Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Dietary Intervention Study on Liver Health in Young Adults

14 de setembro de 2026 atualizado 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

100

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Áustria
    • Austria
      • Vienna, Austria, Áustria, 1100
        • Recrutamento
        • Hochschule Campus Wien
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Sim

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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).
Comportamental: 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 Ativo: 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.
Comportamental: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change From Baseline in Ultrasound-Guided Attenuation Parameter (UGAP)
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Visual Liver Steatosis Grade
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Change From Baseline in DNA Damage Measured as Percentage of DNA in the Comet Tail
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

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)

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

31 de agosto de 2026

Conclusão Primária (Estimado)

1 de novembro de 2026

Conclusão do estudo (Estimado)

1 de novembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

19 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

25 de agosto de 2026

Primeira postagem (Real)

26 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

15 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

14 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever