The Effect of Nordic Recommended Diet on the Features of Metabolic Syndrome - Multicentre Study
NCT ID: NCT00992641
Last Updated: 2012-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
167 participants
INTERVENTIONAL
2009-08-31
2011-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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.
Control diet
Diet based on the information of the current dietary intake and food consumption in Nordic countries.
Control diet
Diet based on the information of the current dietary intake and food consumption in Nordic countries.
Interventions
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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.
Control diet
Diet based on the information of the current dietary intake and food consumption in Nordic countries.
Eligibility Criteria
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Inclusion Criteria
* BMI 27-38 kg/m2
* \+ two other IDF criteria for metabolic syndrome
* Anti-hypertensives and lipid-lowering medication are allowed
Exclusion Criteria
* 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
30 Years
65 Years
ALL
Yes
Sponsors
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University of Copenhagen
OTHER
Aarhus University Hospital
OTHER
University of Oulu
OTHER
University of Iceland
OTHER
Oslo and Akershus University College
OTHER
Uppsala University
OTHER
Lund University
OTHER
Marjukka Kolehmainen
OTHER
Responsible Party
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Marjukka Kolehmainen
Senior scientist
Principal Investigators
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Lars Dragsted, Prof
Role: PRINCIPAL_INVESTIGATOR
University of Copenhagen
Kjeld Hermansen, Prof
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital, Denmark
Kaisa Poutanen, Prof
Role: STUDY_DIRECTOR
University of Kuopio, Finland
Matti Uusitupa, Prof
Role: STUDY_DIRECTOR
University of Kuopio, Finland
Inga Thorsdottir, Prof
Role: PRINCIPAL_INVESTIGATOR
University of Iceland, Iceland
Markku Savolainen, Prof
Role: PRINCIPAL_INVESTIGATOR
University of Oulu, Finland
Karl-Heinz Herzig, Prof
Role: PRINCIPAL_INVESTIGATOR
University of Oulu, Finland
Stine M Ulven, Assoc prof
Role: PRINCIPAL_INVESTIGATOR
Akershus University College, Norway
Ulf Riserus, Prof
Role: PRINCIPAL_INVESTIGATOR
Uppsala University, Sweden
Björn Åkesson, Prof
Role: PRINCIPAL_INVESTIGATOR
Lund University
Peter Arner, Prof
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Matej Oresic, Prof
Role: PRINCIPAL_INVESTIGATOR
VTT Technical Research Centre, Finland
Kim Overvad, Prof
Role: PRINCIPAL_INVESTIGATOR
Aalborg Hospital, Denmark
Carsten Carlberg, Prof
Role: PRINCIPAL_INVESTIGATOR
University of Kuopio, Finland
Grether I Borge, Senior Scientist
Role: PRINCIPAL_INVESTIGATOR
Nofima Foods, Norway
Locations
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Aarhus University
Aarhus, , Denmark
University of Copenhagen
Copenhagen, , Denmark
University of Kuopio
Kuopio, , Finland
University of Oulu
Oulu, , Finland
University of Iceland
Reykjavik, , Iceland
Akershus University College
Akershus, , Norway
Lund University
Lund, , Sweden
Uppsala University
Uppsala, , Sweden
Countries
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References
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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.
Related Links
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NCoE SYSDIET internet pages
Other Identifiers
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31//2009
Identifier Type: -
Identifier Source: secondary_id
SYSDIET 070014
Identifier Type: -
Identifier Source: org_study_id
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