- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00992641
The Effect of Nordic Recommended Diet on the Features of Metabolic Syndrome - Multicentre Study (SYSDIET)
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
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Aarhus, Denmark
- Aarhus University
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Copenhagen, Denmark
- University of Copenhagen
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Kuopio, Finland, FIN-70211
- University of Kuopio
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Oulu, Finland
- University of Oulu
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Reykjavik, Iceland
- University of Iceland
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Akershus, Norway
- Akershus University College
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Lund, Sweden
- Lund University
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Uppsala, Sweden
- Uppsala University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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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.
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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.
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Active Comparator: Control diet
Diet based on the information of the current dietary intake and food consumption in Nordic countries.
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Diet based on the information of the current dietary intake and food consumption in Nordic countries.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Glucose metabolism
Time Frame: Study weeks 0
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Study weeks 0
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Glucose metabolism
Time Frame: 12 weeks
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12 weeks
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Glucose metabolism
Time Frame: 24 weeks
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24 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Transcriptomics and metabolomics data
Time Frame: Study week 0
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Study week 0
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Transcriptomics and metabolomics data
Time Frame: 12 weeks
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12 weeks
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Transcriptomics and metabolomics data
Time Frame: 24 weeks
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24 weeks
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Collaborators and Investigators
Sponsor
Collaborators
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
General Publications
- Gurdeniz G, Uusitupa M, Hermansen K, Savolainen MJ, Schwab U, Kolehmainen M, Brader L, Cloetens L, Herzig KH, Hukkanen J, Rosqvist F, Ulven SM, Gunnarsdottir I, Thorsdottir I, Oresic M, Poutanen KS, Riserus U, Akesson B, Dragsted LO. Analysis of the SYSDIET Healthy Nordic Diet randomized trial based on metabolic profiling reveal beneficial effects on glucose metabolism and blood lipids. Clin Nutr. 2022 Feb;41(2):441-451. doi: 10.1016/j.clnu.2021.12.031. Epub 2021 Dec 25.
- Tuomainen M, Karkkainen O, Leppanen J, Auriola S, Lehtonen M, Savolainen MJ, Hermansen K, Riserus U, Akesson B, Thorsdottir I, Kolehmainen M, Uusitupa M, Poutanen K, Schwab U, Hanhineva K. Quantitative assessment of betainized compounds and associations with dietary and metabolic biomarkers in the randomized study of the healthy Nordic diet (SYSDIET). Am J Clin Nutr. 2019 Nov 1;110(5):1108-1118. doi: 10.1093/ajcn/nqz179.
- Lankinen M, Schwab U, Kolehmainen M, Paananen J, Nygren H, Seppanen-Laakso T, Poutanen K, Hyotylainen T, Riserus U, Savolainen MJ, Hukkanen J, Brader L, Marklund M, Rosqvist F, Hermansen K, Cloetens L, Onning G, Thorsdottir I, Gunnarsdottir I, Akesson B, Dragsted LO, Uusitupa M, Oresic M. A Healthy Nordic Diet Alters the Plasma Lipidomic Profile in Adults with Features of Metabolic Syndrome in a Multicenter Randomized Dietary Intervention. J Nutr. 2015 Apr 1;146(4):662-672. doi: 10.3945/jn.115.220459.
- Kolehmainen M, Ulven SM, Paananen J, de Mello V, Schwab U, Carlberg C, Myhrstad M, Pihlajamaki J, Dungner E, Sjolin E, Gunnarsdottir I, Cloetens L, Landin-Olsson M, Akesson B, Rosqvist F, Hukkanen J, Herzig KH, Dragsted LO, Savolainen MJ, Brader L, Hermansen K, Riserus U, Thorsdottir I, Poutanen KS, Uusitupa M, Arner P, Dahlman I. Healthy Nordic diet downregulates the expression of genes involved in inflammation in subcutaneous adipose tissue in individuals with features of the metabolic syndrome. Am J Clin Nutr. 2015 Jan;101(1):228-39. doi: 10.3945/ajcn.114.092783. Epub 2014 Nov 19.
- Magnusdottir OK, Landberg R, Gunnarsdottir I, Cloetens L, Akesson B, Rosqvist F, Schwab U, Herzig KH, Hukkanen J, Savolainen MJ, Brader L, Hermansen K, Kolehmainen M, Poutanen K, Uusitupa M, Riserus U, Thorsdottir I. Whole grain rye intake, reflected by a biomarker, is associated with favorable blood lipid outcomes in subjects with the metabolic syndrome--a randomized study. PLoS One. 2014 Oct 23;9(10):e110827. doi: 10.1371/journal.pone.0110827. eCollection 2014.
- Marklund M, Magnusdottir OK, Rosqvist F, Cloetens L, Landberg R, Kolehmainen M, Brader L, Hermansen K, Poutanen KS, Herzig KH, Hukkanen J, Savolainen MJ, Dragsted LO, Schwab U, Paananen J, Uusitupa M, Akesson B, Thorsdottir I, Riserus U. A dietary biomarker approach captures compliance and cardiometabolic effects of a healthy Nordic diet in individuals with metabolic syndrome. J Nutr. 2014 Oct;144(10):1642-9. doi: 10.3945/jn.114.193771. Epub 2014 Jul 30.
- Uusitupa M, Hermansen K, Savolainen MJ, Schwab U, Kolehmainen M, Brader L, Mortensen LS, Cloetens L, Johansson-Persson A, Onning G, Landin-Olsson M, Herzig KH, Hukkanen J, Rosqvist F, Iggman D, Paananen J, Pulkki KJ, Siloaho M, Dragsted L, Barri T, Overvad K, Bach Knudsen KE, Hedemann MS, Arner P, Dahlman I, Borge GI, Baardseth P, Ulven SM, Gunnarsdottir I, Jonsdottir S, Thorsdottir I, Oresic M, Poutanen KS, Riserus U, Akesson B. Effects of an isocaloric healthy Nordic diet on insulin sensitivity, lipid profile and inflammation markers in metabolic syndrome -- a randomized study (SYSDIET). J Intern Med. 2013 Jul;274(1):52-66. doi: 10.1111/joim.12044. Epub 2013 Mar 2.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYSDIET 070014
- 31//2009
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