Reduction of the Metabolic Syndrome in Navarra-Spain

Clinica Universidad de Navarra, Universidad de Navarra109 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

109

Conditions

Metabolic Syndrome Obesity Diabetes Cardiovascular Disease

Interventions

CrononutritionBEHAVIORAL

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.

American Heart AssociationBEHAVIORAL

Eligibility

Sex: ALLMin age: 35 YearsMax age: 70 Years

Medical Language ↔ Plain English

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: 1. Fasting glucose ≥5.55 mmol/L or use of antidiabetic medication 2. Systolic BP ≥130 mm Hg, diastolic BP ≥85 mm Hg, or use of antihypertensive medication 3. 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

Locations (1)

University of Navarra

Pamplona, Navarre, Spain

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: One year

Glucose Profile

To evaluate glucose improvements the following measurements will be taking into account: * Glucose * Insulin * HOMA

Time frame: One year

Secondary Outcomes

Inflammation state

As secondary outcome some inflammatory markers will be analyzed: * CRP * IL-6 * TNF-alpha * IL-18 * PAI-1 * Homocystein

Time frame: One year

Oxidative stress

As secondary outcome some oxidative stress markers will be analyzed: * MDA * LDL-OX * Total antioxidant capacity (TAC)

Time frame: 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

Time frame: January 2010-November 2011

Peripheral neurotransmitters

* Dopamine * Dopac * Serotonin * 5-Hydroxyindoleacetic acid * Noradrenaline

Data from ClinicalTrials.gov

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