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

NCT ID: NCT03701425

Last Updated: 2018-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2024-12-01

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.

Conditions

Cardiovascular Diseases; Metabolic Syndrome x; Mediterranean Diet

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mediterranean diet and exercise plan

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.

Group Type: EXPERIMENTAL

Mediterranean diet and exercise plan

Intervention Type: DIETARY_SUPPLEMENT

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%

Mediterranean diet

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%

Group Type: EXPERIMENTAL

Mediterranean diet and exercise plan

Intervention Type: DIETARY_SUPPLEMENT

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%

Only exercise

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.

Group Type: ACTIVE_COMPARATOR

Mediterranean diet and exercise plan

Intervention Type: DIETARY_SUPPLEMENT

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%

Low standard low fat diet

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%

Group Type: ACTIVE_COMPARATOR

Mediterranean diet and exercise plan

Intervention Type: DIETARY_SUPPLEMENT

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%

Interventions

Mediterranean 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%

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

OTHER_GOV

Sponsor Role: lead

Responsible Party

Juan Antonio Suárez Cuenca

Ph D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Medical Center "20 de Noviembre", ISSSTE

Mexico City, , Mexico

Countries

Mexico

Other Identifiers

083.2018

Identifier Type: -

Identifier Source: org_study_id