Metabolic Syndrome XNCT01577277
OPUS School Meal Study - Cross Sectional Analyses From Baseline Investigations
An observational study of Metabolic Syndrome X, run by Arne Astrup at 1 site in Denmark.
Trial summary
The present study is based on cross-sectional data from the baseline investigations carried out in OPUS School Meal Study - a randomized crossover study carried out in 9 primary schools in Denmark 2011-2012. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome X
- How many people
- 834 participants
- Where
- 1 siteDenmark
- Study dates
- May 2011to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: School children participating in OPUS School Meal Study (registered as an intervention study with protocol number: NCT01457794)
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Denmark1 site
Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen Copenhagen, Denmark
Copenhagen, 1958
About this study
Official title: OPUS(Optimal Well-being, Development and Health for Danish Children Through a Healthy New Nordic Diet) School Meal Study - - Cross Sectional Analyses From Baseline Investigations
The present study is based on cross-sectional data from the baseline investigations carried out in OPUS School Meal Study - a randomized crossover study carried out in 9 primary schools in Denmark 2011-2012. Approximately 800 Danish school children from 3rd and 4th grades (8-12 year olds) took part in these baseline investigations of socioeconomic status, pubertal status, growth status, learning abilities, well-being, sleep, physical activity and risk markers of Cardiovascular Disease (CVD), type II diabetes and osteoporosis.
- 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
- Medical subject headings
- Metabolic Syndrome, Body Weight, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Cross-sectional)
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.
Measured: Baseline (Cross-sectional)
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).
Measured: Baseline (Cross-sectional)
Fatty acid composition in whole-blood
Content of saturated fatty acids, monounsaturated fatty acids, polyunsaturated fatty acids, total n-3 and n-6 polyunsaturated fatty acids, eicosapentaenoic acid, docosahexaenoic acid, and the n-6:n-3 ratio in whole-blood measured as weight% relative to the weight of total fatty acids.
Measured: Baseline (cross-sectional)
Secondary outcomes (20)
Body weight, Body Mass Index (BMI)
Body weight (in kg),BMI, BMI z-score calculated on the basis of the current references from WHO and body weight status (underweight/normal weight/overweight and obese) based on the age and gender specific iso BMI´s defined by Cole et al.
Cole et al. (2000) BMJ 320 (7244): 1240-1243. Cole et al. (2007) BMJ 335 (7612): 194-197.
Measured: Baseline (Cross-sectional)
Physical activity
Physical activity is measured using waist-worn ActiGraph GT3X and GT3X+. Outcome measures will be counts/min, time spent in sedentary, light, moderate and vigorous activities. The participant are asked to note down non-wear periods in a logbook - mainly to increase compliance - and to note the amount of bicycling and if the child was sick within the measurement period. Questions regarding TV-watching, playing with videogames and physical activity, will help identify activity-pattern.
Measured: Baseline (Cross-sectional)
Sleep
Sleep is measured using ActiGraph GT3X and GT3X+ 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 quality will be derived from these actigraphy measurements. In addition, the abbreviated version of the Children's Sleep Habits Questionnaire (CSHQ) is used to identify sleep problems.
Measured: Baseline (Cross-sectional)
Cardio-respiratory fitness
Cardio-respiratory fitness is measured using the Andersen test, which is a 10-min intermittent running test to estimate maximal oxygen uptake (mL*min-1*kg-1).
Measured: Baseline (Cross-sectional)
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.
Measured: Baseline (Cross-sectional)
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.
Measured: Baseline (cross-sectional)
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.
Measured: Baseline (Cross-sectional)
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.
Measured: Baseline (Cross-sectional)
Iron status
Whole-blood hemoglobin and serum ferritin will be used as measures of iron status
Measured: Baseline (Cross-sectional)
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
Measured: Baseline (Cross-sectional)
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.
Measured: Baseline (Cross-sectional)
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.
Measured: Baseline (Cross-sectional)
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.
Measured: Baseline (Cross-sectional)
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.
Measured: Baseline (Cross-sectional)
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.
Measured: Baseline (Cross-sectional)
Illnesses and use of medicine
Self-reported data collected by personal computer-assisted questionnaire interview with the parents. 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.
Measured: Baseline (Cross-sectional)
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-reative Proetin (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.
Measured: Baseline (Cross-sectional)
Socioeconomic measures
Self-reported data collected by personal computer-assisted questionnaire interview with the parents. Data are computed on household level. For education and occupation household level = level for the parent or cohabiting partner with the highest value. Education is computed as years of education and as education type. The occupation categorisation is based on the system SOCIO used by Statistics Denmark.
Measured: Baseline (Cross-sectional)
Early Cardiovascular Risk Markers
Systolic and diastolic blood pressure, serum blood cholesterol (total, LDL, VLDL and HDL) and triglyceride, plasma glucose, serum insulin and the HOMA index.
Measured: Baseline (Cross-sectional)
Pubertal status
Pubertal status is assessed by menstruation status (menstruation started or not) and breast development in girls (Tanner stage 1-5) and by development of pubic hair in boys (Tanner stage 1-5).
Measured: cross-sectional (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study startMay 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 834 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arne Astrup
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Denmark, University of Aarhus, University Hospital, Gentofte, Copenhagen
- Responsible party
- Sponsor-investigator, Arne Astrup, University of Copenhagen
- Investigators
- Kim F Michaelsen, Professor MD, Principal investigator, Department of Human Nutrition, Faculty of Science, University of Copenhagen Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577277
- Sponsor's protocol ID
- D208 baseline
- Other IDs
- H-1-2010-124
- Status last verified
- Mar 2017
- First submitted
- 11 Apr 2012
- Last updated
- 6 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Damsgaard CT, Biltoft-Jensen A, Tetens I, Michaelsen KF, Lind MV, Astrup A, Landberg R. Whole-Grain Intake, Reflected by Dietary Records and Biomarkers, Is Inversely Associated with Circulating Insulin and Other Cardiometabolic Markers in 8- to 11-Year-Old Children. J Nutr. 2017 May;147(5):816-824. doi: 10.3945/jn.116.244624. Epub 2017 Mar 29.
PubMed 28356426
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPUS(Optimal Well-being, Development and Health for Danish Children Through a Healthy New Nordic Diet) School Meal Study - - Cross Sectional Analyses From Baseline Investigations
- ClinicalTrials.gov ID
- NCT01577277
- Acronym / sponsor ID
- D208 baseline
- Conditions
- Metabolic Syndrome X
- Keywords
- Metabolic Syndrome X, Fatty Acids, Omega-3, Learning, Attention, Nutritional Status, Nutrition Assessments, Body Weight, Physical Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 834 participants (actual)
- Lead sponsor
- Arne AstrupUniversity, hospital or other
- Collaborators
- Technical University of Denmark, University of Aarhus, University Hospital, Gentofte, Copenhagen
- Study start
- May 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 13 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study is based on cross-sectional data from the baseline investigations carried out in OPUS School Meal Study - a randomized crossover study carried out in 9 primary schools in Denmark 2011-2012. Approximately 800 Danish school children from 3rd and 4th grades (8-12 year olds) took part in these baseline investigations of socioeconomic status, pubertal status, growth status, learning abilities, well-being, sleep, physical activity and risk markers of Cardiovascular Disease (CVD), type II diabetes and osteoporosis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- School children participating in OPUS School Meal Study (registered as an intervention study with protocol number: NCT01457794)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Metabolic syndrome score
Time frame: Baseline (Cross-sectional)
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.
Body composition
Time frame: Baseline (Cross-sectional)
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.
Concentration Performance
Time frame: Baseline (Cross-sectional)
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).
Fatty acid composition in whole-blood
Time frame: Baseline (cross-sectional)
Content of saturated fatty acids, monounsaturated fatty acids, polyunsaturated fatty acids, total n-3 and n-6 polyunsaturated fatty acids, eicosapentaenoic acid, docosahexaenoic acid, and the n-6:n-3 ratio in whole-blood measured as weight% relative to the weight of total fatty acids.
20 secondary outcomes
Body weight, Body Mass Index (BMI)
Time frame: Baseline (Cross-sectional)
Physical activity
Time frame: Baseline (Cross-sectional)
Sleep
Time frame: Baseline (Cross-sectional)
Cardio-respiratory fitness
Time frame: Baseline (Cross-sectional)
Dietary intake
Time frame: Baseline (Cross-sectional)
Appetite-regulating hormones
Time frame: Baseline (cross-sectional)
Vitamin D status
Time frame: Baseline (Cross-sectional)
Bone Health
Time frame: Baseline (Cross-sectional)
Iron status
Time frame: Baseline (Cross-sectional)
Attention - other measures
Time frame: Baseline (Cross-sectional)
Wellness
Time frame: Baseline (Cross-sectional)
Learning
Time frame: Baseline (Cross-sectional)
Mathematics proficiency
Time frame: Baseline (Cross-sectional)
Reading proficiency
Time frame: Baseline (Cross-sectional)
Use of ADHD medicine
Time frame: Baseline (Cross-sectional)
Illnesses and use of medicine
Time frame: Baseline (Cross-sectional)
Inflammatory markers
Time frame: Baseline (Cross-sectional)
Socioeconomic measures
Time frame: Baseline (Cross-sectional)
Early Cardiovascular Risk Markers
Time frame: Baseline (Cross-sectional)
Pubertal status
Time frame: cross-sectional (baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
- Derived from this study: PubMed 28356426Damsgaard CT, Biltoft-Jensen A, Tetens I, Michaelsen KF, Lind MV, Astrup A, Landberg R. Whole-Grain Intake, Reflected by Dietary Records and Biomarkers, Is Inversely Associated with Circulating Insulin and Other Cardiometabolic Markers in 8- to 11-Year-Old Children. J Nutr. 2017 May;147(5):816-824. doi: 10.3945/jn.116.244624. Epub 2017 Mar 29.
- Research group homepageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim F Michaelsen, Professor MD principal investigator
Department of Human Nutrition, Faculty of Science, University of Copenhagen Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome X, run by Arne Astrup at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic syndrome score (time frame: Baseline (Cross-sectional)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01577277, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2017.