Metabolic Syndrome XNCT01457794
OPUS School Meal Study
A study testing School meals based on the principles of the New Nordic Diet in people with Metabolic Syndrome X, run by Arne Astrup at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome X
- What is being tested?
- School meals based on the principles of the New Nordic Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 834 participants
- Where
- 1 siteDenmark
- Study dates
- May 2011to Jun 2012
- Phase
- Interventional
- 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 11 years
- All sexes
- Healthy volunteers accepted
- Child
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, 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
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.
- Conditions
- Metabolic Syndrome X
- Being tested
- School meals based on the principles of the New Nordic Diet
- 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 participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School meals based on the principles of the New Nordic DietOther
The study participants are provided with three daily school meals for 3 month
| Study group | Role | What they receive |
|---|---|---|
| NewNordicDiet first | Other | Intervention with NND for 3 mo then no intervention for 3 mo Receives: Other: School meals based on the principles of the New Nordic Diet |
| NewNordicDiet last | Other | No intervention for 3 mo and then intervention with NND for 3 mo Receives: Other: School meals based on the principles of the New Nordic Diet |
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 at baseline.
Measured: Change during 3 month of intervention compared with change during 3 month control period
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: Change during 3 month of intervention compared with change during 3 month control period
Secondary outcomes (23)
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.
Measured: Change during 3 month of intervention compared with change during 3 month control period
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.
Measured: Change during 3 month of intervention compared with change during 3 month control period
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.
Measured: Change during 3 month of intervention compared with change during 3 month control period
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.
Measured: Change during 3 month of intervention compared with change during 3 month control period
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: Change during 3 month of intervention compared with change during 3 month control period
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.
Measured: Change during 3 month of intervention compared with change during 3 month control period
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: Change during 3 month of intervention compared with change during 3 month control period
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: Change during 3 month of intervention compared with change during 3 month control period
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: Change during 3 month of intervention compared with change during 3 month control period
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: Change during 3 month of intervention compared with change during 3 month control period
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.
Measured: Change during 3 month of intervention compared with change during 3 month control period
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.
Measured: Change during 3 month of intervention compared with change during 3 month control period
Fitness
Fitness is measured using the Andersen test, which is an intermittent running test to estimate maximal oxygen uptake (mL*min-1*kg-1).
Measured: Change during 3 month of intervention compared with change during 3 month control period
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: Change during 3 month of intervention compared with change during 3 month control period
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)
Measured: Change during 3 month of intervention compared with change during 3 month control period
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: Change during 3 month of intervention compared with change during 3 month control period
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: Change during 3 month of intervention compared with change during 3 month control period
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 and change during 3 month of intervention compared with change during 3 month control period
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: Change during 3 month of intervention compared with change during 3 month control period
General fatty acid composition in whole-blood
Measured: Change during 3 month intervnetion compared with change during 3 month control period
Iron status
Whole-blood hemoglobin and serum ferritin will be used as measures of iron status
Measured: Change during 3 month intervention compared with 3 month control period
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: Change during 3 month of intervention compared with change during 3 month control period
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
Measured: Change during 3 month of intervention compared with change during 3 month control period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457794
- Sponsor's protocol ID
- D208
- Other IDs
- H-1-2010-124
- Status last verified
- Mar 2017
- First submitted
- 20 Oct 2011
- Last updated
- 6 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28515069Biltoft-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.
PubMed 26764319Sorensen 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.
PubMed 25791747Dalskov 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.
PubMed 25532044Hjorth 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.
PubMed 25251317
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
- ClinicalTrials.gov ID
- NCT01457794
- Acronym / sponsor ID
- D208
- Conditions
- Metabolic Syndrome X
- Keywords
- Metabolic Syndrome X, Fatty Acids, Omega-3, Learning, Attention, Nutritional Status, Nutrition Assessments, Body Weight, Physical Activity
- Study type
- Interventional
- 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
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 24 Oct 2011 (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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NewNordicDiet first | Other | Other: School meals based on the principles of the New Nordic DietIntervention with NND for 3 mo then no intervention for 3 mo |
| NewNordicDiet last | Other | Other: School meals based on the principles of the New Nordic DietNo intervention for 3 mo and then intervention with NND for 3 mo |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| School meals based on the principles of the New Nordic DietThe study participants are provided with three daily school meals for 3 month | Other | NewNordicDiet first, NewNordicDiet last |
Primary outcome
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.
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).
23 secondary outcomes
Early Cardiovascular Risk Markers
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Other metabolic syndrome scores
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Inflammatory markers
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Illnesses and use of medicine
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Use of ADHD medicine
Time frame: Change during 3 month of intervention compared with change during 3 month control period
General fatty acid composition of whole-blood
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Reading proficiency
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Mathematics proficiency
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Learning
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Wellness
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Physical activity
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Sleep
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Fitness
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Dietary intake
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Body weight and body mass index (BMI)
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Body composition
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Appetite-regulating hormones
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Vitamin D status
Time frame: Baseline and change during 3 month of intervention compared with change during 3 month control period
Bone Health
Time frame: Change during 3 month of intervention compared with change during 3 month control period
General fatty acid composition in whole-blood
Time frame: Change during 3 month intervnetion compared with change during 3 month control period
Iron status
Time frame: Change during 3 month intervention compared with 3 month control period
Attention - other measures
Time frame: Change during 3 month of intervention compared with change during 3 month control period
Omega-3 index in whole-blood
Time frame: Change during 3 month of intervention compared with change during 3 month control period
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 28515069Lauritzen 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.
- Derived from this study: PubMed 26764319Biltoft-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.
- Derived from this study: PubMed 25791747Sorensen 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.
- Derived from this study: PubMed 25532044Dalskov 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.
- Derived from this study: PubMed 25251317Hjorth 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.
- Researchgroup 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing School meals based on the principles of the New Nordic Diet in people with 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 4 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: Change during 3 month of intervention compared with change during 3 month control period). The study lists 2 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 NCT01457794, which also lists 5 linked publications.
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.