Prevention of NAFLD and CVD Through Lifestyle Intervention
- Conditions
- Gallstone DiseaseNon-Alcoholic Fatty Liver Disease
- Interventions
- Other: Physical exercise and dietary intervention for NAFLD
- Registration Number
- NCT05618626
- Lead Sponsor
- Pontificia Universidad Catolica de Chile
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- With and without gallstones disease
- With various degrees of NAFLD (none too severe)
- Any significant comorbidity or physical limitation to undergo resistance exercise program
- Use of medications that alter muscle mass (e.g., corticosteroids)
- History of hepatitis B or C
- Use of hepatotoxic drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Physical exercise and dietary intervention for NAFLD Physical exercise and dietary intervention for NAFLD The exercise program will consist of muscular strength and aerobic exercises; additionally, each session will start and end with low intensity warm-up and cool down periods. The program will be divided in months. Months 1-2, twice a week directly-supervised exercises group sessions, and 1 telehealth session. Months 3-6, once a week directly-supervised group session and twice a week home-based telehealth. Months 7-12, Monthly telephone support. Months 12, 24 and 36, All participants (control and intervention arms) will receive a full evaluation. In the dietary intervention, investigators proposed a diet rich in anti-inflammatory components, legumes and in dietary fiber. The baseline evaluation of nutritional condition includes: anthropometry, bioimpedance analysis, hepatobiliary ultrasound, Fibroscan,blood lipids, and a battery of metabolic markers and a diet survey, Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24). Both interventions are performed in parallel.
- Primary Outcome Measures
Name Time Method Presence and severity of Non-Alcoholic Fatty liver Disease (NAFLD) at baseline and 12 month later. 36 months It will be measured through the liver steatosis marker "Controlled Attenuation Parameter (CAP)" (dB/m).
- Secondary Outcome Measures
Name Time Method Glutamic pyruvic trasaminase (GPT) (UI/l) 36 months It will be measured at baseline and 12 months.
HOMA-IR 36 months It will be measured at baseline and 12 months.
Glutamiz oxaloacetic transaminase (GOT) (UI/l) 36 months It will be measured at baseline and 12 months.
Framingham Cardiovascular risk score 36 months It will be measured at baseline and 12 months.
HDL cholesterol (mg/dL) 36 months It will be measured at baseline and 12 months.
Triglycerides (mg/dL) 36 months It will be measured at baseline and 12 months.
Glycemia (mg/dL) 36 months It will be measured at baseline and 12 months.
Insulin (uU/mL) 36 months It will be measured at baseline and 12 months.
HBA1c 36 months It will be measured at baseline and 12 months.
usPCR (mg/L) 36 months It will be measured at baseline and 12 months.
AST:ALT ratio 36 months It will be measured at baseline and 12 months.
Total cholesterol (mg/dL) 36 months It will be measured at baseline and 12 months.
Platelets (#cells/uL) 36 months It will be measured at baseline and 12 months.
Total Bilirrubin (mg/dL) 36 months It will be measured at baseline and 12 months.
Alkaline phosphatase (UI/l) 36 months It will be measured at baseline and 12 months.
Gamma-glutamyl Transferase (GGT) (UI/l) 36 months It will be measured at baseline and 12 months.
Metabolic syndrome 36 months 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.
Trial Locations
- Locations (1)
Centro MAUCO+
🇨🇱Molina, Region Del Maule, Chile