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

NCT03701425 | Unknown DMC

• 1 other identifier: 083.2018
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

Mediterranean diet and exercise plan

EXPERIMENTAL

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

Mediterranean diet

EXPERIMENTAL

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

Only exercise

ACTIVE COMPARATOR

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

Low standard low fat diet

ACTIVE COMPARATOR

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

Interventions

Mediterranean diet and exercise plan 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; Mediterranean diet; Mediterranean diet and exercise plan; Only exercise

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado: lead

Study Sites (1)

National Medical Center "20 de Noviembre", ISSSTE

Mexico City, 03100, Mexico

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Metabolic Syndrome

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph D

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: October 10, 2018
• Study Start: June 1, 2017
• Primary Completion: December 12, 2020
• Study Completion: December 1, 2024
• Last Updated: October 10, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)