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

Primary Purpose

Cardiovascular Diseases, Metabolic Syndrome x, Mediterranean Diet

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Mediterranean diet and exercise plan
Sponsored by
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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

Sites / Locations

  • National Medical Center "20 de Noviembre", ISSSTE

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Mediterranean diet and exercise plan

Mediterranean diet

Only exercise

Low standard low fat diet

Arm 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.

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%

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.

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%

Outcomes

Primary Outcome Measures

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
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.
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

Secondary Outcome Measures

Full Information

First Posted
July 12, 2018
Last Updated
October 8, 2018
Sponsor
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
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1. Study Identification

Unique Protocol Identification Number
NCT03701425
Brief Title
Impact of Interventions With a Diet and Exercise on the Cardio-metabolic Status in Multi-risk Population
Acronym
PANDEMONIO
Official Title
Impact of Interventions With a Diet and Exercise on the Cardio-metabolic Status in Multi-risk Population
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
December 12, 2020 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Metabolic Syndrome x, Mediterranean Diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
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.
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mediterranean diet and exercise plan
Arm Type
Experimental
Arm 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.
Arm Title
Mediterranean diet
Arm Type
Experimental
Arm 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%
Arm Title
Only exercise
Arm Type
Active Comparator
Arm 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.
Arm Title
Low standard low fat diet
Arm Type
Active Comparator
Arm 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%
Intervention Type
Dietary Supplement
Intervention Name(s)
Mediterranean diet and exercise plan
Intervention Description
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%
Primary Outcome Measure Information:
Title
Measure the profiles of body composition in the different groups.
Description
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
Time Frame
3 months
Title
Measure the profiles of pro inflammatory biomarkers.
Description
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.
Time Frame
3 months
Title
Compare the profiles of body composition and proinflammatory biomarkers after the follow-up between the different groups in patients with metabolic syndrome.
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
National Medical Center "20 de Noviembre", ISSSTE
City
Mexico City
ZIP/Postal Code
03100
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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