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

NCT00992641 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2012-04-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

OTHER

Control diet

Diet based on the information of the current dietary intake and food consumption in Nordic countries.

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER
  • Aarhus University Hospital

    collaborator OTHER
  • University of Oulu

    collaborator OTHER
  • University of Iceland

    collaborator OTHER
  • Oslo and Akershus University College

    collaborator OTHER
  • Uppsala University

    collaborator OTHER
  • Lund University

    collaborator OTHER
  • Marjukka Kolehmainen

    lead OTHER

Principal Investigators

  • Lars Dragsted, Prof · University of Copenhagen

  • Kjeld Hermansen, Prof · Aarhus University Hospital, Denmark

  • Kaisa Poutanen, Prof · University of Kuopio, Finland

  • Matti Uusitupa, Prof · University of Kuopio, Finland

  • Inga Thorsdottir, Prof · University of Iceland, Iceland

  • Markku Savolainen, Prof · University of Oulu, Finland

  • Karl-Heinz Herzig, Prof · University of Oulu, Finland

  • Stine M Ulven, Assoc prof · Akershus University College, Norway

  • Ulf Riserus, Prof · Uppsala University, Sweden

  • Björn Åkesson, Prof · Lund University

  • Peter Arner, Prof · Karolinska Institutet

  • Matej Oresic, Prof · VTT Technical Research Centre, Finland

  • Kim Overvad, Prof · Aalborg Hospital, Denmark

  • Carsten Carlberg, Prof · University of Kuopio, Finland

  • Grether I Borge, Senior Scientist · Nofima Foods, Norway

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-11-30
Completion
2011-12-31

Countries

  • Denmark
  • Finland
  • Iceland
  • Norway
  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00992641 on ClinicalTrials.gov