Personalized Dietary Feedback to Reduce Hepatic Steatosis in Patients With MASLD (PERSOMA)
Effect of Personalized Dietary and Lifestyle Feedback on Hepatic Steatosis in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Prospective, Randomized Controlled Trial
Metabolic dysfunction-associated steatotic liver disease (MASLD) and combined metabolic dysfunction and alcohol-associated liver disease (MetALD) are common chronic liver diseases associated with metabolic dysfunction and an increased risk of liver-related and cardiovascular complications. Lifestyle modification, particularly dietary changes and increased physical activity, represents a cornerstone of treatment. However, general lifestyle recommendations are often insufficient to achieve sustained improvements.
This prospective, randomized controlled trial aims to investigate whether personalized dietary and lifestyle feedback based on a structured questionnaire is more effective in reducing hepatic steatosis than generic lifestyle recommendations.
A total of 174 patients with MASLD or MetALD will be randomized 1:1 to receive either personalized or generic written feedback at baseline and after 2, 4, and 6 months. Changes in hepatic steatosis, assessed by the controlled attenuation parameter (CAP), will be evaluated over a six-month period.
調査の概要
状態
詳細な説明
This is a prospective, single-center, randomized controlled trial designed to evaluate the effectiveness of personalized dietary and lifestyle feedback compared with generic recommendations in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) or metabolic dysfunction and alcohol-associated liver disease (MetALD).
A total of 174 adult patients with MASLD or MetALD will be randomized in a 1:1 ratio to an intervention group receiving individualized feedback based on a structured dietary and lifestyle questionnaire or a control group receiving standardized written recommendations.
Participants will complete the questionnaire at baseline and after 2, 4, and 6 months, followed by the corresponding written feedback. Clinical, anthropometric, laboratory, and non-invasive liver assessments, including vibration-controlled transient elastography (VCTE) and controlled attenuation parameter (CAP), will be performed at baseline and after six months.
The primary objective is to compare hepatic steatosis between the two groups after six months, adjusting for baseline CAP values. Secondary objectives include assessing changes in body weight, metabolic parameters, liver stiffness, dietary habits, physical activity, and health-related quality of life.
The study aims to determine whether a simple, scalable, personalized feedback approach can improve lifestyle management in patients with MASLD or MetALD.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Georg Semmler, MD PhD
- 電話番号：+4314040047410
- メール：georg.semmler@meduniwien.ac.at
研究場所
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State of Vienna
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Vienna、State of Vienna、オーストリア、1090
- Medical University of Vienna
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コンタクト：
- Georg Semmler, MD PhD
- 電話番号：+4314040047410
- メール：sld@meduniwien.ac.at
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age 18-80 years.
- Controlled attenuation parameter (CAP) >248 dB/m.
- Sufficient German language proficiency to independently complete the questionnaires.
- Written informed consent to participate in the study.
Exclusion Criteria:
- Other active chronic liver disease.
- Significant alcohol consumption, defined as ≥50 g/day in women or ≥60 g/day in men.
- Pregnancy or breastfeeding.
- Type 1 diabetes mellitus.
- Initiation or dose modification of GLP-1 receptor agonists or other weight-modifying pharmacological therapies within the previous three months.
- Planned bariatric surgery during study participation.
- Severe or unstable medical condition that, in the investigator's judgment, may interfere with study participation or interpretation of study results.
研究計画
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：処理
- 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 |
|---|---|
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実験的：Personalized Dietary Feedback
Participants will receive personalized written dietary feedback based on their individual responses to a structured questionnaire. The feedback will include tailored recommendations regarding dietary habits. Updated personalized feedback will be provided at baseline and after 2, 4, and 6 months. |
Participants receive individualized written dietary feedback based on their responses to a structured dietary questionnaire. The feedback includes an assessment of individual dietary habits, a visual representation of dietary patterns, and personalized recommendations to improve food choices and dietary quality. Updated feedback is provided at baseline and after 2, 4, and 6 months based on repeated questionnaire assessments. |
|
アクティブコンパレータ：Generic Dietary Feedback
Participants will receive standardized written dietary recommendations independent of their individual questionnaire responses. Generic feedback will be provided at baseline and after 2, 4, and 6 months. |
Participants receive standardized written dietary recommendations based on general nutritional guidelines. The information is identical for all participants in the control group and is not tailored to individual dietary habits or questionnaire responses. The same generic dietary information is provided at baseline and after 2, 4, and 6 months. |
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 |
|---|---|---|
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Hepatic Steatosis at 6 Months, Assessed by Controlled Attenuation Parameter (CAP) Using Vibration-Controlled Transient Elastography (VCTE)
時間枠：6 months (baseline CAP used for adjustment).
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Hepatic steatosis will be quantified using the controlled attenuation parameter (CAP), measured in decibels per meter (dB/m) by vibration-controlled transient elastography (VCTE). The outcome measure is the CAP value at 6 months. The between-group difference at 6 months will be evaluated using analysis of covariance (ANCOVA), with baseline CAP included as a covariate. CAP is the only measurement reported for this outcome. |
6 months (baseline CAP used for adjustment).
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Body Weight from Baseline to 6 Months
時間枠：Baseline and 6 months
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Body weight will be measured in kilograms (kg). Change will be calculated as body weight at 6 months minus baseline body weight. |
Baseline and 6 months
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Percentage Change in Body Weight from Baseline to 6 Months
時間枠：Baseline and 6 months
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Percentage change in body weight will be calculated as [(body weight at 6 months - baseline body weight) / baseline body weight] × 100. |
Baseline and 6 months
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Change in Waist Circumference from Baseline to 6 Months
時間枠：Baseline and 6 months
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Waist circumference will be measured in centimeters (cm). Absolute change from baseline to 6 months will be reported. |
Baseline and 6 months
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Change in Hip Circumference from Baseline to 6 Months
時間枠：Baseline and 6 months
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Hip circumference will be measured in centimeters (cm). Absolute change from baseline to 6 months will be reported. |
Baseline and 6 months
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Change in Alanine Aminotransferase (ALT) from Baseline to 6 Months
時間枠：Baseline and 6 months
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Serum ALT will be measured in units per liter (U/L). Absolute change from baseline to 6 months will be reported. |
Baseline and 6 months
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Change in Aspartate Aminotransferase (AST) from Baseline to 6 Months
時間枠：Baseline and 6 months
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Serum AST will be measured in units per liter (U/L). Absolute change from baseline to 6 months will be reported. |
Baseline and 6 months
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Change in Gamma-Glutamyl Transferase (GGT) from Baseline to 6 Months
時間枠：Baseline and 6 months
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Serum GGT will be measured in units per liter (U/L). Absolute change from baseline to 6 months will be reported. |
Baseline and 6 months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
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?
IPD プランの説明
Patient data can be shared upon reasonable request and after fulfilling all legal and data protection requirements from the EU.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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