Liver Health
Conditions
Keywords
Liver health, Hepatic steatosis, Ultrasound-Guided Attenuation Parameter (UGAP), Mediterranean diet, Dietary intervention, Body composition, Oxidative stress, DNA damage, Liver function tests
Brief summary
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.
Interventions
BEHAVIORALMediterranean Diet Intervention
Participants receive standardized dietary education and are instructed to follow a Mediterranean dietary pattern for 12 weeks. Core recommendations include approximately 4 tablespoons of olive oil per day, fish 2-3 times per week, legumes at least 3 times per week, and nuts or seeds at least 3 times per week. Participants are additionally encouraged to consume vegetables, fruits, whole-grain foods, and other foods characteristic of a Mediterranean dietary pattern, while limiting foods that are not characteristic of this dietary pattern.
BEHAVIORALGeneral Healthy Diet Intervention
Participants 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.
Sponsors
Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Ultrasound-Guided Attenuation Parameter (UGAP) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Liver Steatosis Grade | Baseline, Week 6, and Week 12 | Liver steatosis will be visually assessed and classified into steatosis grades 0-3. Changes in steatosis grade will be assessed over the 12-week intervention period. |
| Change From Baseline in Urinary Albumin Concentration | Baseline, Week 6, and Week 12 | Urinary albumin concentration will be assessed in spontaneous urine samples. Change from baseline will be assessed at Week 6 and Week 12. |
| Change From Baseline in Aspartate Aminotransferase (AST) | Baseline, Week 6, and Week 12 | Aspartate aminotransferase (AST) will be assessed in blood samples. Change from baseline will be assessed at Week 6 and Week 12. |
| Change From Baseline in Alanine Aminotransferase (ALT) | Baseline, Week 6, and Week 12 | Alanine aminotransferase (ALT) will be assessed in blood samples. Change from baseline will be assessed at Week 6 and Week 12. |
| Change From Baseline in Urinary Creatinine Concentration | Baseline, Week 6, and Week 12 | Urinary creatinine concentration will be assessed in spontaneous urine samples. Change from baseline will be assessed at Week 6 and Week 12. |
| Change From Baseline in Gamma-Glutamyl Transferase (GGT) | Baseline, Week 6, and Week 12 | Gamma-glutamyl transferase (GGT) will be assessed in blood samples. Change from baseline will be assessed at Week 6 and Week 12. |
| Change From Baseline in Alkaline Phosphatase (ALP) | Baseline, Week 6, and Week 12 | Alkaline phosphatase (ALP) will be assessed in blood samples. Change from baseline will be assessed at Week 6 and Week 12. |
| Change From Baseline in Bilirubin | Baseline, Week 6, and Week 12 | Bilirubin will be assessed in blood samples. Change from baseline will be assessed at Week 6 and Week 12. |
| Change From Baseline in Triglycerides | Baseline, Week 6, and Week 12 | Triglycerides will be assessed in blood samples. Change from baseline will be assessed at Week 6 and Week 12. |
| Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Baseline, Week 6, and Week 12 | High-density lipoprotein cholesterol (HDL-C) will be assessed in blood samples. Change from baseline will be assessed at Week 6 and Week 12. |
| Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) | Baseline, Week 6, and Week 12 | Low-density lipoprotein cholesterol (LDL-C) will be assessed in blood samples. Change from baseline will be assessed at Week 6 and Week 12. |
| Change From Baseline in C-Reactive Protein (CRP) | Baseline, Week 6, and Week 12 | C-reactive protein (CRP) will be assessed in blood samples. Change from baseline will be assessed at Week 6 and Week 12. |
| Change From Baseline in Glycated Hemoglobin (HbA1c) | Baseline, Week 6, and Week 12 | Glycated hemoglobin (HbA1c) will be assessed in blood samples. Change from baseline will be assessed at Week 6 and Week 12. |
| Change From Baseline in Body Fat Mass Assessed by Bioelectrical Impedance Analysis (BIA) | Baseline, Week 6, and Week 12 | Body fat mass will be assessed using bioelectrical impedance analysis (BIA). Change from baseline will be assessed at Week 6 and Week 12. |
| Change From Baseline in Skeletal Muscle Mass Assessed by Bioelectrical Impedance Analysis (BIA) | Baseline, Week 6, and Week 12 | Skeletal muscle mass will be assessed using bioelectrical impedance analysis (BIA). Change from baseline will be assessed at Week 6 and Week 12. |
| Change From Baseline in Total Body Water Assessed by Bioelectrical Impedance Analysis (BIA) | Baseline, Week 6, and Week 12 | Total body water will be assessed using bioelectrical impedance analysis (BIA). Change from baseline will be assessed at Week 6 and Week 12. |
Countries
Austria
Contacts
CONTACTDaniel Trimmel, MSc
CONTACTAgnes Draxler, PhD
PRINCIPAL_INVESTIGATORAgnes Draxler, PhD
Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
PRINCIPAL_INVESTIGATORDaniel Trimmel, MSc
Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
Outcome results
None listed