Cardiovascular Diseases and Nonalcoholic Fatty Liver Diseases Among Gallstone Patients and the Impact of a Novel Diet and Muscle Training Program

What this Trial Is About

Researchers are evaluating a lifestyle intervention to prevent non-alcoholic fatty liver disease (NAFLD) and cardiovascular disease (CVD) among adults aged 45 to 60, including those with gallstone disease. The study aims to improve muscle mass, aerobic capacity, body composition, lipid profiles, insulin resistance, cardiovascular risk, and maintain healthier habits through personalized exercise and dietary programs. This trial builds on findings linking gallstones and cholecystectomy to higher NAFLD and cardiovascular risks, especially in men. Participants are randomly assigned to one of two groups: the control group receives standard health advice and educational materials about lifestyle and metabolic diseases, while the intervention group follows a tailored program. The intervention combines a physical exercise plan with supervised and telehealth sessions focusing on muscle strength and aerobic fitness, alongside a nutritional program emphasizing an anti-inflammatory, legume-rich diet, controlled energy intake, prolonged fasting, and sleep hygiene. The intensive phase lasts six months with frequent supervised sessions, followed by six months of telephone support and less frequent supervision to encourage adherence. Participants undergo evaluations at the start, and at 12, 24, and 36 months, including physical assessments, blood tests, liver imaging, and questionnaires about diet, sleep, depression symptoms, and quality of life. Researchers will track changes in NAFLD severity, cardiovascular risk, metabolic markers, body weight, and lifestyle maintenance. The study extends over three years to monitor long-term effects and adherence to the programs.

Prevention of NAFLD and CVD Through Lifestyle Intervention