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NCT Number: NCT07786831

Dietary Intervention Study on Liver Health in Young Adults

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.

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Key information

Conditions

Liver Health Digestive System Diseases Fatty Liver Liver Diseases

Age range

20 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change From Baseline in Ultrasound-Guided Attenuation Parameter (UGAP)

    Time frame: 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 outcomes

  1. Change in Visual Liver Steatosis Grade

    Time frame: 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.

  2. Change From Baseline in Urinary Albumin Concentration

    Time frame: 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.

  3. Change From Baseline in Aspartate Aminotransferase (AST)

    Time frame: 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.

  4. Change From Baseline in Alanine Aminotransferase (ALT)

    Time frame: 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.

  5. Change From Baseline in Urinary Creatinine Concentration

    Time frame: 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.

  6. Change From Baseline in Gamma-Glutamyl Transferase (GGT)

    Time frame: 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.

  7. Change From Baseline in Alkaline Phosphatase (ALP)

    Time frame: 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.

  8. Change From Baseline in Bilirubin

    Time frame: 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.

  9. Change From Baseline in Triglycerides

    Time frame: 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.

  10. Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)

    Time frame: 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.

  11. Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)

    Time frame: 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.

  12. Change From Baseline in C-Reactive Protein (CRP)

    Time frame: 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.

  13. Change From Baseline in Glycated Hemoglobin (HbA1c)

    Time frame: 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.

  14. Change From Baseline in Body Fat Mass Assessed by Bioelectrical Impedance Analysis (BIA)

    Time frame: 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.

  15. Change From Baseline in Skeletal Muscle Mass Assessed by Bioelectrical Impedance Analysis (BIA)

    Time frame: 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.

  16. Change From Baseline in Total Body Water Assessed by Bioelectrical Impedance Analysis (BIA)

    Time frame: 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.

Other outcomes

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

    Time frame: Baseline, Week 6, and Week 12

    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.

  2. Change From Baseline in Malondialdehyde (MDA) Concentration

    Time frame: Baseline, Week 6, and Week 12

    Malondialdehyde (MDA) concentration will be assessed as a biomarker of oxidative stress. Change from baseline will be assessed at Week 6 and Week 12.

  3. Change From Baseline in Ferric Reducing Antioxidant Power (FRAP)

    Time frame: Baseline, Week 6, and Week 12

    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.

  4. Change From Baseline in Plasma Reduced Glutathione (GSH) Concentration

    Time frame: Baseline, Week 6, and Week 12

    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.

  5. Change From Baseline in Plasma Oxidized Glutathione (GSSG) Concentration

    Time frame: Baseline, Week 6, and Week 12

    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.

  6. Change From Baseline in Waist Circumference

    Time frame: Baseline, Week 6, and Week 12

    Waist circumference will be measured at each study visit. Change from baseline will be assessed at Week 6 and Week 12.

  7. Change From Baseline in Hip Circumference

    Time frame: Baseline, Week 6, and Week 12

    Hip circumference will be measured at each study visit. Change from baseline will be assessed at Week 6 and Week 12.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Trimmel, MSc

CONTACT

[email protected]

+43 1 606 68 77 ext. 4824

Sponsors and collaborators

Lead sponsor

Hochschule Campus Wien (University of Applied Sciences Campus Vienna)

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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