The Effect of Nordic Recommended Diet on the Features of Metabolic Syndrome - Multicentre Study (SYSDIET)

This study has been completed.
Sponsor:
Collaborators:
University of Copenhagen
Aarhus University Hospital
University of Oulu
University of Iceland
Akershus University College
Uppsala University
Lund University
Information provided by (Responsible Party):
Marjukka Kolehmainen, University of Eastern Finland
ClinicalTrials.gov Identifier:
NCT00992641
First received: October 7, 2009
Last updated: April 16, 2012
Last verified: April 2012
  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 167 persons aged 30 to 65 years were 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 realized 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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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:


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 ]

Enrollment: 167
Study Start Date: August 2009
Study Completion Date: December 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Active Comparator: Control diet
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.

Detailed Description:

Substudy of the multicentre SYSDIET-study has been conducted in one of the centres, Aarhus, Denmark.

This study aims was determine if a "Healthy Nordic Diet (HND)" fulfilling the Nordic Nutrition Recommendations does affect 24-h ambulatory BP in subjects with features of Metabolic Syndrome. Of the 167 SYSDIET subjects with MeS, 37 were enrolled in a Danish sub study on 24-h ambulatory BP performed at 0 and 12 wks after randomization. 32 completed the sub study. All maintained stable body weight, physical activity level, medicine, and alcohol habits during the intervention, as prescribed.

  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 old
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Denmark
Aarhus University
Aarhus, Denmark
University of Copenhagen
Copenhagen, Denmark
Finland
University of Kuopio
Kuopio, Finland, FIN-70211
University of Oulu
Oulu, Finland
Iceland
University of Iceland
Reykjavik, Iceland
Norway
Akershus University College
Akershus, Norway
Sweden
Lund University
Lund, Sweden
Uppsala University
Uppsala, Sweden
Sponsors and Collaborators
Marjukka Kolehmainen
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:
No publications provided by University of Eastern Finland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marjukka Kolehmainen, Senior scientist, University of Eastern Finland
ClinicalTrials.gov Identifier: NCT00992641     History of Changes
Other Study ID Numbers: SYSDIET 070014, 31//2009
Study First Received: October 7, 2009
Last Updated: April 16, 2012
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:
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Syndrome
Metabolic Syndrome X
Insulin Resistance
Glucose Intolerance
Obesity, Abdominal
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Disease
Pathologic Processes
Hyperinsulinism
Hyperglycemia
Obesity
Overnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on September 15, 2014