MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)PERSOMANCT07914829
Personalized Dietary Feedback to Reduce Hepatic Steatosis in Patients With MASLD
A study testing Personalized Dietary Feedback and Generic Dietary Feedback in people with MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease) and MetALD, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Metabolic dysfunction-associated steatotic liver disease (MASLD) and combined metabolic dysfunction and alcohol-associated liver disease (MetALD) are common chronic liver diseases associated with metabolic dysfunction and an increased risk of liver-related and cardiovascular complications. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), MetALD, Steatotic Liver Disease
- What is being tested?
- Personalized Dietary Feedback and Generic Dietary Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteAustria
- Study dates
- 1 Nov 2026to 31 Dec 2028
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years.
- Controlled attenuation parameter (CAP) >248 dB/m.
- Sufficient German language proficiency to independently complete the questionnaires.
- Written informed consent to participate in the study.
Who cannot join
- Other active chronic liver disease.
- Significant alcohol consumption, defined as ≥50 g/day in women or ≥60 g/day in men.
- Pregnancy or breastfeeding.
- Type 1 diabetes mellitus.
- Initiation or dose modification of GLP-1 receptor agonists or other weight-modifying pharmacological therapies within the previous three months.
- Planned bariatric surgery during study participation.
- Severe or unstable medical condition that, in the investigator's judgment, may interfere with study participation or interpretation of study results.
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
Medical University of Vienna
Vienna, State of Vienna, 1090
Georg Semmler, MD PhD, +4314040047410, sld@meduniwien.ac.at
About this study
Official title: Effect of Personalized Dietary and Lifestyle Feedback on Hepatic Steatosis in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Prospective, Randomized Controlled Trial
Metabolic dysfunction-associated steatotic liver disease (MASLD) and combined metabolic dysfunction and alcohol-associated liver disease (MetALD) are common chronic liver diseases associated with metabolic dysfunction and an increased risk of liver-related and cardiovascular complications. Lifestyle modification, particularly dietary changes and increased physical activity, represents a cornerstone of treatment. However, general lifestyle recommendations are often insufficient to achieve sustained improvements.
This prospective, randomized controlled trial aims to investigate whether personalized dietary and lifestyle feedback based on a structured questionnaire is more effective in reducing hepatic steatosis than generic lifestyle recommendations.
A total of 174 patients with MASLD or MetALD will be randomized 1:1 to receive either personalized or generic written feedback at baseline and after 2, 4, and 6 months. Changes in hepatic steatosis, assessed by the controlled attenuation parameter (CAP), will be evaluated over a six-month period.
Read the detailed description
This is a prospective, single-center, randomized controlled trial designed to evaluate the effectiveness of personalized dietary and lifestyle feedback compared with generic recommendations in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) or metabolic dysfunction and alcohol-associated liver disease (MetALD).
A total of 174 adult patients with MASLD or MetALD will be randomized in a 1:1 ratio to an intervention group receiving individualized feedback based on a structured dietary and lifestyle questionnaire or a control group receiving standardized written recommendations.
Participants will complete the questionnaire at baseline and after 2, 4, and 6 months, followed by the corresponding written feedback. Clinical, anthropometric, laboratory, and non-invasive liver assessments, including vibration-controlled transient elastography (VCTE) and controlled attenuation parameter (CAP), will be performed at baseline and after six months.
The primary objective is to compare hepatic steatosis between the two groups after six months, adjusting for baseline CAP values. Secondary objectives include assessing changes in body weight, metabolic parameters, liver stiffness, dietary habits, physical activity, and health-related quality of life.
The study aims to determine whether a simple, scalable, personalized feedback approach can improve lifestyle management in patients with MASLD or MetALD.
- Conditions
- MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), MetALD, Steatotic Liver Disease
- Being tested
- Personalized Dietary Feedback, Generic Dietary Feedback
- Keywords
- MASLD, MetALD, SLD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Dietary FeedbackBehavioural
Participants receive individualized written dietary feedback based on their responses to a structured dietary questionnaire. The feedback includes an assessment of individual dietary habits, a visual representation of dietary patterns, and personalized recommendations to improve food choices and dietary quality. Updated feedback is provided at baseline and after 2, 4, and 6 months based on repeated questionnaire assessments.
Generic Dietary FeedbackBehavioural
Participants receive standardized written dietary recommendations based on general nutritional guidelines. The information is identical for all participants in the control group and is not tailored to individual dietary habits or questionnaire responses. The same generic dietary information is provided at baseline and after 2, 4, and 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Dietary Feedback | Experimental | Participants will receive personalized written dietary feedback based on their individual responses to a structured questionnaire. The feedback will include tailored recommendations regarding dietary habits. Updated personalized feedback will be provided at baseline and after 2, 4, and 6 months. Receives: Behavioral: Personalized Dietary Feedback |
| Generic Dietary Feedback | Active comparator | Participants will receive standardized written dietary recommendations independent of their individual questionnaire responses. Generic feedback will be provided at baseline and after 2, 4, and 6 months. Receives: Behavioral: Generic Dietary Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic Steatosis at 6 Months, Assessed by Controlled Attenuation Parameter (CAP) Using Vibration-Controlled Transient Elastography (VCTE)
Hepatic steatosis will be quantified using the controlled attenuation parameter (CAP), measured in decibels per meter (dB/m) by vibration-controlled transient elastography (VCTE). The outcome measure is the CAP value at 6 months. The between-group difference at 6 months will be evaluated using analysis of covariance (ANCOVA), with baseline CAP included as a covariate. CAP is the only measurement reported for this outcome.
Measured: 6 months (baseline CAP used for adjustment).
Secondary outcomes (7)
Change in Body Weight from Baseline to 6 Months
Body weight will be measured in kilograms (kg). Change will be calculated as body weight at 6 months minus baseline body weight.
Measured: Baseline and 6 months
Percentage Change in Body Weight from Baseline to 6 Months
Percentage change in body weight will be calculated as [(body weight at 6 months - baseline body weight) / baseline body weight] × 100.
Measured: Baseline and 6 months
Change in Waist Circumference from Baseline to 6 Months
Waist circumference will be measured in centimeters (cm). Absolute change from baseline to 6 months will be reported.
Measured: Baseline and 6 months
Change in Hip Circumference from Baseline to 6 Months
Hip circumference will be measured in centimeters (cm). Absolute change from baseline to 6 months will be reported.
Measured: Baseline and 6 months
Change in Alanine Aminotransferase (ALT) from Baseline to 6 Months
Serum ALT will be measured in units per liter (U/L). Absolute change from baseline to 6 months will be reported.
Measured: Baseline and 6 months
Change in Aspartate Aminotransferase (AST) from Baseline to 6 Months
Serum AST will be measured in units per liter (U/L). Absolute change from baseline to 6 months will be reported.
Measured: Baseline and 6 months
Change in Gamma-Glutamyl Transferase (GGT) from Baseline to 6 Months
Serum GGT will be measured in units per liter (U/L). Absolute change from baseline to 6 months will be reported.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)Studies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- University of Vienna
- Responsible party
- Principal investigator, Georg Semmler, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914829
- Sponsor's protocol ID
- 1770/2026
- Acronym
- PERSOMA
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data can be shared upon reasonable request and after fulfilling all legal and data protection requirements from the EU.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Personalized Dietary and Lifestyle Feedback on Hepatic Steatosis in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07914829
- Acronym / sponsor ID
- PERSOMA / 1770/2026
- Conditions
- MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), MetALD, Steatotic Liver Disease
- Keywords
- MASLD, MetALD, SLD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- University of Vienna
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 Nov 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.
Metabolic dysfunction-associated steatotic liver disease (MASLD) and combined metabolic dysfunction and alcohol-associated liver disease (MetALD) are common chronic liver diseases associated with metabolic dysfunction and an increased risk of liver-related and cardiovascular complications. Lifestyle modification, particularly dietary changes and increased physical activity, represents a cornerstone of treatment. However, general lifestyle recommendations are often insufficient to achieve sustained improvements.
This prospective, randomized controlled trial aims to investigate whether personalized dietary and lifestyle feedback based on a structured questionnaire is more effective in reducing hepatic steatosis than generic lifestyle recommendations.
A total of 174 patients with MASLD or MetALD will be randomized 1:1 to receive either personalized or generic written feedback at baseline and after 2, 4, and 6 months. Changes in hepatic steatosis, assessed by the controlled attenuation parameter (CAP), will be evaluated over a six-month period.
Detailed description
This is a prospective, single-center, randomized controlled trial designed to evaluate the effectiveness of personalized dietary and lifestyle feedback compared with generic recommendations in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) or metabolic dysfunction and alcohol-associated liver disease (MetALD).
A total of 174 adult patients with MASLD or MetALD will be randomized in a 1:1 ratio to an intervention group receiving individualized feedback based on a structured dietary and lifestyle questionnaire or a control group receiving standardized written recommendations.
Participants will complete the questionnaire at baseline and after 2, 4, and 6 months, followed by the corresponding written feedback. Clinical, anthropometric, laboratory, and non-invasive liver assessments, including vibration-controlled transient elastography (VCTE) and controlled attenuation parameter (CAP), will be performed at baseline and after six months.
The primary objective is to compare hepatic steatosis between the two groups after six months, adjusting for baseline CAP values. Secondary objectives include assessing changes in body weight, metabolic parameters, liver stiffness, dietary habits, physical activity, and health-related quality of life.
The study aims to determine whether a simple, scalable, personalized feedback approach can improve lifestyle management in patients with MASLD or MetALD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized Dietary Feedback | Experimental | Behavioral: Personalized Dietary FeedbackParticipants will receive personalized written dietary feedback based on their individual responses to a structured questionnaire. The feedback will include tailored recommendations regarding dietary habits. Updated personalized feedback will be provided at baseline and after 2, 4, and 6 months. |
| Generic Dietary Feedback | Active comparator | Behavioral: Generic Dietary FeedbackParticipants will receive standardized written dietary recommendations independent of their individual questionnaire responses. Generic feedback will be provided at baseline and after 2, 4, and 6 months. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-80 years.
- Controlled attenuation parameter (CAP) >248 dB/m.
- Sufficient German language proficiency to independently complete the questionnaires.
- Written informed consent to participate in the study.
Key exclusion criteria (7 listed)
- Other active chronic liver disease.
- Significant alcohol consumption, defined as ≥50 g/day in women or ≥60 g/day in men.
- Pregnancy or breastfeeding.
- Type 1 diabetes mellitus.
- Initiation or dose modification of GLP-1 receptor agonists or other weight-modifying pharmacological therapies within the previous three months.
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 |
|---|---|---|
| Personalized Dietary FeedbackParticipants receive individualized written dietary feedback based on their responses to a structured dietary questionnaire. The feedback includes an assessment of individual dietary habits, a visual representation of dietary patterns, and personalized recommendations to improve food choices and dietary quality. Updated feedback is provided at baseline and after 2, 4, and 6 months based on repeated questionnaire assessments. | Behavioural | Personalized Dietary Feedback |
| Generic Dietary FeedbackParticipants receive standardized written dietary recommendations based on general nutritional guidelines. The information is identical for all participants in the control group and is not tailored to individual dietary habits or questionnaire responses. The same generic dietary information is provided at baseline and after 2, 4, and 6 months. | Behavioural | Generic Dietary Feedback |
Primary outcome
Hepatic Steatosis at 6 Months, Assessed by Controlled Attenuation Parameter (CAP) Using Vibration-Controlled Transient Elastography (VCTE)
Time frame: 6 months (baseline CAP used for adjustment).
Hepatic steatosis will be quantified using the controlled attenuation parameter (CAP), measured in decibels per meter (dB/m) by vibration-controlled transient elastography (VCTE). The outcome measure is the CAP value at 6 months. The between-group difference at 6 months will be evaluated using analysis of covariance (ANCOVA), with baseline CAP included as a covariate. CAP is the only measurement reported for this outcome.
7 secondary outcomes
Change in Body Weight from Baseline to 6 Months
Time frame: Baseline and 6 months
Percentage Change in Body Weight from Baseline to 6 Months
Time frame: Baseline and 6 months
Change in Waist Circumference from Baseline to 6 Months
Time frame: Baseline and 6 months
Change in Hip Circumference from Baseline to 6 Months
Time frame: Baseline and 6 months
Change in Alanine Aminotransferase (ALT) from Baseline to 6 Months
Time frame: Baseline and 6 months
Change in Aspartate Aminotransferase (AST) from Baseline to 6 Months
Time frame: Baseline and 6 months
Change in Gamma-Glutamyl Transferase (GGT) from Baseline to 6 Months
Time frame: Baseline and 6 months
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 4 Nov 2026.
- Individual participant dataSharing planned: No. Patient data can be shared upon reasonable request and after fulfilling all legal and data protection requirements from the EU.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Dietary Feedback and Generic Dietary Feedback in people with MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease) and MetALD, run by Medical University of 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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 4 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 Georg Semmler, MD PhD (+4314040047410, georg.semmler@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatic Steatosis at 6 Months, Assessed by Controlled Attenuation Parameter (CAP) Using Vibration-Controlled Transient Elastography (VCTE) (time frame: 6 months (baseline CAP used for adjustment).). 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 4 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.