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Набор скоро начнётся NCT07285135

Dietary Glycine Supplementation in Metabolic Dysfunction-associated Steatotic Liver Disease

Без фазы С лечением Metabolic Dysfunction Associated 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: Glycine, Placebo.
Кому может быть актуально
Состояния в реестре: Metabolic Dysfunction Associated Fatty Liver Disease. Базовые параметры: 21 лет — 70 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Investigating the Effects of Dietary Glycine Supplementation in Patients With Metabolic Dysfunction-associated Steatotic Liver Disease

Обзор

The purpose of this research study is to determine whether taking glycine, a naturally occurring amino acid, as a supplement improves liver health measurements in individuals with Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD). This project will be divided into two parts. The first part will be a case-control study comparing parameters of glycine-dependent metabolic pathways between individuals with MASLD and healthy controls. The second part will be a randomized placebo-controlled trial (RCT) to evaluate the impact of 26-week dietary glycine supplementation on parameters of liver health versus 26-week placebo in patients with MASLD.

Подробное описание

This study will recruit 60 participants with MASLD and 30 healthy controls.

Following written informed consent, subjects will be screened. Eligible study subjects will return to undergo MRI scans of the abdomen to measure fat, iron, fibro-inflammation in the liver. Baseline metabolic measurements will include clinical laboratory tests, anthropometrics, body composition, resting energy expenditure, and comprehensive metabolomic profiling. Medical history, physical activity, dietary intake, and sleep quality will also be documented.

Study subjects in with MASLD will be randomized to consume either 9g/day of glycine capsules or placebo capsules for the next 26 ± 4 weeks. Subjects MASLD will be reviewed at 12 ± 4 weeks following the initiation of glycine or placebo to monitor compliance and adverse events.

The final study visit (for subjects with MASLD) will be scheduled at 26 ± 4 weeks after initiation of glycine or placebo. The study subjects will undergo metabolic measurements similar to those performed during the baseline visit.

Вмешательства

  • Пищевая добавка Glycine
    9g/day of glycine in capsules
  • Пищевая добавка Placebo
    Microcrystalline cellulose in identifically-looking capsules

Первичные конечные точки

  • Changes in hepatic Magnetic Resonance Imaging-Proton Density Fat Fraction and concentrations of acylglycines, glutathione, cytokines, oxidative stress markers, and 1-carbon cycle metabolites from baseline to 26 weeks [Срок оценки: From the initiation to end of the treatment at 26 weeks]
  • Differences in concentrations of acylglycines, glutathione, cytokines, oxidative stress markers, and 1-carbon cycle metabolites between subjects with MASLD and controls [Срок оценки: From enrollment to the completion of baseline metabolic assessment (within 8 weeks)]

Критерии участия

Критерии включения

All subjects:

  • Age 21-70 years
  • Ability to provide informed consent.

MASLD group:

  • Hepatic steatosis on MRI
  • BMI of 25-50 kg/m2

Controls:

  • Absence of hepatic steatosis on MRI
  • BMI of 18.5-24.9 kg/m2
  • No chronic disease
  • No long-term medications

Критерии исключения

  • Uncontrolled diabetes (HbA1c > 8%)
  • Type 1 Diabetes Mellitus
  • Clinically significant anemia (Haemoglobin < 10 g/dL)
  • Chronic liver disorders (except MASLD) such as Hepatitis B, Hepatitis C, Wilson's disease, hemochromatosis, autoimmune hepatitis, chronic cholestatic disorders, and liver cirrhosis
  • Drugs that may induce hepatic steatosis, such as methotrexate, amiodarone, tamoxifen, or Systemic steroid usage (eg. prednisolone, hydrocortisone, cortisone, dexamethasone)
  • Glomerular filtration rate (GFR < 30 ml/min)
  • Serum alanine transaminase (ALT) > 3x upper limit of normal (ULN)
  • Serum aspartate transaminase (AST) > 3x ULN
  • Liver cirrhosis
  • Significant alcohol consumption (> 20g/day for women and >30g/day for men)
  • Receiving weight loss medications or GLP-1 receptor agonists
  • Pregnancy
  • Uncontrolled thyroid disease
  • Previous bariatric surgery
  • Weight loss > 5% in the past 1 month
  • Metallic implants (including incompatible pacemakers, AICD, metallic heart valves) or other contraindications to MRI
  • Claustrophobia
  • Any factors likely to limit adherence to study protocol (e.g., dementia; alcohol or substance abuse; history of unreliability in medication taking or appointment keeping; significant concerns about participation in the study from spouse, significant other, or family members)

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
Четверное слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07285135 · 2025-1240 · CSAINV25jan-0007

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗