An observational study in Metabolic Syndrome X, sponsored by Arne Astrup. Completed at 1 site in Denmark. Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-06.
Sponsored by Arne Astrup · Observational
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.
2,011 studies on the registry are indexed under Metabolic Syndrome; 334 are open to participants now.
This study's enrollment of 834 is above the median of 200 across 469 observational studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →Arne Astrup is the lead sponsor of 8 studies on the registry; none are open to participants now.
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School children participating in OPUS School Meal Study (registered as an intervention study with protocol number: NCT01457794)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Baseline (cross-sectional)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Cross-sectional)
Iron status
Whole-blood hemoglobin and serum ferritin will be used as measures of iron status
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: cross-sectional (baseline)
Genotyping
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 (Cross-sectional)
The record gives a start of May 2011, a primary completion of Dec 2011 and a completion of Dec 2011. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Arne Astrup