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

Primary Purpose

Abdominal Obesity, Insulin Resistance, Impaired Glucose Tolerance

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Experimental diet
Control diet
Sponsored by
Marjukka Kolehmainen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Abdominal Obesity focused on measuring Systems biology, Nutrition, Nordic diet, Dietary recommendations, Metabolic syndrome, Features of metabolic syndrome

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Aarhus University
  • University of Copenhagen
  • University of Kuopio
  • University of Oulu
  • University of Iceland
  • Akershus University College
  • Lund University
  • Uppsala University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental diet

Control diet

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Glucose metabolism
Glucose metabolism
Glucose metabolism

Secondary Outcome Measures

Transcriptomics and metabolomics data
Transcriptomics and metabolomics data
Transcriptomics and metabolomics data

Full Information

First Posted
October 7, 2009
Last Updated
April 16, 2012
Sponsor
Marjukka Kolehmainen
Collaborators
University of Copenhagen, Aarhus University Hospital, University of Oulu, University of Iceland, University Hospital, Akershus, Uppsala University, Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT00992641
Brief Title
The Effect of Nordic Recommended Diet on the Features of Metabolic Syndrome - Multicentre Study
Acronym
SYSDIET
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 Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marjukka Kolehmainen
Collaborators
University of Copenhagen, Aarhus University Hospital, University of Oulu, University of Iceland, University Hospital, Akershus, Uppsala University, Lund University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
167 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental diet
Arm Type
Experimental
Arm Description
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.
Arm Title
Control diet
Arm Type
Active Comparator
Arm Description
Diet based on the information of the current dietary intake and food consumption in Nordic countries.
Intervention Type
Other
Intervention Name(s)
Experimental diet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control diet
Intervention Description
Diet based on the information of the current dietary intake and food consumption in Nordic countries.
Primary Outcome Measure Information:
Title
Glucose metabolism
Time Frame
Study weeks 0
Title
Glucose metabolism
Time Frame
12 weeks
Title
Glucose metabolism
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Transcriptomics and metabolomics data
Time Frame
Study week 0
Title
Transcriptomics and metabolomics data
Time Frame
12 weeks
Title
Transcriptomics and metabolomics data
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Dragsted, Prof
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kjeld Hermansen, Prof
Organizational Affiliation
Aarhus University Hospital, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kaisa Poutanen, Prof
Organizational Affiliation
University of Kuopio, Finland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Matti Uusitupa, Prof
Organizational Affiliation
University of Kuopio, Finland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Inga Thorsdottir, Prof
Organizational Affiliation
University of Iceland, Iceland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Markku Savolainen, Prof
Organizational Affiliation
University of Oulu, Finland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karl-Heinz Herzig, Prof
Organizational Affiliation
University of Oulu, Finland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stine M Ulven, Assoc prof
Organizational Affiliation
Akershus University College, Norway
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ulf Riserus, Prof
Organizational Affiliation
Uppsala University, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Björn Åkesson, Prof
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Arner, Prof
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matej Oresic, Prof
Organizational Affiliation
VTT Technical Research Centre, Finland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kim Overvad, Prof
Organizational Affiliation
Aalborg Hospital, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carsten Carlberg, Prof
Organizational Affiliation
University of Kuopio, Finland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Grether I Borge, Senior Scientist
Organizational Affiliation
Nofima Foods, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University
City
Aarhus
Country
Denmark
Facility Name
University of Copenhagen
City
Copenhagen
Country
Denmark
Facility Name
University of Kuopio
City
Kuopio
ZIP/Postal Code
FIN-70211
Country
Finland
Facility Name
University of Oulu
City
Oulu
Country
Finland
Facility Name
University of Iceland
City
Reykjavik
Country
Iceland
Facility Name
Akershus University College
City
Akershus
Country
Norway
Facility Name
Lund University
City
Lund
Country
Sweden
Facility Name
Uppsala University
City
Uppsala
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
35007813
Citation
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.
Results Reference
derived
PubMed Identifier
31504116
Citation
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.
Results Reference
derived
PubMed Identifier
26962194
Citation
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.
Results Reference
derived
PubMed Identifier
25527767
Citation
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.
Results Reference
derived
PubMed Identifier
25340768
Citation
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.
Results Reference
derived
PubMed Identifier
25080537
Citation
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.
Results Reference
derived
PubMed Identifier
23398528
Citation
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.
Results Reference
derived
Links:
URL
http://www.sysdiet.fi/
Description
NCoE SYSDIET internet pages

Learn more about this trial

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

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