NCT05618626

Prevention of NAFLD and CVD Through Lifestyle Intervention

Cardiovascular Diseases (CVD) and Nonalcoholic Fatty Liver Diseases (NAFLD) Among Gallstone and Cholecystectomy Patients and the Impact of a Novel Diet and Muscle Training Program

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Pontificia Universidad Catolica de Chile · Academic / Other
• Sex: All
• Age: 45 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Non-Alcoholic Fatty Liver Disease
• Gallstone Disease

Interventions

Type	Name	Description
OTHER	Physical exercise and dietary intervention for NAFLD	Investigators will assess the efficiency of the intervention by measuring adherence to physical exercise and nutritional diet.

Timeline

• Start date: 2021-09-27
• Primary completion: 2025-04-28
• Completion: 2025-04-30
• First posted: 2022-11-16
• Last updated: 2024-11-19

Locations

1 site across 1 country: Chile