Dietary Intervention Study on Liver Health in Young Adults
14 września 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Rekrutacyjny
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Szacowany)
100
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Daniel Trimmel, MSc
- Numer telefonu: 4824 +43 1 606 68 77
- E-mail: daniel.trimmel@hcw.ac.at
Kopia zapasowa kontaktu do badania
- Nazwa: Agnes Draxler, PhD
- Numer telefonu: 4207 +43 1 606 68 77
- E-mail: agnes.draxler@hcw.ac.at
Lokalizacje studiów
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Austria
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Vienna, Austria, Austria, 1100
- Rekrutacyjny
- Hochschule Campus Wien
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Kontakt:
- Daniel Trimmel, MSc
- Numer telefonu: 4824 +43 1 606 68 77
- E-mail: daniel.trimmel@hcw.ac.at
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Tak
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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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Aktywny komparator: 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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change From Baseline in Ultrasound-Guided Attenuation Parameter (UGAP)
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Visual Liver Steatosis Grade
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: Baseline, Week 6, and Week 12
|
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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change From Baseline in DNA Damage Measured as Percentage of DNA in the Comet Tail
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Główny śledczy: Agnes Draxler, PhD, Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
- Główny śledczy: Daniel Trimmel, MSc, Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
31 sierpnia 2026
Zakończenie podstawowe (Szacowany)
1 listopada 2026
Ukończenie studiów (Szacowany)
1 listopada 2026
Daty rejestracji na studia
Pierwszy przesłany
19 sierpnia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
25 sierpnia 2026
Pierwszy wysłany (Rzeczywisty)
26 sierpnia 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
15 września 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
14 września 2026
Ostatnia weryfikacja
1 września 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- HCW-LIVER-2026
- 26000979 (Inny identyfikator: Ethics Committee of Hochschule Campus Wien)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .