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NCT07914829
Personalized Dietary Feedback to Reduce Hepatic Steatosis in Patients With MASLD
Conditions: MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), MetALD, Steatotic Liver Disease
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 174
Sponsor: Medical University of Vienna
Location: Medical University of Vienna Vienna State of Vienna
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. 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.
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Source: ClinicalTrials.gov (NCT07914829). StuddyBuddy aggregates publicly available trial information.