Dietary Intervention Study on Liver Health in Young Adults
14 сентября 2026 г. обновлено: 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.
Обзор исследования
Статус
Рекрутинг
Условия
Тип исследования
Интервенционный
Регистрация (Оцененный)
100
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Daniel Trimmel, MSc
- Номер телефона: 4824 +43 1 606 68 77
- Электронная почта: daniel.trimmel@hcw.ac.at
Учебное резервное копирование контактов
- Имя: Agnes Draxler, PhD
- Номер телефона: 4207 +43 1 606 68 77
- Электронная почта: agnes.draxler@hcw.ac.at
Места учебы
-
-
Austria
-
Vienna, Austria, Австрия, 1100
- Рекрутинг
- Hochschule Campus Wien
-
Контакт:
- Daniel Trimmel, MSc
- Номер телефона: 4824 +43 1 606 68 77
- Электронная почта: daniel.trimmel@hcw.ac.at
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Да
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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).
|
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.
|
|
Активный компаратор: 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.
|
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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change From Baseline in Ultrasound-Guided Attenuation Parameter (UGAP)
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Visual Liver Steatosis Grade
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change From Baseline in DNA Damage Measured as Percentage of DNA in the Comet Tail
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Agnes Draxler, PhD, Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
- Главный следователь: Daniel Trimmel, MSc, Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
31 августа 2026 г.
Первичное завершение (Оцененный)
1 ноября 2026 г.
Завершение исследования (Оцененный)
1 ноября 2026 г.
Даты регистрации исследования
Первый отправленный
19 августа 2026 г.
Впервые представлено, что соответствует критериям контроля качества
25 августа 2026 г.
Первый опубликованный (Действительный)
26 августа 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
15 сентября 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
14 сентября 2026 г.
Последняя проверка
1 сентября 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- HCW-LIVER-2026
- 26000979 (Другой идентификатор: Ethics Committee of Hochschule Campus Wien)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .