Clinical trial NCT00992641: The Effect of Nordic Recommended Diet on the Features of Metabolic Syndrome - Multicentre Study
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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Eastern Finland
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Aarhus University Hospital
name: University of Oulu
name: University of Iceland
name: Oslo and Akershus University College
name: Uppsala University
name: Lund University
First posted: 2009-10-09
Enrollment: 167
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Glucose metabolism
timeFrame: Study weeks 0
measure: Glucose metabolism
timeFrame: 12 weeks
measure: Glucose metabolism
timeFrame: 24 weeks
Secondary outcomes:
measure: Transcriptomics and metabolomics data
timeFrame: Study week 0
measure: Transcriptomics and metabolomics data
timeFrame: 12 weeks
measure: Transcriptomics and metabolomics data
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University
city: Copenhagen
country: Denmark
facility: University of Copenhagen
city: Kuopio
country: Finland
facility: University of Kuopio
city: Oulu
country: Finland
facility: University of Oulu
city: Reykjavik
country: Iceland
facility: University of Iceland
city: Akershus
country: Norway
facility: Akershus University College
city: Lund
country: Sweden
facility: Lund University
city: Uppsala
country: Sweden
facility: Uppsala University
Study officials:
affiliation: University of Copenhagen
name: Lars Dragsted, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University Hospital, Denmark
name: Kjeld Hermansen, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kuopio, Finland
name: Kaisa Poutanen, Prof
role: STUDY_DIRECTOR
affiliation: University of Kuopio, Finland
name: Matti Uusitupa, Prof
role: STUDY_DIRECTOR
affiliation: University of Iceland, Iceland
name: Inga Thorsdottir, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oulu, Finland
name: Markku Savolainen, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oulu, Finland
name: Karl-Heinz Herzig, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Akershus University College, Norway
name: Stine M Ulven, Assoc prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Uppsala University, Sweden
name: Ulf Riserus, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Lund University
name: Björn Åkesson, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Peter Arner, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: VTT Technical Research Centre, Finland
name: Matej Oresic, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Aalborg Hospital, Denmark
name: Kim Overvad, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kuopio, Finland
name: Carsten Carlberg, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Nofima Foods, Norway
name: Grether I Borge, Senior Scientist
role: PRINCIPAL_INVESTIGATOR
References:
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.
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