Reduction of the Metabolic Syndrome in Navarra-Spain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Reduction of the Metabolic Syndrome in Navarra-Spain (RESMENA-S) Through an Innovative Multidisciplinary Strategy Based on the Crononutrition and Dietary Training Concepts, in Addition to Both Dietary and Psychological Control

Conditions
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Metabolic Syndrome, Obesity, Diabetes, Cardiovascular Disease

Intervention / Treatment
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* Behavioral: Crononutrition
* Behavioral: American Heart Association


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 35-70 years old Both sexes: Male and Female Metabolic Syndrome according to the IDF(2005)criteria: Waist circumference cutoffs (male ≥94 cm or female ≥80 cm) plus any two of the following four factors: Fasting glucose ≥5.55 mmol/L or use of antidiabetic medication Systolic BP ≥130 mm Hg, diastolic BP ≥85 mm Hg, or use of antihypertensive medication Fasting triglycerides ≥1.7 mm/L; and HDL-C <1.0 mm/L in men and <1.3 mm/L in women or specific treatment for this lipid abnormality Exclusion Criteria: Recent follow-up of diets designed for weight loss Unstable weight in the past 3 months Alcoholic and drug dependence Hormonal treatment No stable pharmacological treatment Eating-disordered behaviors Severe physical or mental disability Pregnancy Terminal disease Institutionalization

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Crononutrition<br>Dietary pattern: Personalized diet Caloric restriction (-30% Total energy intake) High adherence to the Mediterranean Diet Macronutrient distribution (30% Protein, 40% Carbohydrates and 30% Fat) Low glycemic index/load Increased antioxidant capacity of the diet | Behavioral: Crononutrition<br>* 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.<br>* Other names: RESMENA-S;|
| Placebo Comparator: American Heart Association<br>Dietary pattern: Personalized diet Caloric diet (-30% Total energy intake) Macronutrients distribution according to the American Heart Association (AHA) guidelines | Behavioral: American Heart Association<br>* 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.<br>* Other names: RESMENA-A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body fat | Through this specific nutritional intervention program we will try to reduce the metabolic syndrome features such as waist circumference, body weight and adiposity. To evaluate the body composition, bioimpedance, DEXA and anthropometry methodology will be used at the beginning and after two months of intervention. | One year | 
| Lipid profile | To evaluate lipid improvements the following measurements will be taking into account: Free fatty acids Total cholesterol HDL-cholesterol LDL-cholesterol | One year | 
| Glucose Profile | To evaluate glucose improvements the following measurements will be taking into account: Glucose Insulin HOMA | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation state | As secondary outcome some inflammatory markers will be analyzed: CRP IL-6 TNF-alpha IL-18 PAI-1 Homocystein | One year | 
| Oxidative stress | As secondary outcome some oxidative stress markers will be analyzed: MDA LDL-OX Total antioxidant capacity (TAC) | One year | 
| Psychological tests | Beck Depression Inventory Stai Trait Anxiety Inventory Mood thermometer visual analogue scale Anxiety thermometer visual analogue scale NEO personality inventory-revised test | January 2010-November 2011 | 
| Peripheral neurotransmitters | Dopamine Dopac Serotonin 5-Hydroxyindoleacetic acid Noradrenaline | March-April 2013 | 
| Epigenetics | DNA methylation microRNAs expression | April 2012-July 2014 | 
| Fatty Liver biomarkers / Non invasive liver scoring system. | Measurements in fatty liver biomarkers: Serum transaminases (AST & ALT (U/L)), GGT (U/L) and CK18 (U/L) concentrations will be measured in a fasting state at the beginning, at 2 months and at the end of the intervention. - A specificif Fatty Liver Index was calculated at the begining, at 2 months and at the end of the intervention. | May 2016- January 2017 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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