An interventional study of Personalized Dietary Feedback and Generic Dietary Feedback in MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), MetALD and Steatotic Liver Disease, sponsored by Medical University of Vienna. Not yet recruiting at 1 site in Austria. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Medical University of Vienna · Not applicable, Interventional, and Treatment
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.
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.
Medical University of Vienna is the lead sponsor of 1,109 studies on the registry; 184 are open to participants now.
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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.
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.
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.
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.
Behavioral: Personalized Dietary Feedback
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.
Behavioral: Generic Dietary Feedback
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.
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.
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.
Time frame: 6 months (baseline CAP used for adjustment).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 6 months
Plan to share: No — Patient data can be shared upon reasonable request and after fulfilling all legal and data protection requirements from the EU.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2028, 25 months later.
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 ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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