Dietary Intervention Study on Liver Health in Young Adults

Interdisciplinary Project on Liver Health With a Focus on Steatotic Changes - Pilot Project of the Radiologic Technology, Dietetics, and Biomedical Analysis Programs

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Health
• Intervention / Treatment: Behavioral: Mediterranean Diet Intervention; Behavioral: General Healthy Diet Intervention

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Trimmel, MSc; Phone Number: 4824 +43 1 606 68 77; Email: daniel.trimmel@hcw.ac.at
• Study Contact Backup: Name: Agnes Draxler, PhD; Phone Number: 4207 +43 1 606 68 77; Email: agnes.draxler@hcw.ac.at

Study Locations

• Austria
  • Austria
    • Vienna, Austria, Austria, 1100
      • Recruiting
      • Hochschule Campus Wien
      • Contact: Daniel Trimmel, MSc; Phone Number: 4824 +43 1 606 68 77; Email: daniel.trimmel@hcw.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Behavioral: Mediterranean 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.
Active Comparator: 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.	Behavioral: General 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Ultrasound-Guided Attenuation Parameter (UGAP)	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.	Baseline, Week 6, and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Liver Steatosis Grade	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.	Baseline, Week 6, and Week 12
Change From Baseline in Urinary Albumin Concentration	Urinary albumin concentration will be assessed in spontaneous urine samples. Change from baseline will be assessed at Week 6 and Week 12.	Baseline, Week 6, and Week 12
Change From Baseline in Aspartate Aminotransferase (AST)	Aspartate aminotransferase (AST) will be assessed in blood samples. Change from baseline will be assessed at Week 6 and Week 12.	Baseline, Week 6, and Week 12
Change From Baseline in Alanine Aminotransferase (ALT)	Alanine aminotransferase (ALT) will be assessed in blood samples. Change from baseline will be assessed at Week 6 and Week 12.	Baseline, Week 6, and Week 12
Change From Baseline in Urinary Creatinine Concentration	Urinary creatinine concentration will be assessed in spontaneous urine samples. Change from baseline will be assessed at Week 6 and Week 12.	Baseline, Week 6, and Week 12
Change From Baseline in Gamma-Glutamyl Transferase (GGT)	Gamma-glutamyl transferase (GGT) will be assessed in blood samples. Change from baseline will be assessed at Week 6 and Week 12.	Baseline, Week 6, and Week 12
Change From Baseline in Alkaline Phosphatase (ALP)	Alkaline phosphatase (ALP) will be assessed in blood samples. Change from baseline will be assessed at Week 6 and Week 12.	Baseline, Week 6, and Week 12
Change From Baseline in Bilirubin	Bilirubin will be assessed in blood samples. Change from baseline will be assessed at Week 6 and Week 12.	Baseline, Week 6, and Week 12
Change From Baseline in Triglycerides	Triglycerides will be assessed in blood samples. Change from baseline will be assessed at Week 6 and Week 12.	Baseline, Week 6, and Week 12
Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)	High-density lipoprotein cholesterol (HDL-C) will be assessed in blood samples. Change from baseline will be assessed at Week 6 and Week 12.	Baseline, Week 6, and Week 12
Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)	Low-density lipoprotein cholesterol (LDL-C) will be assessed in blood samples. Change from baseline will be assessed at Week 6 and Week 12.	Baseline, Week 6, and Week 12
Change From Baseline in C-Reactive Protein (CRP)	C-reactive protein (CRP) will be assessed in blood samples. Change from baseline will be assessed at Week 6 and Week 12.	Baseline, Week 6, and Week 12
Change From Baseline in Glycated Hemoglobin (HbA1c)	Glycated hemoglobin (HbA1c) will be assessed in blood samples. Change from baseline will be assessed at Week 6 and Week 12.	Baseline, Week 6, and Week 12
Change From Baseline in Body Fat Mass Assessed by Bioelectrical Impedance Analysis (BIA)	Body fat mass will be assessed using bioelectrical impedance analysis (BIA). Change from baseline will be assessed at Week 6 and Week 12.	Baseline, Week 6, and Week 12
Change From Baseline in Skeletal Muscle Mass Assessed by Bioelectrical Impedance Analysis (BIA)	Skeletal muscle mass will be assessed using bioelectrical impedance analysis (BIA). Change from baseline will be assessed at Week 6 and Week 12.	Baseline, Week 6, and Week 12
Change From Baseline in Total Body Water Assessed by Bioelectrical Impedance Analysis (BIA)	Total body water will be assessed using bioelectrical impedance analysis (BIA). Change from baseline will be assessed at Week 6 and Week 12.	Baseline, Week 6, and Week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in DNA Damage Measured as Percentage of DNA in the Comet Tail	DNA damage will be assessed using the comet assay and expressed as the percentage of DNA in the comet tail (% tail DNA). Change from baseline will be assessed at Week 6 and Week 12.	Baseline, Week 6, and Week 12
Change From Baseline in Malondialdehyde (MDA) Concentration	Malondialdehyde (MDA) concentration will be assessed as a biomarker of oxidative stress. Change from baseline will be assessed at Week 6 and Week 12.	Baseline, Week 6, and Week 12
Change From Baseline in Ferric Reducing Antioxidant Power (FRAP)	Ferric reducing antioxidant power (FRAP) will be assessed as a measure of antioxidant capacity. Change from baseline will be assessed at Week 6 and Week 12.	Baseline, Week 6, and Week 12
Change From Baseline in Plasma Reduced Glutathione (GSH) Concentration	Plasma reduced glutathione (GSH) concentration will be assessed as a marker of redox status. Change from baseline will be assessed at Week 6 and Week 12.	Baseline, Week 6, and Week 12
Change From Baseline in Plasma Oxidized Glutathione (GSSG) Concentration	Plasma oxidized glutathione (GSSG) concentration will be assessed as a marker of redox status. Change from baseline will be assessed at Week 6 and Week 12.	Baseline, Week 6, and Week 12
Change From Baseline in Waist Circumference	Waist circumference will be measured at each study visit. Change from baseline will be assessed at Week 6 and Week 12.	Baseline, Week 6, and Week 12
Change From Baseline in Hip Circumference	Hip circumference will be measured at each study visit. Change from baseline will be assessed at Week 6 and Week 12.	Baseline, Week 6, and Week 12

Collaborators and Investigators

• Sponsor: Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
• Investigators: Principal Investigator: Agnes Draxler, PhD, Hochschule Campus Wien (University of Applied Sciences Campus Vienna); Principal Investigator: Daniel Trimmel, MSc, Hochschule Campus Wien (University of Applied Sciences Campus Vienna)

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: August 19, 2026
• First Submitted That Met QC Criteria: August 25, 2026
• First Posted (Actual): August 26, 2026

Study Record Updates

• Last Update Posted (Actual): September 15, 2026
• Last Update Submitted That Met QC Criteria: September 14, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Oxidative stress; Body composition; DNA damage; Hepatic steatosis; Mediterranean diet; Liver function tests; Dietary intervention; Liver health; Ultrasound-Guided Attenuation Parameter (UGAP)
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver
• Other Study ID Numbers: HCW-LIVER-2026; 26000979 (Other Identifier: Ethics Committee of Hochschule Campus Wien)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No