Dietary Intervention Study on Liver Health in Young Adults
2026년 9월 14일 업데이트: 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.
연구 개요
상태
모병
정황
연구 유형
중재적
등록 (추정된)
100
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Daniel Trimmel, MSc
- 전화번호: 4824 +43 1 606 68 77
- 이메일: daniel.trimmel@hcw.ac.at
연구 연락처 백업
- 이름: Agnes Draxler, PhD
- 전화번호: 4207 +43 1 606 68 77
- 이메일: agnes.draxler@hcw.ac.at
연구 장소
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Austria
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Vienna, Austria, 오스트리아, 1100
- 모병
- Hochschule Campus Wien
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연락하다:
- Daniel Trimmel, MSc
- 전화번호: 4824 +43 1 606 68 77
- 이메일: daniel.trimmel@hcw.ac.at
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
예
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline in Ultrasound-Guided Attenuation Parameter (UGAP)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Visual Liver Steatosis Grade
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline in DNA Damage Measured as Percentage of DNA in the Comet Tail
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Agnes Draxler, PhD, Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
- 수석 연구원: Daniel Trimmel, MSc, Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 8월 31일
기본 완료 (추정된)
2026년 11월 1일
연구 완료 (추정된)
2026년 11월 1일
연구 등록 날짜
최초 제출
2026년 8월 19일
QC 기준을 충족하는 최초 제출
2026년 8월 25일
처음 게시됨 (실제)
2026년 8월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 14일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- HCW-LIVER-2026
- 26000979 (기타 식별자: Ethics Committee of Hochschule Campus Wien)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
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아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .