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

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ClinicalTrials.gov Identifier: NCT03701425
Recruitment Status : Enrolling by invitation
First Posted : October 10, 2018
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
Juan Antonio Suárez Cuenca, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

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.


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Metabolic Syndrome x Mediterranean Diet Dietary Supplement: Mediterranean diet and exercise plan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Primary Purpose: Treatment
Official Title: Impact of Interventions With a Diet and Exercise on the Cardio-metabolic Status in Multi-risk Population
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 12, 2020
Estimated Study Completion Date : December 1, 2024


Arm Intervention/treatment
Experimental: 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.
Dietary Supplement: 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%


Experimental: 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%
Dietary Supplement: 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%


Active Comparator: 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.
Dietary Supplement: 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%


Active Comparator: 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%
Dietary Supplement: 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%





Primary Outcome Measures :
  1. Measure the profiles of body composition in the different groups. [ Time Frame: 3 months ]
    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

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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03701425


Locations
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Mexico
National Medical Center "20 de Noviembre", ISSSTE
Mexico City, Mexico, 03100
Sponsors and Collaborators
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

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Responsible Party: Juan Antonio Suárez Cuenca, Ph D, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
ClinicalTrials.gov Identifier: NCT03701425     History of Changes
Other Study ID Numbers: 083.2018
First Posted: October 10, 2018    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metabolic Syndrome
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Nutrients
Growth Substances
Physiological Effects of Drugs