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Идёт набор NCT05332613

Diet and Meal Timing in Patients With Metabolic Dysfunction Associated Steatoic Liver Disease

Без фазы С лечением Non-Alcoholic Fatty Liver Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: TRE plus SOC, SOC, TRE.
Кому может быть актуально
Состояния в реестре: Non-Alcoholic Fatty Liver Disease. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Diet and Meal Timing in Patients With Metabolic Dysfunction Associated Steatoic Liver Disease: A Pilot Study

Обзор

This study will assess the impact of time-restricted eating (8 hours of eating each day) with standard of care lifestyle recommendations (hypocaloric, Mediterranean diet and 30 minutes of exercise on at least 5 days/week) on the degree of fat in the liver as measured by magnetic resonance imaging.

Подробное описание

Time-Restricted Eating (TRE) is a form of caloric restriction through daily prolonged fasting that has been shown to lead to weight loss, improved glucose regulation, and suppression of inflammation. Metabolic Dysfunction Associated Steatotic Liver Disease (MASLD) is a metabolic condition that in certain patients can lead to significant morbidity and mortality. The only current treatment for MASLD is weight loss. In the proposed study, the investigators aim to test the hypothesis that TRE will add additional benefit in the treatment of MASLD on top of standard of care diet and lifestyle modifications.

Вмешательства

  • Поведенческое TRE plus SOC
    Participants will undergo time restricted eating (TRE) each day for 12 weeks and will be given lifestyle recommendations with respect to diet (500-1000 kcal) and moderate-intensity exercise (30 minutes).
  • Поведенческое SOC
    Participants will be given lifestyle recommendations with respect to diet (500-1000 kcal) and moderate-intensity exercise (30 minutes).
  • Поведенческое TRE
    Participants will undergo time restricted eating (TRE) each day for 12 weeks plus 4 extra visits with the registered dietician and repeat Fibroscan, InBody composition scan, and MRI-PDFF.

Первичные конечные точки

  • Percentage of Patients Who Achieve At Least 30% Reduction in Liver Fat at 12 Weeks [Срок оценки: 12 weeks]
Вторичные конечные точки (11)
  • Mean Change from Baseline in Quality of Life Score on SF-36 at 12 weeks [Срок оценки: Baseline, 12 weeks]
  • Mean Change from Baseline in Weight at 12 weeks [Срок оценки: Baseline, 12 weeks]
  • Mean Change from Baseline in BMI at 12 weeks [Срок оценки: Baseline, 12 weeks]
  • Mean Change from Baseline in Liver Stiffness on Fibroscan® at 12 weeks [Срок оценки: Baseline, 12 weeks]
  • Mean Change from Baseline in Body Composition Measurements at 12 weeks [Срок оценки: Baseline, 12 weeks]
  • Mean Change from Baseline in aspartate transglutaminase at 12 weeks [Срок оценки: Baseline, 12 weeks]
  • Mean Change from Baseline in alanine transglutaminase at 12 weeks [Срок оценки: Baseline, 12 weeks]
  • Mean Change from Baseline in total bilirubin at 12 weeks [Срок оценки: Baseline, 12 weeks]
  • Mean Change from Baseline in direct bilirubin at 12 weeks [Срок оценки: Baseline, 12 weeks]
  • Mean Change from Baseline in albumin at 12 weeks [Срок оценки: Baseline, 12 weeks]
  • Mean Change from Baseline in total protein at 12 weeks [Срок оценки: Baseline, 12 weeks]

Критерии участия

Критерии включения

  • Age ≥ 18 and < 65 years old
  • Must provide signed written informed consent and agree to comply with the study protocol
  • BMI >25 kg/m²
  • Baseline liver fat content of at least 10% as measured by MRI-PDFF

Критерии исключения

  • Unclear etiology of liver disease
  • Competing etiologies for hepatic steatosis
  • Co-existing causes of chronic liver disease according to standard diagnostic testing including, but not restricted to:
  • Positive hepatitis B surface antigen
  • Positive hepatitis C virus RNA
  • Suspicion of drug-induced liver disease
  • Alcoholic liver disease
  • Autoimmune hepatitis
  • Wilson's disease
  • Hemochromatosis
  • Primary biliary cholangitis or primary sclerosing cholangitis
  • Known or suspected hepatocellular carcinoma
  • Current or recent history (<5 years) of significant alcohol consumption. For men, significant consumption is defined as >30g of alcohol per day. For women, it is defined as >20g of alcohol per day.
  • Compensated and decompensated cirrhosis (clinical and/or histologic evidence of cirrhosis). NASH patients with fibrosis stage = 4 according to the NASH CRN fibrosis staging system are excluded.
  • Reduction in weight by ≥ 5% within the prior 90 days
  • Current fasting for ≥ 12 hours per day on the majority of days each week
  • Pregnant females
  • Mental instability or incompetence, such that the validity of the informed consent or ability to be compliant with the study is uncertain
  • Inability to perform MRI-PDFF and/or study as defined below
  • Inability to medically perform prolonged fasting (i.e. insulin regimen)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Weill Cornell Medicine — New York

Идентификаторы

NCT: NCT05332613 · 21-10024103

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗