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

April 16, 2012 updated by: Marjukka Kolehmainen

The Effect of Nordic Diet Rich in Whole Grain, Berries, Fruits, Vegetables and Fish on Features of Metabolic Syndrome - a Systems Biology Approach

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

167

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Aarhus, Denmark
        • Aarhus University
      • Copenhagen, Denmark
        • University of Copenhagen
      • Kuopio, Finland, FIN-70211
        • University of Kuopio
      • Oulu, Finland
        • University of Oulu
      • Reykjavik, Iceland
        • University of Iceland
      • Akershus, Norway
        • Akershus University College
      • Lund, Sweden
        • Lund University
      • Uppsala, Sweden
        • Uppsala University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Diet based on the information of the current dietary intake and food consumption in Nordic countries.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glucose metabolism
Time Frame: Study weeks 0
Study weeks 0
Glucose metabolism
Time Frame: 12 weeks
12 weeks
Glucose metabolism
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Transcriptomics and metabolomics data
Time Frame: Study week 0
Study week 0
Transcriptomics and metabolomics data
Time Frame: 12 weeks
12 weeks
Transcriptomics and metabolomics data
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

October 7, 2009

First Submitted That Met QC Criteria

October 8, 2009

First Posted (Estimate)

October 9, 2009

Study Record Updates

Last Update Posted (Estimate)

April 17, 2012

Last Update Submitted That Met QC Criteria

April 16, 2012

Last Verified

April 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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