The Effect of Nordic Recommended Diet on the Features of Metabolic Syndrome - Multicentre Study - Full Text View

Sponsor:	University of Eastern Finland
Collaborators:	University of Copenhagen Aarhus University Hospital University of Oulu University of Iceland Akershus University College Uppsala University Lund University
Information provided by:	University of Eastern Finland
ClinicalTrials.gov Identifier:	NCT00992641

Purpose

SYSDIET (Systems biology in controlled dietary interventions and cohort studies) is one of the three centres in the NCoE Food, Nutrition and Health, 2007-2011. It consists of 12 partners from five Nordic countries working on multidisciplinary fields of science related to nutritional biology. The main objective of SYSDIET is to reveal mechanisms by which Nordic foods and diets could be modified to promote health and prevent insulin resistance, type 2 diabetes and cardiovascular diseases, all of which being connected to metabolic syndrome. Furthermore, the aim is to build up a Nordic platform for cohort studies and carefully conducted multi-centre dietary intervention studies, where novel nutritional systems biology tools can be applied besides human studies also in animal and cell culture studies.In order to achieve the main objective a Nordic multi-centre randomized controlled human intervention study is being conducted in 2009-2010 in 6-8 centres of SYSDIET consortium.

Health of the Nordic populations has substantially improved during the last 30 years. This is due e.g. to marked decline in cardiovascular morbidity and mortality. However, during the last 10-20 years increasing obesity and sedentary lifestyle have resulted in an increase of metabolic syndrome and type 2 diabetes.

Having this background, the aim of the SYSDIET consortium is to carry out a controlled, randomized dietary intervention study in persons with features of metabolic syndrome to find out the effects of a healthy Nordic food on major abnormalities in metabolic syndrome.

Altogether 280-320 persons aged 30 to 65 years will be recruited from 6-8 centers (40-60 subjects/center) of the SYSDIET cohort. The main inclusion criterion is BMI 27-38 kg/m2. The subjects should also have at least two other IDF criteria for metabolic syndrome. Recruited persons will start the study by following their conventional diet for one month as a run-in period. After that subjects will be randomly assigned into Experimental- or Control-diet-group for 6 months. Experimental diet is rich in whole grain products, berries, fruits, vegetables and fish, and its fat intake is modified according to current Nordic recommendations. Control diet is based on the current information of the mean dietary intake and food consumption. The diets will be realised according to eating habits in each Nordic country.

Condition	Intervention
Abdominal Obesity Insulin Resistance Impaired Glucose Tolerance Type 2 Diabetes Cardiovascular Diseases	Other: Experimental diet Other: Control diet

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment
Official Title:	The Effect of Nordic Diet Rich in Whole Grain, Berries, Fruits, Vegetables and Fish on Features of Metabolic Syndrome - a Systems Biology Approach

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diets Obesity

U.S. FDA Resources

Further study details as provided by University of Eastern Finland:

Primary Outcome Measures:

Glucose metabolism [ Time Frame: Study weeks 0 ] [ Designated as safety issue: No ]
Glucose metabolism [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Glucose metabolism [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Transcriptomics and metabolomics data [ Time Frame: Study week 0 ] [ Designated as safety issue: No ]
Transcriptomics and metabolomics data [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Transcriptomics and metabolomics data [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	320
Study Start Date:	August 2009
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental diet: Experimental Diet based on Nordic recommendations: rich in whole grain products, berries, fruits and vegetables, recommended fat quality. Realised based on eating habits of each Nordic country.	Other: Experimental diet Diet based on Nordic recommendations: rich in whole grain products, berries, fruits and vegetables, recommended fat quality. Realised based on eating habits of each Nordic country.
Control diet: Active Comparator Diet based on the information of the current dietary intake and food consumption in Nordic countries.	Other: Control diet Diet based on the information of the current dietary intake and food consumption in Nordic countries.

Eligibility

Ages Eligible for Study:	30 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age 30-65 years
BMI 27-38 kg/m2
+ two other IDF criteria for metabolic syndrome
Anti-hypertensives and lipid-lowering medication are allowed

Exclusion Criteria:

Fasting plasma glucose > 7.0 mmol/l
Fasting plasma triglycerides > 3.0 mmol/l
Fasting plasma total cholesterol > 6.5 mmol/l
Blood pressure > 160/100 mmHg
Preceding weight change of 5% or more or active weight loss during preceding 6 months
Any disease or condition that may hamper the successful participation of the intervention: liver disease, kidney disease, diabetes (both type 1 and type 2), thyroid disease (Newly found unstabilized disease), Myocardial infarction within previous 6 months
Alcohol abuse (> 40 g/day), Oral corticosteroid therapy, severe psychiatric disorders, cancer under treatment, coeliac disease, Exceptional diets (Atkin's, vegan, allergies to fish or cereals, other extensive allergies), Binge eating - Unwillingness to discontinue the use of fish and vegetable oil or stanol and sterol ester supplements or products

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00992641

Contacts

Contact: Ursula S Schwab, Docent, Clinical Lecturer	+ 358 40 355 2791	ursula.schwab@uku.fi
Contact: Marjukka Kolehmainen, Docent, Senior Scientist	+ 358 40 355 3617	marjukka.kolehmainen@uku.fi

Locations

Denmark
University of Copenhagen	Not yet recruiting
Copenhagen, Denmark
Contact: Lars Dragsted, Prof +45 72332694 ldra@life.ku.dk
Principal Investigator: Lars Dragsted, Prof
Aarhus University	Not yet recruiting
Aarhus, Denmark
Contact: Kjeld Hermansen, Prof +45 24278475 kjeld.hermansen@aarhus.rm.dk
Principal Investigator: Kjeld Hermansen, Prof
Finland
University of Kuopio	Recruiting
Kuopio, Finland, FIN-70211
Contact: Ursula S Schwab, Docent, Clinical Lecturer +358 40 355 2791 ursula.schwab@uku.fi
Principal Investigator: Matti Uusitupa, Prof
University of Oulu	Not yet recruiting
Oulu, Finland
Contact: Markku Savolainen, Prof markku.savolainen@oulu.fi
Principal Investigator: Markku Savolainen, Prof
Iceland
University of Iceland	Recruiting
Reykjavik, Iceland
Contact: Inga Thorsdottir, Prof +354 543 8414 ingathor@landspitali.is
Principal Investigator: Inga Thordottir, Prof
Norway
Akershus University College	Not yet recruiting
Akershus, Norway
Contact: Stine M Ulven, Assoc prof +47 64849046 StineMarie.Ulven@hiak.no
Principal Investigator: Stine M Ulven, Assoc Prof
Sweden
Uppsala University	Not yet recruiting
Uppsala, Sweden
Contact: Ulf Riserus, Prof +46 186117971 ulf.riserus@pubcare.uu.se
Principal Investigator: Ulf riserus, Prof
Lund University	Recruiting
Lund, Sweden
Contact: Björn Åkesson, Prof +46 462224523 Bjorn.Akesson@tbiokem.lth.se
Principal Investigator: Björn Åkesson, Prof

Sponsors and Collaborators

University of Eastern Finland

University of Copenhagen

Aarhus University Hospital

University of Oulu

University of Iceland

Akershus University College

Uppsala University

Lund University

Investigators

Principal Investigator:	Lars Dragsted, Prof	University of Copenhagen
Principal Investigator:	Kjeld Hermansen, Prof	Aarhus University Hospital, Denmark
Study Director:	Kaisa Poutanen, Prof	University of Kuopio, Finland
Study Director:	Matti Uusitupa, Prof	University of Kuopio, Finland
Principal Investigator:	Inga Thorsdottir, Prof	University of Iceland, Iceland
Principal Investigator:	Markku Savolainen, Prof	University of Oulu, Finland
Principal Investigator:	Karl-Heinz Herzig, Prof	University of Oulu, Finland
Principal Investigator:	Stine M Ulven, Assoc prof	Akershus University College, Norway
Principal Investigator:	Ulf Riserus, Prof	Uppsala University, Sweden
Principal Investigator:	Björn Åkesson, Prof	Lund University
Principal Investigator:	Peter Arner, Prof	Karolinska Institutet
Principal Investigator:	Matej Oresic, Prof	VTT Technical Research Centre, Finland
Principal Investigator:	Kim Overvad, Prof	Aalborg Hospital, Denmark
Principal Investigator:	Carsten Carlberg, Prof	University of Kuopio, Finland
Principal Investigator:	Grether I Borge, Senior Scientist	Nofima Foods, Norway

More Information

Additional Information:

NCoE SYSDIET internet pages This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Kuopio ( Matti Uusitupa, Professor, rector )
Study ID Numbers:	SYSDIET 070014, 31//2009
Study First Received:	October 7, 2009
Last Updated:	October 9, 2009
ClinicalTrials.gov Identifier:	NCT00992641 History of Changes
Health Authority:	Finland: Ethics Committee

Keywords provided by University of Eastern Finland:

Systems biology
Nutrition
Nordic diet

Dietary recommendations
Metabolic syndrome
Features of metabolic syndrome

Additional relevant MeSH terms:

Obesity
Disease
Metabolic Diseases
Glucose Intolerance
Diabetes Mellitus
Endocrine System Diseases
Overweight
Body Weight
Signs and Symptoms
Hyperinsulinism

Hyperglycemia
Pathologic Processes
Syndrome
Diabetes Mellitus, Type 2
Nutrition Disorders
Cardiovascular Diseases
Overnutrition
Insulin Resistance
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010