Dietary Intervention Study on Liver Health in Young Adults
14. září 2026 aktualizováno: 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.
Přehled studie
Postavení
Nábor
Podmínky
Typ studie
Intervenční
Zápis (Odhadovaný)
100
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Daniel Trimmel, MSc
- Telefonní číslo: 4824 +43 1 606 68 77
- E-mail: daniel.trimmel@hcw.ac.at
Studijní záloha kontaktů
- Jméno: Agnes Draxler, PhD
- Telefonní číslo: 4207 +43 1 606 68 77
- E-mail: agnes.draxler@hcw.ac.at
Studijní místa
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Austria
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Vienna, Austria, Rakousko, 1100
- Nábor
- Hochschule Campus Wien
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Kontakt:
- Daniel Trimmel, MSc
- Telefonní číslo: 4824 +43 1 606 68 77
- E-mail: daniel.trimmel@hcw.ac.at
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-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Ano
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Aktivní komparátor: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change From Baseline in Ultrasound-Guided Attenuation Parameter (UGAP)
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Visual Liver Steatosis Grade
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change From Baseline in DNA Damage Measured as Percentage of DNA in the Comet Tail
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Agnes Draxler, PhD, Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
- Vrchní vyšetřovatel: Daniel Trimmel, MSc, Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
31. srpna 2026
Primární dokončení (Odhadovaný)
1. listopadu 2026
Dokončení studie (Odhadovaný)
1. listopadu 2026
Termíny zápisu do studia
První předloženo
19. srpna 2026
První předloženo, které splnilo kritéria kontroly kvality
25. srpna 2026
První zveřejněno (Aktuální)
26. srpna 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
15. září 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
14. září 2026
Naposledy ověřeno
1. září 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- HCW-LIVER-2026
- 26000979 (Jiný identifikátor: Ethics Committee of Hochschule Campus Wien)
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