Interdisciplinary Project on Liver Health With a Focus on Steatotic Changes - Pilot Project of the Radiologic Technology, Dietetics, and Biomedical Analysis Programs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 主要终点
- Change From Baseline in Ultrasound-Guided Attenuation Parameter (UGAP)
研究概览
简要总结
This prospective randomized dietary intervention study investigates the effects of two dietary approaches on liver health in young adults over a 12-week period. Participants will be randomly assigned to either a Mediterranean diet intervention or a healthy diet based on general dietary recommendations.
Liver health will be assessed using the Ultrasound-Guided Attenuation Parameter (UGAP), together with laboratory parameters, body composition measurements, and anthropometric assessments. Measurements will be performed at baseline, after 6 weeks, and after 12 weeks.
The study aims to evaluate changes in liver fat and related metabolic parameters over time and to investigate associations between UGAP measurements, laboratory parameters, and body composition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 20 to 30 years
- •Currently enrolled as a student
- •Body mass index (BMI) less than or equal to 29 kg/m^2
- •Willingness to attend all three study visits at baseline, Week 6, and Week 12
- •Willingness to follow the assigned dietary intervention throughout the 12-week study period
- •Ability to understand the study information and provide written informed consent
排除标准
- •Known acute or chronic liver disease, including non-alcoholic fatty liver disease (NAFLD) or metabolic dysfunction-associated steatotic liver disease (MASLD)
- •Acute hepatitis
- •History of liver transplantation
- •Excessive alcohol consumption
- •Heart failure or ascites
- •Electronic or implanted medical devices that contraindicate bioelectrical impedance analysis (BIA), such as a cardiac pacemaker
- •Pregnancy
- •Regular use of medications other than oral contraceptives, including medications with potential hepatotoxic effects
- •Extreme dietary patterns or use of dietary supplements that may interfere with study outcomes
- •Unwillingness to follow the assigned dietary intervention or comply with standardized measurement conditions
- •Inability to provide informed consent
研究组 & 干预措施
Mediterranean Diet Intervention
Participants assigned to the Mediterranean diet intervention group receive standardized dietary education and are instructed to follow a Mediterranean dietary pattern for 12 weeks. Dietary guidance is delivered through standardized educational materials. Dietary intake and adherence are monitored using repeated 24-hour dietary recalls and food-frequency questionnaires (FFQs).
干预措施: Mediterranean Diet Intervention (Behavioral)
Control Group - General Dietary Recommendations
Participants assigned to the control group receive standardized dietary education based on general healthy eating recommendations for 12 weeks. Participants are encouraged to maintain their usual dietary habits while incorporating general healthy dietary recommendations, including the preferential use of plant-based oils instead of animal fats. The intervention does not specifically promote a Mediterranean dietary pattern.
干预措施: General Healthy Diet Intervention (Behavioral)
结局指标
主要结局
Change From Baseline in Ultrasound-Guided Attenuation Parameter (UGAP)
时间窗: Baseline, Week 6, and Week 12
Liver steatosis will be quantitatively assessed using the Ultrasound-Guided Attenuation Parameter (UGAP). Change from baseline will be assessed at Week 6 and Week 12.
次要结局
- Change in Visual Liver Steatosis Grade(Baseline, Week 6, and Week 12)
- Change From Baseline in Urinary Albumin Concentration(Baseline, Week 6, and Week 12)
- Change From Baseline in Aspartate Aminotransferase (AST)(Baseline, Week 6, and Week 12)
- Change From Baseline in Alanine Aminotransferase (ALT)(Baseline, Week 6, and Week 12)
- Change From Baseline in Urinary Creatinine Concentration(Baseline, Week 6, and Week 12)
- Change From Baseline in Gamma-Glutamyl Transferase (GGT)(Baseline, Week 6, and Week 12)
- Change From Baseline in Alkaline Phosphatase (ALP)(Baseline, Week 6, and Week 12)
- Change From Baseline in Bilirubin(Baseline, Week 6, and Week 12)
- Change From Baseline in Triglycerides(Baseline, Week 6, and Week 12)
- Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)(Baseline, Week 6, and Week 12)
- Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)(Baseline, Week 6, and Week 12)
- Change From Baseline in C-Reactive Protein (CRP)(Baseline, Week 6, and Week 12)
- Change From Baseline in Glycated Hemoglobin (HbA1c)(Baseline, Week 6, and Week 12)
- Change From Baseline in Body Fat Mass Assessed by Bioelectrical Impedance Analysis (BIA)(Baseline, Week 6, and Week 12)
- Change From Baseline in Skeletal Muscle Mass Assessed by Bioelectrical Impedance Analysis (BIA)(Baseline, Week 6, and Week 12)
- Change From Baseline in Total Body Water Assessed by Bioelectrical Impedance Analysis (BIA)(Baseline, Week 6, and Week 12)