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

Sponsor

Marjukka Kolehmainen (Other)

Overall Status

Completed

CT.gov ID

NCT00992641

Collaborator

University of Copenhagen (Other), Aarhus University Hospital (Other), University of Oulu (Other), University of Iceland (Other), University Hospital, Akershus (Other), Uppsala University (Other), Lund University (Other)

167

Enrollment

Locations

Arms

Duration (Months)

20.9

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Obesity Insulin Resistance Impaired Glucose Tolerance Type 2 Diabetes Cardiovascular Diseases	Other: Experimental diet Other: Control diet	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

167 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Aug 1, 2009

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

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.	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.

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.

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.

Outcome Measures

Primary Outcome Measures

Glucose metabolism [Study weeks 0]
Glucose metabolism [12 weeks]
Glucose metabolism [24 weeks]

Secondary Outcome Measures

Transcriptomics and metabolomics data [Study week 0]
Transcriptomics and metabolomics data [12 weeks]
Transcriptomics and metabolomics data [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	Country	Postal Code
1	Aarhus University	Aarhus	Denmark
2	University of Copenhagen	Copenhagen	Denmark
3	University of Kuopio	Kuopio	Finland	FIN-70211
4	University of Oulu	Oulu	Finland
5	University of Iceland	Reykjavik	Iceland
6	Akershus University College	Akershus	Norway
7	Lund University	Lund	Sweden
8	Uppsala University	Uppsala	Sweden

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