Dietary Intervention Study on Liver Health in Young Adults
14 settembre 2026 aggiornato da: Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
100
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Daniel Trimmel, MSc
- Numero di telefono: 4824 +43 1 606 68 77
- Email: daniel.trimmel@hcw.ac.at
Backup dei contatti dello studio
- Nome: Agnes Draxler, PhD
- Numero di telefono: 4207 +43 1 606 68 77
- Email: agnes.draxler@hcw.ac.at
Luoghi di studio
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Austria
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Vienna, Austria, Austria, 1100
- Reclutamento
- Hochschule Campus Wien
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Contatto:
- Daniel Trimmel, MSc
- Numero di telefono: 4824 +43 1 606 68 77
- Email: daniel.trimmel@hcw.ac.at
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Sì
Descrizione
Inclusion Criteria:
- Age 20 to 30 years
- Currently enrolled as a student
- Body mass index (BMI) less than or equal to 29 kg/m^2
- 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
Exclusion Criteria:
- 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
- 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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Mediterranean Diet Intervention
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).
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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.
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Comparatore attivo: Control Group - General Dietary Recommendations
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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change From Baseline in Ultrasound-Guided Attenuation Parameter (UGAP)
Lasso di tempo: Baseline, Week 6, and Week 12
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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.
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Baseline, Week 6, and Week 12
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Visual Liver Steatosis Grade
Lasso di tempo: Baseline, Week 6, and Week 12
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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.
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Baseline, Week 6, and Week 12
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Change From Baseline in Urinary Albumin Concentration
Lasso di tempo: Baseline, Week 6, and Week 12
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Urinary albumin concentration will be assessed in spontaneous urine samples.
Change from baseline will be assessed at Week 6 and Week 12.
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Baseline, Week 6, and Week 12
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Change From Baseline in Aspartate Aminotransferase (AST)
Lasso di tempo: Baseline, Week 6, and Week 12
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Aspartate aminotransferase (AST) will be assessed in blood samples.
Change from baseline will be assessed at Week 6 and Week 12.
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Baseline, Week 6, and Week 12
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Change From Baseline in Alanine Aminotransferase (ALT)
Lasso di tempo: Baseline, Week 6, and Week 12
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Alanine aminotransferase (ALT) will be assessed in blood samples.
Change from baseline will be assessed at Week 6 and Week 12.
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Baseline, Week 6, and Week 12
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Change From Baseline in Urinary Creatinine Concentration
Lasso di tempo: Baseline, Week 6, and Week 12
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Urinary creatinine concentration will be assessed in spontaneous urine samples.
Change from baseline will be assessed at Week 6 and Week 12.
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Baseline, Week 6, and Week 12
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Change From Baseline in Gamma-Glutamyl Transferase (GGT)
Lasso di tempo: Baseline, Week 6, and Week 12
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Gamma-glutamyl transferase (GGT) will be assessed in blood samples.
Change from baseline will be assessed at Week 6 and Week 12.
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Baseline, Week 6, and Week 12
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Change From Baseline in Alkaline Phosphatase (ALP)
Lasso di tempo: Baseline, Week 6, and Week 12
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Alkaline phosphatase (ALP) will be assessed in blood samples.
Change from baseline will be assessed at Week 6 and Week 12.
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Baseline, Week 6, and Week 12
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Change From Baseline in Bilirubin
Lasso di tempo: Baseline, Week 6, and Week 12
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Bilirubin will be assessed in blood samples.
Change from baseline will be assessed at Week 6 and Week 12.
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Baseline, Week 6, and Week 12
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Change From Baseline in Triglycerides
Lasso di tempo: Baseline, Week 6, and Week 12
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Triglycerides will be assessed in blood samples.
Change from baseline will be assessed at Week 6 and Week 12.
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Baseline, Week 6, and Week 12
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Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)
Lasso di tempo: Baseline, Week 6, and Week 12
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High-density lipoprotein cholesterol (HDL-C) will be assessed in blood samples.
Change from baseline will be assessed at Week 6 and Week 12.
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Baseline, Week 6, and Week 12
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Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Lasso di tempo: Baseline, Week 6, and Week 12
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Low-density lipoprotein cholesterol (LDL-C) will be assessed in blood samples.
Change from baseline will be assessed at Week 6 and Week 12.
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Baseline, Week 6, and Week 12
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Change From Baseline in C-Reactive Protein (CRP)
Lasso di tempo: Baseline, Week 6, and Week 12
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C-reactive protein (CRP) will be assessed in blood samples.
Change from baseline will be assessed at Week 6 and Week 12.
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Baseline, Week 6, and Week 12
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Change From Baseline in Glycated Hemoglobin (HbA1c)
Lasso di tempo: Baseline, Week 6, and Week 12
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Glycated hemoglobin (HbA1c) will be assessed in blood samples.
Change from baseline will be assessed at Week 6 and Week 12.
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Baseline, Week 6, and Week 12
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Change From Baseline in Body Fat Mass Assessed by Bioelectrical Impedance Analysis (BIA)
Lasso di tempo: Baseline, Week 6, and Week 12
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Body fat mass will be assessed using bioelectrical impedance analysis (BIA).
Change from baseline will be assessed at Week 6 and Week 12.
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Baseline, Week 6, and Week 12
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Change From Baseline in Skeletal Muscle Mass Assessed by Bioelectrical Impedance Analysis (BIA)
Lasso di tempo: Baseline, Week 6, and Week 12
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Skeletal muscle mass will be assessed using bioelectrical impedance analysis (BIA).
Change from baseline will be assessed at Week 6 and Week 12.
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Baseline, Week 6, and Week 12
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Change From Baseline in Total Body Water Assessed by Bioelectrical Impedance Analysis (BIA)
Lasso di tempo: Baseline, Week 6, and Week 12
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Total body water will be assessed using bioelectrical impedance analysis (BIA).
Change from baseline will be assessed at Week 6 and Week 12.
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Baseline, Week 6, and Week 12
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change From Baseline in DNA Damage Measured as Percentage of DNA in the Comet Tail
Lasso di tempo: Baseline, Week 6, and Week 12
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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.
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Baseline, Week 6, and Week 12
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Change From Baseline in Malondialdehyde (MDA) Concentration
Lasso di tempo: Baseline, Week 6, and Week 12
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Malondialdehyde (MDA) concentration will be assessed as a biomarker of oxidative stress.
Change from baseline will be assessed at Week 6 and Week 12.
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Baseline, Week 6, and Week 12
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Change From Baseline in Ferric Reducing Antioxidant Power (FRAP)
Lasso di tempo: Baseline, Week 6, and Week 12
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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.
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Baseline, Week 6, and Week 12
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Change From Baseline in Plasma Reduced Glutathione (GSH) Concentration
Lasso di tempo: Baseline, Week 6, and Week 12
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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.
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Baseline, Week 6, and Week 12
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Change From Baseline in Plasma Oxidized Glutathione (GSSG) Concentration
Lasso di tempo: Baseline, Week 6, and Week 12
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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.
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Baseline, Week 6, and Week 12
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Change From Baseline in Waist Circumference
Lasso di tempo: Baseline, Week 6, and Week 12
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Waist circumference will be measured at each study visit.
Change from baseline will be assessed at Week 6 and Week 12.
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Baseline, Week 6, and Week 12
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Change From Baseline in Hip Circumference
Lasso di tempo: Baseline, Week 6, and Week 12
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Hip circumference will be measured at each study visit.
Change from baseline will be assessed at Week 6 and Week 12.
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Baseline, Week 6, and Week 12
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Agnes Draxler, PhD, Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
- Investigatore principale: Daniel Trimmel, MSc, Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
31 agosto 2026
Completamento primario (Stimato)
1 novembre 2026
Completamento dello studio (Stimato)
1 novembre 2026
Date di iscrizione allo studio
Primo inviato
19 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
25 agosto 2026
Primo Inserito (Effettivo)
26 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
15 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
14 settembre 2026
Ultimo verificato
1 settembre 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HCW-LIVER-2026
- 26000979 (Altro identificatore: Ethics Committee of Hochschule Campus Wien)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .