Cardiovascular Diseases, Mediterranean Diet, Metabolic Syndrome x
Conditions
Brief summary
The diseases derived from Metabolic Syndrome caused 75% of the total deaths. It is more profitable to invest in prevention than in the treatment of most cardiovascular diseases. Several institutions consider prevention as one of the main priorities in public health. Patients with Metabolic Syndrome, undergoing Mediterranean diet and exercise program, will have lower fat mass, greater lean mass and muscle strength; in addition to the lower expression of proinflammatory biomarkers, compared to those subjected to standard diet and exercise. OBJECTIVE: To evaluate the changes in body composition and cardiovascular risk in the population with metabolic syndrome undergoing a Mediterranean diet program and / or controlled physical activity. Design: Experimental, longitudinal design, controlled clinical trial, randomized. Population with Metabolic Syndrome in which the effect of Mediterranean diet and / or controlled physical activity will be compared on anthropometric parameters, body composition, cardiometabolic risk and plasma biomarkers.
Interventions
DIETARY_SUPPLEMENTMediterranean diet and exercise plan
Mediterranean diet: Diet: according to the definition, with the following distribution of macro nutrients: Protein contribution 0.8-1.2 Carbon Hydrates 45-50% Lipids 30%
Sponsors
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Random assignment, through software, to 4 treatment groups: one, first consume the Mediterranean and exercise plan, second group will be given only nutritional plan with Mediterranean diet, the third group only exercise plan, and the fourth control group which will give a low standard low fat.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients with a diagnosis of metabolic syndrome. * Patients diagnosed with overweight. * Patients diagnosed with obesity. * Patients with a diagnosis of systemic arterial hypertension. * Patients diagnosed with type 2 diabetes mellitus. * Patients with dyslipidemia.
Exclusion criteria
* Recent myocardial infarction * Pregnancy * Lactation * In pharmacological treatment for weight loss. * Cancer. * Chronic kidney disease * Liver failure * Heart failure. * Chronic obstructive pulmonary disease * Depression * Malabsorption syndrome * Chronic diarrhea
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure the profiles of body composition in the different groups. | 3 months | Measure the basal profiles of body composition (weight in kilograms and height in meters, body mass index in kg/m\^2, bio impedance will be done by bioimpedance multifrequency, 8 points) in the different groups |
| Measure the profiles of pro inflammatory biomarkers. | 3 months | Determine the basal pro-inflammatory biomarkers (interleukins 1 beta in picograms per liter , interleukin 2 in picograms per liter , interleukins 10 in picograms per liter ) in the 4 different groups. |
| Compare the profiles of body composition and proinflammatory biomarkers after the follow-up between the different groups in patients with metabolic syndrome. | 3 months | To compare the profiles of body composition and proinflammatory biomarkers after a program of physical activity and feeding plan, in the different groups of patients with metabolic syndrome after the follow-up and classify by groups, responds or not responds for analysis |
Countries
Mexico
Outcome results
None listed