Reduction of the Metabolic Syndrome in Navarra-Spain
Condition: Metabolic Syndrome; Obesity; Diabetes; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a dietary pattern based on crononutrition
      and dietary training, together with dietary and psychological control, can reduce the body
      weight, improve the oxidative and inflammatory state in subjects with diagnosed metabolic
      syndrome features and can reduce the prevalence of the Metabolic syndrome in the population.
    

Detailed description: 
      The dietary pattern that characterizes the present nutritional intervention study is based on
      personalized diet, by elaborating tailoring-diets for each subject regarding his energetic
      needs and assuring a high adherence to the Mediterranean Diet. Moreover, the diet to be
      performed will be a hyperproteic diet to guarantee a satiety effect and a lower recovery of
      the lost weight, in accordance with the results derived from the main European study about
      nutrition (DIOGENES). The glycemic index/load will be also controlled in the study diet. The
      increase of the antioxidant capacity of the diet will be increased by the intake of fruits,
      walnuts and virgin olive oil among other antioxidant containing foods.

      The present initiative, based on the traditional diet, aims to integrate the main results
      obtained from diverse observational epidemiological studies and interventional studies in the
      dietary pattern of the present study. At the same time, the study will apply the concept of
      crononutrition by selecting and distributing the foods thorough the day according the
      physiological needs of each individual.

      In addition to the quantitative and qualitative composition of the diet, the study will take
      into account other important factors such as the behavior habits regarding the food, the
      frequency of consumption, the size of the eating portions, the distribution of the portions
      along the day, the feeling of fullness, the eating speed and so on. The aforementioned
      factors have recently been shown to be related to the gain of weight.

      Other non dietary factors, such as smoking habits, sedentary life, socio-economic level, will
      be also controlled in the present study. Moreover, the project will integrate the dietary
      support together with psychological support due to the fact that the state of mind has been
      shown to be associated with the MS in some scientific publications.
    

Intervention name(s): Crononutrition; American Heart Association
Intervention type(s): Behavioral; Behavioral
Intervention description(s): After the recruitment and selection of the study participants, the study will consists of a 2-month nutritional intervention (Crononutrition versus AHA) followed by second 6-month period ("autonomy phase") in which the subjects of the study will continue with their ruled dietary patterns, but without any dietary or psychological support.; After the recruitment and selection of the study participants, the study will consists of a 2-month nutritional intervention (Crononutrition versus AHA) followed by second 6-month period ("autonomy phase") in which the subjects of the study will continue with their ruled dietary patterns, but without any dietary or psychological support.
Other intervention name(s): RYTHMONUTRITION; METABOLIC SYNDROME; OBESITY; DIABETES; CARDIOVASCULAR DISEASE; RESMENA-S; RESMENA-A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metabolic syndrome; Oxidative stress; Proinflammatory state; Insulin resistance; Hypertension; Dyslipidemia; Mediterranean diet; Glycemic index; Hypocaloric diet; Hyperproteic diet; Macronutrient distribution; Antioxidant capacity of the diet; Crononutrition; Dietary and psychological support; Waist circumference