Status:
COMPLETED
The Effect of Nordic Recommended Diet on the Features of Metabolic Syndrome - Multicentre Study
Lead Sponsor:
Marjukka Kolehmainen
Collaborating Sponsors:
University of Copenhagen
Aarhus University Hospital
Conditions:
Abdominal Obesity
Insulin Resistance
Eligibility:
All Genders
30-65 years
Phase:
NA
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 Nor...
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 Rec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
167 Patients enrolled
Trial Details
Trial ID
NCT00992641
Start Date
August 1 2009
End Date
December 1 2011
Last Update
April 17 2012
Active Locations (8)
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1
Aarhus University
Aarhus, Denmark
2
University of Copenhagen
Copenhagen, Denmark
3
University of Kuopio
Kuopio, Finland, FIN-70211
4
University of Oulu
Oulu, Finland