Impact of Interventions With a Diet and Exercise on the Cardio-metabolic Status in Multi-risk Population (PANDEMONIO)
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.
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Mexico City, Meksyk, 03100
- National Medical Center "20 de Noviembre", ISSSTE
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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.
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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% |
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Eksperymentalny: 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%
|
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% |
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Aktywny komparator: 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.
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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% |
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Aktywny komparator: 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%
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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% |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Measure the profiles of body composition in the different groups.
Ramy czasowe: 3 months
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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
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3 months
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Measure the profiles of pro inflammatory biomarkers.
Ramy czasowe: 3 months
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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.
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3 months
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Compare the profiles of body composition and proinflammatory biomarkers after the follow-up between the different groups in patients with metabolic syndrome.
Ramy czasowe: 3 months
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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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3 months
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Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Oczekiwany)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 083.2018
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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