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Dietary Intervention Study on Liver Health in Young Adults

2026年9月14日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

100

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • オーストリア
    • Austria
      • Vienna、Austria、オーストリア、1100
        • 募集
        • Hochschule Campus Wien
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

はい

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：防止
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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).
行動：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.
アクティブコンパレータ：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.
行動：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change From Baseline in Ultrasound-Guided Attenuation Parameter (UGAP)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Visual Liver Steatosis Grade
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Change From Baseline in DNA Damage Measured as Percentage of DNA in the Comet Tail
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Hochschule Campus Wien (University of Applied Sciences Campus Vienna)

捜査官

  • 主任研究者：Agnes Draxler, PhD、Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
  • 主任研究者：Daniel Trimmel, MSc、Hochschule Campus Wien (University of Applied Sciences Campus Vienna)

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年8月31日

一次修了 (推定)

2026年11月1日

研究の完了 (推定)

2026年11月1日

試験登録日

最初に提出

2026年8月19日

QC基準を満たした最初の提出物

2026年8月25日

最初の投稿 (実際)

2026年8月26日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月15日

QC基準を満たした最後の更新が送信されました

2026年9月14日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • HCW-LIVER-2026
  • 26000979 (その他の識別子：Ethics Committee of Hochschule Campus Wien)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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