Impact of Interventions With a Diet and Exercise on the Cardio-metabolic Status in Multi-risk Population

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Interventions With a Diet and Exercise on the Cardio-metabolic Status in Multi-risk Population

Conditions
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Cardiovascular Diseases, Metabolic Syndrome x, Mediterranean Diet

Intervention / Treatment
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* Dietary Supplement: Mediterranean diet and exercise plan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mediterranean diet and exercise plan<br>Random assignment, through software, to 4 groups of treatment: consume the Mediterranean diet: according to the definition, with the distribution of macronutrients: Protein contribution 0.8-1.2 gram, Carbon Hydrates 45-50% Lipids 30% An exercise plan: The classic exercise program who they will carry out a 5-minute warm-up program with active mobilizations. After that, they will perform intervals of 5 min with resistance to maintain the heart rate prescribed, with active breaks of 1 - 2 min, 4 repetitions. At the end, there will be a return to calm The program of high-intensity anaerobic exercise will consist of a 5-minute warm-up , followed by 5 sets of isokinetic exercise with protocol November 20, rest of 90 s between series. The program will be done 3 times per week for 12 weeks. | Dietary Supplement: Mediterranean diet and exercise plan<br>* 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%<br>|
| Experimental: Mediterranean diet<br>Random assignment, through software, to 4 groups of treatment: consume the Mediterranean diet: according to the definition, with the following distribution of macro nutrients: Protein contribution 0.8-1.2 gram Carbon Hydrates 45-50% Lipids 30% | Dietary Supplement: Mediterranean diet and exercise plan<br>* 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%<br>|
| Active Comparator: Only exercise<br>An exercise plan: The classic exercise program who they will carry out a 5-minute warm-up program with active mobilizations. After that, they will perform intervals of 5 min with resistance to maintain the heart rate prescribed, with active breaks of 1 - 2 min, 4 repetitions. At the end, there will be a return to calm The program of high-intensity anaerobic exercise will consist of a 5-minute warm-up , followed by 5 sets of isokinetic exercise with protocol November 20, rest of 90 s between series. The program will be done 3 times per week for 12 weeks. | Dietary Supplement: Mediterranean diet and exercise plan<br>* 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%<br>|
| Active Comparator: Low standard low fat diet<br>Random assignment, through software, to 4 groups of treatment: consume the low standard low fat diet: according to the definition, with the following distribution of macro nutrients:Protein contribution 0.8-1.2 Carbon Hydrates 45-50% Lipids 20% | Dietary Supplement: Mediterranean diet and exercise plan<br>* 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%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the profiles of body composition in the different groups. | 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 | 3 months | 
| Measure the profiles of pro inflammatory biomarkers. | 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. | 3 months | 
| Compare the profiles of body composition and proinflammatory biomarkers after the follow-up between the different groups in patients with metabolic syndrome. | 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 | 3 months |