Dietary Intervention Study on Liver Health in Young Adults

NCT07786831 | Recruiting

• 2 other identifiers: HCW-LIVER-202626000979
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Health

Keywords

Liver health; Hepatic steatosis; Ultrasound-Guided Attenuation Parameter (UGAP); Mediterranean diet; Dietary intervention; Body composition; Oxidative stress; DNA damage; Liver function tests

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• 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

Other Outcomes (7)

• Change From Baseline in DNA Damage Measured as Percentage of DNA in the Comet Tail

  Baseline, Week 6, and Week 12

• Change From Baseline in Malondialdehyde (MDA) Concentration

  Baseline, Week 6, and Week 12

• Change From Baseline in Ferric Reducing Antioxidant Power (FRAP)

  Baseline, Week 6, and Week 12

Study Arms (2)

Mediterranean Diet Intervention

EXPERIMENTAL

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

Control Group - General Dietary Recommendations

ACTIVE COMPARATOR

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

Interventions

Mediterranean Diet Intervention BEHAVIORAL

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.

Mediterranean Diet Intervention

General Healthy Diet Intervention BEHAVIORAL

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.

Control Group - General Dietary Recommendations

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hochschule Campus Wien (University of Applied Sciences Campus Vienna): lead

Study Sites (1)

Hochschule Campus Wien

Vienna, Austria, 1100, Austria

RECRUITING

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Trimmel, MSc

CONTACT

+43 1 606 68 77; daniel.trimmel@hcw.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 26, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)