Liver HealthNCT07786831
Dietary Intervention Study on Liver Health in Young Adults
A study testing Mediterranean Diet Intervention and General Healthy Diet Intervention in people with Liver Health, run by Hochschule Campus Wien (University of Applied Sciences Campus Vienna) at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Health
- What is being tested?
- Mediterranean Diet Intervention and General Healthy Diet Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- 31 Aug 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 20 to 30 years
- Currently enrolled as a student
- Body mass index (BMI) ≤ 39.9 kg/m²
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Hochschule Campus Wien
Vienna, Austria, 1100
Daniel Trimmel, MSc, +43 1 606 68 77 ext. 4824, daniel.trimmel@hcw.ac.at
About this study
Official title: 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.
- Conditions
- Liver Health
- Being tested
- Mediterranean Diet Intervention, General Healthy Diet Intervention
- Keywords
- Liver health, Hepatic steatosis, Ultrasound-Guided Attenuation Parameter (UGAP), Mediterranean diet, Dietary intervention, Body composition, Oxidative stress, DNA damage, Liver function tests
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean Diet InterventionBehavioural
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 InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: General Healthy Diet Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 6, and Week 12
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 6, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start31 Aug 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agnes Draxler, PhD, Principal investigator, Hochschule Campus Wien (University of Applied Sciences Campus Vienna)Daniel Trimmel, MSc, Principal investigator, Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786831
- Sponsor's protocol ID
- HCW-LIVER-2026
- Other IDs
- 26000979
- Status last verified
- Nov 2026
- First submitted
- 19 Aug 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interdisciplinary Project on Liver Health With a Focus on Steatotic Changes - Pilot Project of the Radiologic Technology, Dietetics, and Biomedical Analysis Programs
- ClinicalTrials.gov ID
- NCT07786831
- Acronym / sponsor ID
- HCW-LIVER-2026
- Conditions
- Liver Health
- Keywords
- Liver health, Hepatic steatosis, Ultrasound-Guided Attenuation Parameter (UGAP), Mediterranean diet, Dietary intervention, Body composition, Oxidative stress, DNA damage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hochschule Campus Wien (University of Applied Sciences Campus Vienna)University, hospital or other
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet Intervention | Experimental | Behavioral: Mediterranean Diet InterventionParticipants 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). |
| Control Group - General Dietary Recommendations | Active comparator | Behavioral: General Healthy Diet InterventionParticipants 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. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 20 to 30 years
- Currently enrolled as a student
- Body mass index (BMI) ≤ 39.9 kg/m²
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean Diet InterventionParticipants 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. | Behavioural | Mediterranean Diet Intervention |
| General Healthy Diet InterventionParticipants 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. | Behavioural | Control Group - General Dietary Recommendations |
Primary outcome
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.
16 secondary outcomes
Change in Visual Liver Steatosis Grade
Time frame: Baseline, Week 6, and Week 12
Change From Baseline in Urinary Albumin Concentration
Time frame: Baseline, Week 6, and Week 12
Change From Baseline in Aspartate Aminotransferase (AST)
Time frame: Baseline, Week 6, and Week 12
Change From Baseline in Alanine Aminotransferase (ALT)
Time frame: Baseline, Week 6, and Week 12
Change From Baseline in Urinary Creatinine Concentration
Time frame: Baseline, Week 6, and Week 12
Change From Baseline in Gamma-Glutamyl Transferase (GGT)
Time frame: Baseline, Week 6, and Week 12
Change From Baseline in Alkaline Phosphatase (ALP)
Time frame: Baseline, Week 6, and Week 12
Change From Baseline in Bilirubin
Time frame: Baseline, Week 6, and Week 12
Change From Baseline in Triglycerides
Time frame: Baseline, Week 6, and Week 12
Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)
Time frame: Baseline, Week 6, and Week 12
Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline, Week 6, and Week 12
Change From Baseline in C-Reactive Protein (CRP)
Time frame: Baseline, Week 6, and Week 12
Change From Baseline in Glycated Hemoglobin (HbA1c)
Time frame: Baseline, Week 6, and Week 12
Change From Baseline in Body Fat Mass Assessed by Bioelectrical Impedance Analysis (BIA)
Time frame: Baseline, Week 6, and Week 12
Change From Baseline in Skeletal Muscle Mass Assessed by Bioelectrical Impedance Analysis (BIA)
Time frame: Baseline, Week 6, and Week 12
Change From Baseline in Total Body Water Assessed by Bioelectrical Impedance Analysis (BIA)
Time frame: Baseline, Week 6, and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Agnes Draxler, PhD principal investigator
Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
Daniel Trimmel, MSc principal investigator
Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean Diet Intervention and General Healthy Diet Intervention in people with Liver Health, run by Hochschule Campus Wien (University of Applied Sciences Campus Vienna) at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Trimmel, MSc (+43 1 606 68 77 ext. 4824, daniel.trimmel@hcw.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Ultrasound-Guided Attenuation Parameter (UGAP) (time frame: Baseline, Week 6, and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.