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

Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Status: Invitation-only

Conditions: Metabolic Syndrome x; Cardiovascular Diseases; Mediterranean Diet

Treatments: Dietary Supplement: Mediterranean diet and exercise plan

Study type: Interventional

Funder types: Other

Identifiers

NCT03701425

083.2018

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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31 participants in 4 patient groups

Mediterranean diet and exercise plan

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Mediterranean diet and exercise plan

Mediterranean diet

Experimental group

Description:

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%

Treatment:

Dietary Supplement: Mediterranean diet and exercise plan

Only exercise

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Mediterranean diet and exercise plan

Low standard low fat diet

Active Comparator group

Description:

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%

Treatment:

Dietary Supplement: Mediterranean diet and exercise plan