Clinical trial NCT05618626: Prevention of NAFLD and CVD Through Lifestyle Intervention
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Gallstone Disease
Keywords: Anti-inflammatory diet
Lifestyle modification
Physical Activity
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 300
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence and severity of Non-Alcoholic Fatty liver Disease (NAFLD) at baseline and 12 month later.
timeFrame: 36 months
Secondary outcomes:
measure: Framingham Cardiovascular risk score
timeFrame: 36 months
measure: HDL cholesterol (mg/dL)
timeFrame: 36 months
measure: Triglycerides (mg/dL)
timeFrame: 36 months
measure: Glycemia (mg/dL)
timeFrame: 36 months
measure: Insulin (uU/mL)
timeFrame: 36 months
measure: HBA1c
timeFrame: 36 months
measure: usPCR (mg/L)
timeFrame: 36 months
measure: AST:ALT ratio
timeFrame: 36 months
measure: Total cholesterol (mg/dL)
timeFrame: 36 months
measure: Platelets (#cells/uL)
timeFrame: 36 months
measure: HOMA-IR
timeFrame: 36 months
measure: Total Bilirrubin (mg/dL)
timeFrame: 36 months
measure: Alkaline phosphatase (UI/l)
timeFrame: 36 months
measure: Glutamiz oxaloacetic transaminase (GOT) (UI/l)
timeFrame: 36 months
measure: Glutamic pyruvic trasaminase (GPT) (UI/l)
timeFrame: 36 months
measure: Gamma-glutamyl Transferase (GGT) (UI/l)
timeFrame: 36 months
measure: Metabolic syndrome
timeFrame: 36 months
Other outcomes:
measure: Muscular mass percentage measure
timeFrame: 36 months
measure: Body fat percentage
timeFrame: 36 months
measure: Body Mass Index (BMI) (kg/m^2)
timeFrame: 36 months
measure: Aerobic capacity VO2max (ml/kg/min)
timeFrame: 36 months
measure: Waist circumference (cm)
timeFrame: 36 months
Locations:
city: Molina
country: Chile
facility: Centro MAUCO+
state: Region Del Maule
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: Catterina Ferreccio, MD
role: PRINCIPAL_INVESTIGATOR
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