An interventional study of Mediterranean Diet Intervention and General Healthy Diet Intervention in Liver Health, sponsored by Hochschule Campus Wien (University of Applied Sciences Campus Vienna). Recruiting at 1 site in Austria. Open to participants aged 20 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Hochschule Campus Wien (University of Applied Sciences Campus Vienna) · Not applicable, Interventional, and Prevention
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.
662 studies on the registry are indexed under Fatty Liver; 184 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 431 interventional studies indexed under Fatty Liver.
Browse Fatty Liver studies →Hochschule Campus Wien (University of Applied Sciences Campus Vienna) is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 6, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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 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.
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.
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.
Time frame: Baseline, Week 6, and Week 12
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 6, and Week 12
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 6, and Week 12
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Dec 2026, 4 months after the start.
Of 136 non-industry interventional studies with no phase under Fatty Liver, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 4 months is below that.
Counting every sponsor, half of 145 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 6, 2026: primary completion Nov 2026 → Dec 2026 and completion Nov 2026 → Dec 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hochschule Campus Wien (University of Applied Sciences Campus Vienna)