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

NCT00992641 | Completed

• 2 other identifiers: SYSDIET 07001431//2009
• Study Type: interventional
• Target: 167
• Locations: 5 countries
• Sites: 8

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.

Conditions

Abdominal Obesity; Insulin Resistance; Impaired Glucose Tolerance; Type 2 Diabetes; Cardiovascular Diseases

Keywords

Systems biology; Nutrition; Nordic diet; Dietary recommendations; Metabolic syndrome; Features of metabolic syndrome

Outcome Measures

Primary Outcomes (3)

• Glucose metabolism

  Study weeks 0

• Glucose metabolism

  12 weeks

• Glucose metabolism

  24 weeks

Secondary Outcomes (3)

• Transcriptomics and metabolomics data

  Study week 0

• Transcriptomics and metabolomics data

  12 weeks

• Transcriptomics and metabolomics data

  24 weeks

Study Arms (2)

Experimental diet

EXPERIMENTAL

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

Control diet

ACTIVE COMPARATOR

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

Other: Control diet

Interventions

Experimental diet OTHER

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

Control diet OTHER

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

Control diet

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marjukka Kolehmainen: lead
• University of Copenhagen: collaborator
• Aarhus University Hospital: collaborator
• University of Oulu: collaborator
• University of Iceland: collaborator
• Oslo and Akershus University College: collaborator
• Uppsala University: collaborator
• Lund University: collaborator

Study Sites (8)

Aarhus University

Aarhus, Denmark

Location

University of Copenhagen

Copenhagen, Denmark

Location

University of Kuopio

Kuopio, FIN-70211, Finland

Location

University of Oulu

Oulu, Finland

Location

University of Iceland

Reykjavik, Iceland

Location

Akershus University College

Akershus, Norway

Location

Lund University

Lund, Sweden

Location

Uppsala University

Uppsala, Sweden

Location

Related Publications (7)

• 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.

  PMID: 35007813 DERIVED

• 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.

  PMID: 31504116 DERIVED

• 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.

  PMID: 26962194 DERIVED

• 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.

  PMID: 25527767 DERIVED

• 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.

  PMID: 25340768 DERIVED

• 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.

  PMID: 25080537 DERIVED

• 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.

  PMID: 23398528 DERIVED

Related Links

• NCoE SYSDIET internet pages

MeSH Terms

Conditions

Obesity, Abdominal; Insulin Resistance; Glucose Intolerance; Diabetes Mellitus, Type 2; Cardiovascular Diseases; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Lars Dragsted, Prof

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

• Kjeld Hermansen, Prof

  Aarhus University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

• Kaisa Poutanen, Prof

  University of Kuopio, Finland

  STUDY DIRECTOR

• Matti Uusitupa, Prof

  University of Kuopio, Finland

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior scientist

Study Record Dates

• First Submitted: October 7, 2009
• First Posted: October 9, 2009
• Study Start: August 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2011
• Last Updated: April 17, 2012

Record last verified: 2012-04

Locations

NO (1); FI (2); IC (1); DK (2); SE (2)