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| 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 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 |
|---|---|
|
Obesity, Abdominal Insulin Resistance Impaired Glucose Tolerance Diabetes Mellitus, Non-Insulin-Dependent 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 |
| Enrollment: | 167 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | March 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.
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
| 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
| Responsible Party: | Matti Uusitupa, Professor, 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: | March 4, 2011 |
| Health Authority: | Finland: Ethics Committee |
|
Systems biology Nutrition Nordic diet |
Dietary recommendations Metabolic syndrome Features of metabolic syndrome |
|
Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Insulin Resistance Obesity Glucose Intolerance Obesity, Abdominal Metabolic Syndrome X Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Hyperinsulinism Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Hyperglycemia |
