Back to resultsOPUS School Meal Study
Primary Purpose
Metabolic Syndrome X
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
School meals based on the principles of the New Nordic Diet
Sponsored by
About this trial
This is an interventional basic science trial for Metabolic Syndrome X focused on measuring Metabolic Syndrome X, Fatty Acids, Omega-3, Learning, Attention, Nutritional Status, Nutrition Assessments, Body Weight, Physical Activity, Sleep, Child Nutrition Sciences
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
Sites / Locations
- Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
NewNordicDiet first
NewNordicDiet last
Arm Description
Intervention with NND for 3 mo then no intervention for 3 mo
No intervention for 3 mo and then intervention with NND for 3 mo
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
Early Cardiovascular Risk Markers
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.
Other metabolic syndrome scores
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.
Inflammatory markers
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.
Illnesses and use of medicine
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.
Use of ADHD medicine
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.
General fatty acid composition of whole-blood
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.
Reading proficiency
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.
Mathematics proficiency
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.
Learning
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.
Wellness
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.
Physical activity
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.
Sleep
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.
Fitness
Fitness is measured using the Andersen test, which is an intermittent running test to estimate maximal oxygen uptake (mL*min-1*kg-1).
Dietary intake
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.
Body weight and body mass index (BMI)
Body weight (in kg, BMI and BMI z-score calculated on the basis of the current references from the World Health Organization (WHO)
Body composition
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.
Appetite-regulating hormones
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.
Vitamin D status
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.
Bone Health
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.
General fatty acid composition in whole-blood
Iron status
Whole-blood hemoglobin and serum ferritin will be used as measures of iron status
Attention - other measures
The following five measures from the attention test D2 will be used:
TN=Total Number of items processed E%=Percentage of errors
Omega-3 index in whole-blood
The Omega-3 index in whole-blood is defined as the weight percentage of eicosapentaenoicacid + the weight percentage of docosahexaenoic acid in whole-blood
Full Information
NCT ID
NCT01457794
First Posted
October 20, 2011
Last Updated
March 3, 2017
Sponsor
Arne Astrup
Collaborators
Technical University of Denmark, University of Aarhus, University Hospital, Gentofte, Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT01457794
Brief Title
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
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Arne Astrup
Collaborators
Technical University of Denmark, University of Aarhus, University Hospital, Gentofte, Copenhagen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
834 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NewNordicDiet first
Arm Type
Other
Arm Description
Intervention with NND for 3 mo then no intervention for 3 mo
Arm Title
NewNordicDiet last
Arm Type
Other
Arm Description
No intervention for 3 mo and then intervention with NND for 3 mo
Intervention Type
Other
Intervention Name(s)
School meals based on the principles of the New Nordic Diet
Intervention Description
The study participants are provided with three daily school meals for 3 month
Primary Outcome Measure Information:
Title
Metabolic syndrome score
Description
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.
Time Frame
Change during 3 month of intervention compared with change during 3 month control period
Title
Concentration Performance
Description
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).
Time Frame
Change during 3 month of intervention compared with change during 3 month control period
Secondary Outcome Measure Information:
Title
Early Cardiovascular Risk Markers
Description
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.
Time Frame
Change during 3 month of intervention compared with change during 3 month control period
Title
Other metabolic syndrome scores
Description
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.
Time Frame
Change during 3 month of intervention compared with change during 3 month control period
Title
Inflammatory markers
Description
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.
Time Frame
Change during 3 month of intervention compared with change during 3 month control period
Title
Illnesses and use of medicine
Description
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.
Time Frame
Change during 3 month of intervention compared with change during 3 month control period
Title
Use of ADHD medicine
Description
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.
Time Frame
Change during 3 month of intervention compared with change during 3 month control period
Title
General fatty acid composition of whole-blood
Description
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.
Time Frame
Change during 3 month of intervention compared with change during 3 month control period
Title
Reading proficiency
Description
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.
Time Frame
Change during 3 month of intervention compared with change during 3 month control period
Title
Mathematics proficiency
Description
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.
Time Frame
Change during 3 month of intervention compared with change during 3 month control period
Title
Learning
Description
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.
Time Frame
Change during 3 month of intervention compared with change during 3 month control period
Title
Wellness
Description
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.
Time Frame
Change during 3 month of intervention compared with change during 3 month control period
Title
Physical activity
Description
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.
Time Frame
Change during 3 month of intervention compared with change during 3 month control period
Title
Sleep
Description
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.
Time Frame
Change during 3 month of intervention compared with change during 3 month control period
Title
Fitness
Description
Fitness is measured using the Andersen test, which is an intermittent running test to estimate maximal oxygen uptake (mL*min-1*kg-1).
Time Frame
Change during 3 month of intervention compared with change during 3 month control period
Title
Dietary intake
Description
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.
Time Frame
Change during 3 month of intervention compared with change during 3 month control period
Title
Body weight and body mass index (BMI)
Description
Body weight (in kg, BMI and BMI z-score calculated on the basis of the current references from the World Health Organization (WHO)
Time Frame
Change during 3 month of intervention compared with change during 3 month control period
Title
Body composition
Description
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.
Time Frame
Change during 3 month of intervention compared with change during 3 month control period
Title
Appetite-regulating hormones
Description
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.
Time Frame
Change during 3 month of intervention compared with change during 3 month control period
Title
Vitamin D status
Description
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.
Time Frame
Baseline and change during 3 month of intervention compared with change during 3 month control period
Title
Bone Health
Description
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.
Time Frame
Change during 3 month of intervention compared with change during 3 month control period
Title
General fatty acid composition in whole-blood
Time Frame
Change during 3 month intervnetion compared with change during 3 month control period
Title
Iron status
Description
Whole-blood hemoglobin and serum ferritin will be used as measures of iron status
Time Frame
Change during 3 month intervention compared with 3 month control period
Title
Attention - other measures
Description
The following five measures from the attention test D2 will be used:
TN=Total Number of items processed E%=Percentage of errors
Time Frame
Change during 3 month of intervention compared with change during 3 month control period
Title
Omega-3 index in whole-blood
Description
The Omega-3 index in whole-blood is defined as the weight percentage of eicosapentaenoicacid + the weight percentage of docosahexaenoic acid in whole-blood
Time Frame
Change during 3 month of intervention compared with change during 3 month control period
Other Pre-specified Outcome Measures:
Title
Genotyping
Description
SNPs in genes related to metabolic pathways, messenger molecules, receptors or other genes that may affect efficacy measures in OPUS School Food Project
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
City
Copenhagen
ZIP/Postal Code
1958
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
28515069
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.
Results Reference
derived
PubMed Identifier
26764319
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.
Results Reference
derived
PubMed Identifier
25791747
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.
Results Reference
derived
PubMed Identifier
25532044
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.
Results Reference
derived
PubMed Identifier
25251317
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.
Results Reference
derived
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OPUS School Meal Study
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