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Dietary Intervention Study on Liver Health in Young Adults

14 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

100

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Agnes Draxler, PhD
  • Número de teléfono: 4207 +43 1 606 68 77
  • Correo electrónico: agnes.draxler@hcw.ac.at

Ubicaciones de estudio

  • Austria
    • Austria
      • Vienna, Austria, Austria, 1100
        • Reclutamiento
        • Hochschule Campus Wien
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

Sí

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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).
Conductual: Mediterranean Diet Intervention
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.
Comparador activo: 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.
Conductual: General Healthy Diet Intervention
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in Ultrasound-Guided Attenuation Parameter (UGAP)
Periodo de tiempo: Baseline, Week 6, and Week 12
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.
Baseline, Week 6, and Week 12

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Visual Liver Steatosis Grade
Periodo de tiempo: Baseline, Week 6, and Week 12
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.
Baseline, Week 6, and Week 12
Change From Baseline in Urinary Albumin Concentration
Periodo de tiempo: Baseline, Week 6, and Week 12
Urinary albumin concentration will be assessed in spontaneous urine samples. Change from baseline will be assessed at Week 6 and Week 12.
Baseline, Week 6, and Week 12
Change From Baseline in Aspartate Aminotransferase (AST)
Periodo de tiempo: Baseline, Week 6, and Week 12
Aspartate aminotransferase (AST) will be assessed in blood samples. Change from baseline will be assessed at Week 6 and Week 12.
Baseline, Week 6, and Week 12
Change From Baseline in Alanine Aminotransferase (ALT)
Periodo de tiempo: Baseline, Week 6, and Week 12
Alanine aminotransferase (ALT) will be assessed in blood samples. Change from baseline will be assessed at Week 6 and Week 12.
Baseline, Week 6, and Week 12
Change From Baseline in Urinary Creatinine Concentration
Periodo de tiempo: Baseline, Week 6, and Week 12
Urinary creatinine concentration will be assessed in spontaneous urine samples. Change from baseline will be assessed at Week 6 and Week 12.
Baseline, Week 6, and Week 12
Change From Baseline in Gamma-Glutamyl Transferase (GGT)
Periodo de tiempo: 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.
Baseline, Week 6, and Week 12
Change From Baseline in Alkaline Phosphatase (ALP)
Periodo de tiempo: Baseline, Week 6, and Week 12
Alkaline phosphatase (ALP) will be assessed in blood samples. Change from baseline will be assessed at Week 6 and Week 12.
Baseline, Week 6, and Week 12
Change From Baseline in Bilirubin
Periodo de tiempo: Baseline, Week 6, and Week 12
Bilirubin will be assessed in blood samples. Change from baseline will be assessed at Week 6 and Week 12.
Baseline, Week 6, and Week 12
Change From Baseline in Triglycerides
Periodo de tiempo: Baseline, Week 6, and Week 12
Triglycerides will be assessed in blood samples. Change from baseline will be assessed at Week 6 and Week 12.
Baseline, Week 6, and Week 12
Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)
Periodo de tiempo: Baseline, Week 6, and Week 12
High-density lipoprotein cholesterol (HDL-C) will be assessed in blood samples. Change from baseline will be assessed at Week 6 and Week 12.
Baseline, Week 6, and Week 12
Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Periodo de tiempo: Baseline, Week 6, and Week 12
Low-density lipoprotein cholesterol (LDL-C) will be assessed in blood samples. Change from baseline will be assessed at Week 6 and Week 12.
Baseline, Week 6, and Week 12
Change From Baseline in C-Reactive Protein (CRP)
Periodo de tiempo: Baseline, Week 6, and Week 12
C-reactive protein (CRP) will be assessed in blood samples. Change from baseline will be assessed at Week 6 and Week 12.
Baseline, Week 6, and Week 12
Change From Baseline in Glycated Hemoglobin (HbA1c)
Periodo de tiempo: Baseline, Week 6, and Week 12
Glycated hemoglobin (HbA1c) will be assessed in blood samples. Change from baseline will be assessed at Week 6 and Week 12.
Baseline, Week 6, and Week 12
Change From Baseline in Body Fat Mass Assessed by Bioelectrical Impedance Analysis (BIA)
Periodo de tiempo: Baseline, Week 6, and Week 12
Body fat mass will be assessed using bioelectrical impedance analysis (BIA). Change from baseline will be assessed at Week 6 and Week 12.
Baseline, Week 6, and Week 12
Change From Baseline in Skeletal Muscle Mass Assessed by Bioelectrical Impedance Analysis (BIA)
Periodo de tiempo: Baseline, Week 6, and Week 12
Skeletal muscle mass will be assessed using bioelectrical impedance analysis (BIA). Change from baseline will be assessed at Week 6 and Week 12.
Baseline, Week 6, and Week 12
Change From Baseline in Total Body Water Assessed by Bioelectrical Impedance Analysis (BIA)
Periodo de tiempo: Baseline, Week 6, and Week 12
Total body water will be assessed using bioelectrical impedance analysis (BIA). Change from baseline will be assessed at Week 6 and Week 12.
Baseline, Week 6, and Week 12

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in DNA Damage Measured as Percentage of DNA in the Comet Tail
Periodo de tiempo: Baseline, Week 6, and Week 12
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.
Baseline, Week 6, and Week 12
Change From Baseline in Malondialdehyde (MDA) Concentration
Periodo de tiempo: Baseline, Week 6, and Week 12
Malondialdehyde (MDA) concentration will be assessed as a biomarker of oxidative stress. Change from baseline will be assessed at Week 6 and Week 12.
Baseline, Week 6, and Week 12
Change From Baseline in Ferric Reducing Antioxidant Power (FRAP)
Periodo de tiempo: Baseline, Week 6, and Week 12
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.
Baseline, Week 6, and Week 12
Change From Baseline in Plasma Reduced Glutathione (GSH) Concentration
Periodo de tiempo: Baseline, Week 6, and Week 12
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.
Baseline, Week 6, and Week 12
Change From Baseline in Plasma Oxidized Glutathione (GSSG) Concentration
Periodo de tiempo: Baseline, Week 6, and Week 12
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.
Baseline, Week 6, and Week 12
Change From Baseline in Waist Circumference
Periodo de tiempo: Baseline, Week 6, and Week 12
Waist circumference will be measured at each study visit. Change from baseline will be assessed at Week 6 and Week 12.
Baseline, Week 6, and Week 12
Change From Baseline in Hip Circumference
Periodo de tiempo: Baseline, Week 6, and Week 12
Hip circumference will be measured at each study visit. Change from baseline will be assessed at Week 6 and Week 12.
Baseline, Week 6, and Week 12

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Hochschule Campus Wien (University of Applied Sciences Campus Vienna)

Investigadores

  • Investigador principal: Agnes Draxler, PhD, Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
  • Investigador principal: Daniel Trimmel, MSc, Hochschule Campus Wien (University of Applied Sciences Campus Vienna)

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

31 de agosto de 2026

Finalización primaria (Estimado)

1 de noviembre de 2026

Finalización del estudio (Estimado)

1 de noviembre de 2026

Fechas de registro del estudio

Enviado por primera vez

19 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

25 de agosto de 2026

Publicado por primera vez (Actual)

26 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • HCW-LIVER-2026
  • 26000979 (Otro identificador: Ethics Committee of Hochschule Campus Wien)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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