OPUS School Meal Study

Metabolic Syndrome X Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01457794
• Other study ID #: D208
• Secondary ID: H-1-2010-124
• Status: Completed
• Phase: N/A
• First received: October 20, 2011
• Last updated: March 3, 2017
• Start date: May 2011
• Est. completion date: June 2012

Study information

• Verified date: March 2017
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 834
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome X

Intervention

Other:
• School meals based on the principles of the New Nordic Diet
The study participants are provided with three daily school meals for 3 month

Locations

Country	Name	City	State
Denmark	Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen	Copenhagen

Sponsors (4)

Lead Sponsor	Collaborator
Arne Astrup	Technical University of Denmark, University Hospital, Gentofte, Copenhagen, University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Genotyping	SNPs in genes related to metabolic pathways, messenger molecules, receptors or other genes that may affect efficacy measures in OPUS School Food Project	Baseline
Primary	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.	Change during 3 month of intervention compared with change during 3 month control period
Primary	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).	Change during 3 month of intervention compared with change during 3 month control period
Secondary	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.	Change during 3 month of intervention compared with change during 3 month control period
Secondary	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.	Change during 3 month of intervention compared with change during 3 month control period
Secondary	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.	Change during 3 month of intervention compared with change during 3 month control period
Secondary	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.	Change during 3 month of intervention compared with change during 3 month control period
Secondary	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.	Change during 3 month of intervention compared with change during 3 month control period
Secondary	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.	Change during 3 month of intervention compared with change during 3 month control period
Secondary	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.	Change during 3 month of intervention compared with change during 3 month control period
Secondary	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.	Change during 3 month of intervention compared with change during 3 month control period
Secondary	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.	Change during 3 month of intervention compared with change during 3 month control period
Secondary	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.	Change during 3 month of intervention compared with change during 3 month control period
Secondary	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.	Change during 3 month of intervention compared with change during 3 month control period
Secondary	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.	Change during 3 month of intervention compared with change during 3 month control period
Secondary	Fitness	Fitness is measured using the Andersen test, which is an intermittent running test to estimate maximal oxygen uptake (mL*min-1*kg-1).	Change during 3 month of intervention compared with change during 3 month control period
Secondary	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.	Change during 3 month of intervention compared with change during 3 month control period
Secondary	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)	Change during 3 month of intervention compared with change during 3 month control period
Secondary	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.	Change during 3 month of intervention compared with change during 3 month control period
Secondary	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.	Change during 3 month of intervention compared with change during 3 month control period
Secondary	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.	Baseline and change during 3 month of intervention compared with change during 3 month control period
Secondary	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.	Change during 3 month of intervention compared with change during 3 month control period
Secondary	General fatty acid composition in whole-blood		Change during 3 month intervnetion compared with change during 3 month control period
Secondary	Iron status	Whole-blood hemoglobin and serum ferritin will be used as measures of iron status	Change during 3 month intervention compared with 3 month control period
Secondary	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	Change during 3 month of intervention compared with change during 3 month control period
Secondary	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	Change during 3 month of intervention compared with change during 3 month control period

External Links

•   Researchgroup homepage
•   Study homepage