Gallstone Disease, Non-Alcoholic Fatty Liver Disease
Conditions
Keywords
Anti-inflammatory diet, Lifestyle modification, Physical Activity
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.
Interventions
OTHERPhysical exercise and dietary intervention for NAFLD
Investigators will assess the efficiency of the intervention by measuring adherence to physical exercise and nutritional diet.
Sponsors
Pontificia Universidad Catolica de Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* With and without gallstones disease * With various degrees of NAFLD (none too severe)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| usPCR (mg/L) | 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. |
| Glutamiz oxaloacetic transaminase (GOT) (UI/l) | 36 months | It will be measured at baseline and 12 months. |
| Glutamic pyruvic trasaminase (GPT) (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. |
| 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. |
| 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. |
| HOMA-IR | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index (BMI) (kg/m^2) | 36 months | A BMI will considered Underweight, Normal, Overweight or Obesity if it is less than 18.5 kg/m\^2, it is between 18.5 and 24.9 kg/m\^2, it is between 25 and 29.9 kg/m\^2, or it is equal or greater than 30 kg/m\^2, respectively. |
| Aerobic capacity VO2max (ml/kg/min) | 36 months | Aerobic capacity VO2max will be measure at baseline and 12 month |
| Waist circumference (cm) | 36 months | Waist circumference will be measure at baseline and 12 month. |
| Muscular mass percentage measure | 36 months | Muscular mass percentage will be measure by bioimpedance analysis at baseline and 12 month. |
| Body fat percentage | 36 months | Body fat percentage will be measure by bioimpedance analysis at baseline and 12 month. |
Countries
Chile
Contacts
Primary ContactLaura A Huidobro, PhD
Backup ContactCatterina Ferreccio, MD
Outcome results
None listed