Prevention of non-alcoholic fatty liver disease (NAFLD) and cardiovascular disease (CVD) through lifestyle intervention (MAUCO+) is a clinical trial that aims to improve sarcopenia, aerobic capacity, body composition, and lipid profile, insulin resistance, cardiovascular risk, NAFLD, and maintain a healthier lifestyle. Through the implementation of physical activity and nutritional programs.
BACKGROUND. Gallstone disease (GSD), including gallstones and cholecystectomy, is a common digestive disease worldwide, and Chile has one of the highest reported rates of gallstone prevalence. GSD, in particular cholecystectomy, has been associated with nonalcoholic fatty liver disease (NAFLD). In previous studies, investigators confirmed the association of cholecystectomy with a higher risk of NAFLD only in men. Additionally, reasearchers found a higher cardiovascular event risk in 3 years for male gallstone carriers. Investigators aim to step forward toward translational research by evaluating the effectiveness of a risk-reduction strategy customized to our population. STUDY GOALS. To evaluate a metabolic risk reduction strategy based on: 1. A Physical exercise trial to increase muscle mass and strength, and 2. A nutritional intervention based on an anti-inflammatory diet, sleep hygiene, and prolonged fasting periods. METHODS. Intensive Lifestyle Intervention, Randomized Controlled Trial: 300 participants will be randomly allocated to control (n=150) or an experimental group (n=150). The control group will receive standard prevention recommendations, personalized advice, educational material regarding lifestyle and metabolic diseases, and follow-up evaluation of physical activity, physical condition, anthropometry, diet, and sleep habits. The intervention group will receive, tailored to each participant: 3.1 An Exercise Program consisting of directly supervised and home-based telehealth sessions emphasizing muscle building, and 3.2. A Nutritional plus Program based on a diet rich in anti-inflammatory components and legumes, low in fat and refined carbohydrates, controlled energy according to BMI, extended nocturnal fasting periods, and healthy sleep habits. The programs will have a 6-month intensive phase of bi-weekly directly supervised exercise sessions in a municipality gym and a weekly telehealth session, followed by six months of telephone support and bi-monthly direct supervision to reinforce adherence and early identification of risk factors for abandonment. Intervention outcomes measured at baseline and years 1 and 2 are changes in non-invasive serum and ultrasound-based biomarkers of NAFLD; improvement in sarcopenia, aerobic capacity, body composition, lipid profile, insulin resistance, and cardiovascular risk; among overweight participants, permanent loss of at least 5% body weight; the decrease of depression symptoms, improvement of quality of life scores, and maintenance of a healthier lifestyle. EXPECTED RESULTS: is expected that a 12-month intervention of a personalized physical activity program together with a metabolic protective diet will improve markers of metabolic syndrome and NAFLD and decrease CVD risk scores in all participants who adhere to more than 50% of both interventions, with a clear dose-response effect.
Investigators will assess the efficiency of the intervention by measuring adherence to physical exercise and nutritional diet.
Centro MAUCO+
Molina, Maule Region, Chile
RECRUITINGPresence and severity of Non-Alcoholic Fatty liver Disease (NAFLD) at baseline and 12 month later.
It will be measured through the liver steatosis marker "Controlled Attenuation Parameter (CAP)" (dB/m).
Time frame: 36 months
Framingham Cardiovascular risk score
It will be measured at baseline and 12 months.
Time frame: 36 months
HDL cholesterol (mg/dL)
It will be measured at baseline and 12 months.
Time frame: 36 months
Triglycerides (mg/dL)
It will be measured at baseline and 12 months.
Time frame: 36 months
Glycemia (mg/dL)
It will be measured at baseline and 12 months.
Time frame: 36 months
Insulin (uU/mL)
It will be measured at baseline and 12 months.
Time frame: 36 months
HBA1c
It will be measured at baseline and 12 months.
Time frame: 36 months
usPCR (mg/L)
It will be measured at baseline and 12 months.
Time frame: 36 months
AST:ALT ratio
It will be measured at baseline and 12 months.
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
300
Time frame: 36 months
Total cholesterol (mg/dL)
It will be measured at baseline and 12 months.
Time frame: 36 months
Platelets (#cells/uL)
It will be measured at baseline and 12 months.
Time frame: 36 months
HOMA-IR
It will be measured at baseline and 12 months.
Time frame: 36 months
Total Bilirrubin (mg/dL)
It will be measured at baseline and 12 months.
Time frame: 36 months
Alkaline phosphatase (UI/l)
It will be measured at baseline and 12 months.
Time frame: 36 months
Glutamiz oxaloacetic transaminase (GOT) (UI/l)
It will be measured at baseline and 12 months.
Time frame: 36 months
Glutamic pyruvic trasaminase (GPT) (UI/l)
It will be measured at baseline and 12 months.
Time frame: 36 months
Gamma-glutamyl Transferase (GGT) (UI/l)
It will be measured at baseline and 12 months.
Time frame: 36 months
Metabolic syndrome
To be diagnosed with metabolic syndrome it is necessary to meet 3 or more conditions. (abdominal obesity, high triglycerides, low HDL cholesterol, high blood pressure and high fasting glucose). Metabolic syndrome will be measure at baseline and 12 month.
Time frame: 36 months