Clinical Research Directory

Rehabilitation With Exercise-Based Intervention for Nonalcoholic Chronic Hepatic Esteatosis

This study proposes a single-blind randomized clinical trial designed to evaluate the effects of high-intensity interval training (HIIT) on liver health in adults with overweight or obesity, while also assessing the usefulness of FibroScan as a tool for detecting and monitoring hepatic changes. The study is grounded in the idea that HIIT may improve liver status in individuals with metabolic dysfunction-associated steatotic liver disease, even in the absence of major weight loss, and that FibroScan could serve not only as a diagnostic method but also as a follow-up instrument during conservative treatment. The sample will include 30 adults from the Los Ríos Region, aged 18 to 59 years, with BMI \>25 kg/m² and chronic noncommunicable conditions such as dyslipidemia, diabetes, or hypertension, provided they are fit for exercise. Participants will be randomly assigned to either an intervention group (HIIT, n=15) or a non-trained control group (n=15). Recruitment will be community-based, using posters and social media, and eligibility will be screened with the PAR-Q+ questionnaire. Individuals with excessive alcohol intake, liver disease of other etiologies, pregnancy, or contraindications to exercise will be excluded. The HIIT intervention will last 8 weeks, with 2 to 3 sessions per week, each session lasting 30 minutes. The protocol consists of five 2.5-minute bouts at 80% of heart rate reserve, interspersed with 2.5-minute active recovery periods at 20% of heart rate reserve. The training will be supervised by a physical therapist experienced in cardiometabolic exercise prescription, and the control group will receive training after the study is completed for ethical reasons. Before and after the intervention, participants will undergo a comprehensive evaluation including blood sampling, anthropometry, body composition, and physical fitness assessment. Blood markers will include transaminases, lipid profile, glucose, and HbA1c. Liver health will be assessed by FibroScan through controlled attenuation parameter (CAP) for steatosis and liver stiffness for fibrosis. Additional variables such as waist circumference, muscle mass, fat mass, handgrip strength, and prior physical activity level will also be recorded. Statistically, the study will compare baseline differences between groups and evaluate pre-post changes after the intervention using parametric or nonparametric tests according to data distribution, along with correlation and multiple regression analyses. The expected outcome is that HIIT will improve liver-related parameters, and that FibroScan will be sensitive enough to detect these changes, supporting its value as a regional clinical tool for the identification and follow-up of hepatic steatosis and fibrosis in people with overweight or obesity.

Time-restricted Feeding in MASLD

The recommended treatment for metabolic dysfunction-associated steatotic liver disease (MASLD) currently focuses on lifestyle changes, including dietary adjustments and increased physical activity. Intermittent fasting is a specific dietary approach in which food intake is restricted for certain periods. Recent scientific evidence suggests that intermittent fasting can positively influence body weight, insulin resistance, and markers of inflammation. This study will examine whether restricting energy intake to approximately 600 kcal on two days per week has beneficial effects on MASLD. The nutritional framework is based on the guidelines of the German Nutrition Society (DGE) for a healthy diet (10 rules for healthy eating). Following a two-week introduction to these DGE recommendations, participants will be randomly assigned to one of two treatment groups. In the intervention group, participants follow a 5:2 intermittent fasting regimen, eating without restrictions on five days per week and limiting intake to about one-quarter of their usual daily energy (≈600 kcal) on two non-consecutive days. In the control group, participants follow a healthy diet according to DGE guidelines without restrictions on timing or energy intake.