Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Effect of Nordic Diet Rich in Whole Grain, Berries, Fruits, Vegetables and Fish on Features of Metabolic Syndrome - a Systems Biology Approach
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.


Options:
A: Arm Label: BALANCE group; Type: EXPERIMENTAL; Interventions: Behavioral: BALANCE | Arm Label: Control Diet group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Control diet | Intervention Type: BEHAVIORAL; Name: BALANCE; Assigned to Arm(s): BALANCE group | Intervention Type: BEHAVIORAL; Name: Control diet; Assigned to Arm(s): Control Diet group
B: Intervention Type: DRUG; Name: hormone replacement therapy; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: estrogens; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: progestins; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: estrogen replacement therapy; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: diet, fat-restricted; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: calcium; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: vitamin D; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: dietary supplements; Assigned to Arm(s): N/A
C: Arm Label: New Nordic Diet; Type: EXPERIMENTAL; Interventions: Behavioral: Dietary intervention | Arm Label: Average Danish Diet; Type: EXPERIMENTAL; Interventions: Behavioral: Dietary intervention | Intervention Type: BEHAVIORAL; Name: Dietary intervention; Assigned to Arm(s): Average Danish Diet, New Nordic Diet
D: Arm Label: Experimental diet; Type: EXPERIMENTAL; Interventions: Other: Experimental diet | Arm Label: Control diet; Type: ACTIVE_COMPARATOR; Interventions: Other: Control diet | Intervention Type: OTHER; Name: Experimental diet; Assigned to Arm(s): Experimental diet | Intervention Type: OTHER; Name: Control diet; Assigned to Arm(s): Control diet

Answer: D