrelin will be assessed. If the resources are too tight at the end of the study, only total ghrelin will be used.

  18. Vitamin D status

    Time frame: Baseline and change during 3 month of intervention compared with change during 3 month control period

    Serum concentrations of 25-hydroxyvitamin D [25(OH)D] will be used as marker of vitamin D status, related to food intake and time of season.

  19. Bone Health

    Time frame: Change during 3 month of intervention compared with change during 3 month control period

    Bone Health will be evaluated by DXA scanning (total body and spine Bone Mineral Content (BMC), Bone Mineral Density (BMD), and Bone Area (BA). Osteocalcin and serum Parathyreoideahormon (PTH) are also included as markers of bone health.

  20. General fatty acid composition in whole-blood

    Time frame: Change during 3 month intervnetion compared with change during 3 month control period

  21. Iron status

    Time frame: Change during 3 month intervention compared with 3 month control period

    Whole-blood hemoglobin and serum ferritin will be used as measures of iron status

  22. Attention - other measures

    Time frame: Change during 3 month of intervention compared with change during 3 month control period

    The following five measures from the attention test D2 will be used:

    TN=Total Number of items processed E%=Percentage of errors

  23. Omega-3 index in whole-blood

    Time frame: Change during 3 month of intervention compared with change during 3 month control period

    The Omega-3 index in whole-blood is defined as the weight percentage of eicosapentaenoicacid + the weight percentage of docosahexaenoic acid in whole-blood

Other outcomes

  1. Genotyping

    Time frame: Baseline

    SNPs in genes related to metabolic pathways, messenger molecules, receptors or other genes that may affect efficacy measures in OPUS School Food Project

Sponsors and collaborators

Lead sponsor

Arne Astrup

Other

Collaborators

  • Technical University of Denmark
  • University Hospital, Gentofte, Copenhagen
  • University of Aarhus

Registry information

Official study title

OPUS(Optimal Well-being, Development and Health for Danish Children Through a Healthy New Nordic Diet) School Meal Study

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 24, 2011
Registry last updated
Mar 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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