Dietary Intervention Study on Liver Health in Young Adults
14 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
100
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Daniel Trimmel, MSc
- Numéro de téléphone: 4824 +43 1 606 68 77
- E-mail: daniel.trimmel@hcw.ac.at
Sauvegarde des contacts de l'étude
- Nom: Agnes Draxler, PhD
- Numéro de téléphone: 4207 +43 1 606 68 77
- E-mail: agnes.draxler@hcw.ac.at
Lieux d'étude
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Austria
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Vienna, Austria, L'Autriche, 1100
- Recrutement
- Hochschule Campus Wien
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Contact:
- Daniel Trimmel, MSc
- Numéro de téléphone: 4824 +43 1 606 68 77
- E-mail: daniel.trimmel@hcw.ac.at
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change From Baseline in Ultrasound-Guided Attenuation Parameter (UGAP)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Visual Liver Steatosis Grade
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change From Baseline in DNA Damage Measured as Percentage of DNA in the Comet Tail
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Agnes Draxler, PhD, Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
- Chercheur principal: Daniel Trimmel, MSc, Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
31 août 2026
Achèvement primaire (Estimé)
1 novembre 2026
Achèvement de l'étude (Estimé)
1 novembre 2026
Dates d'inscription aux études
Première soumission
19 août 2026
Première soumission répondant aux critères de contrôle qualité
25 août 2026
Première publication (Réel)
26 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
15 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
14 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HCW-LIVER-2026
- 26000979 (Autre identifiant: Ethics Committee of Hochschule Campus Wien)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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