Effect of High Protein Diet on Hepatic Steatosis in Patients With MAFLD
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: High protein diet, Normal Protein diet.
- Кому может быть актуально
- Состояния в реестре: Metabolic Dysfunction Associated Fatty Liver Disease. Базовые параметры: 18 лет — 60 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
- Индия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Effect of High Protein Diet on Hepatic Steatosis, Inflammation and Mitochondrial Bioenergetics in Patients With MAFLD : A Randomized Controlled Trial
Обзор
MAFLD is a growing problem in India. Its pathophysiology is complex, but focused on abnormal substrate handling due to mitochondrial dysfunction reflecting as metabolic inflexibility. Nutrition is the cornerstone of management. The ideal macronutrient distribution within a hypocaloric diet is not known yet. Evidence from experimental and a few human studies in obese, highlight the role of dietary proteins, independent of calorie restriction, in reducing hepatic steatosis by improving the cellular and systemic bioenergetics.
Подробное описание
Novelty: First study to assess the effect of high protein diet (HPD) in comparison to a standard protein diet (SPD) within a calorie restricted diet, on both the cellular and systemic bioenergetics in patients with MAFLD.
Objectives: Aims to see the effect of HPD on hepatic steatosis, cellular and systemic bioenergetics, along with metabolic parameters in patients with MAFLD.
Method: In this RCT, patients with MAFLD (n=140) with or without MS, would be randomized into HPD or SPD groups (i.e. 70 in each group), and parameters like hepatic steatosis (CAP by Transient elastography (FibroScan), cellular bioenergetics by oxygen consumption rate (OCR) and extracellular acidification rate (ECAR) as measured using Seahorse Analyzer, and Indirect Calorimetry will be used to assess the fasting and postglucose challenge (Oral glucose tolerance test) REE and RQ. DEXA scan would be used to assess body composition apart from routine blood tests to assess features of Metabolic syndrome. The serum levels of GLP1, CKK, Ghrelin, FGF21, Adipokines like leptin and adiponectin, NADH/NAD ratio, insulin and glucagon would be measured.
Outcome: A HPD is expected to improve hepatic steatosis, blunted fuel switching (RQ) and cellular bioenergetics (OCR) along with metabolic parameters in patients with MAFLD.
Вмешательства
- Пищевая добавка High protein diet
High protein diet - Пищевая добавка Normal Protein diet
Normal protein diet
Первичные конечные точки
- Assessment of Hepatic steatosis. [Срок оценки: 3 months]
Вторичные конечные точки (12)
- Assessment of cellular bioenergetics would be done. [Срок оценки: 3 months]
- Assessment of cellular bioenergetics would be done. [Срок оценки: 3 months]
- Assessment of systemic bioenergetics would be done. [Срок оценки: 3 months]
- Assessment of metabolic markers at baseline and follow up. [Срок оценки: 3 months]
- Assessment of muscle mass. [Срок оценки: 3 months]
- Assessment of serum levels of FGF21(in ng/ml) and leptin(in ng/ml). [Срок оценки: 3 months]
- Assessment of serum levels of adiponectin(in μg/mL). [Срок оценки: 3 months]
- Assessment of serum levels of insulin(in μU/mL) [Срок оценки: 3 months]
- Assessment of serum levels of glucagon(in pg/mL). [Срок оценки: 3 months]
- Assessment of serum levels of glucagon like peptide(GLP-1) (in pmol/L) [Срок оценки: 3 months]
- Assessment of serum levels of ghrelin (in fmol/ml). [Срок оценки: 3 months]
- Assessment of serum levels of cholecystokinin (in pmol/liter). [Срок оценки: 3 months]
Критерии участия
Критерии включения
- Newly diagnosed treatment naïve consenting adults with MAFLD (controlled attenuation parameter; CAP >250, BMI>23 and/or DM) Age 18-65 years
Критерии исключения
- • Lean (BMI <23) patients
- Age <18 and >65 years
- Individuals who had been hospitalized with complications of Diabetes mellitus, Chronic Kidney disease, Hypertension in the previous 6 months
- Patients with viral hepatitis
- Patients with significant alcohol consumption (regular consumption of > 10g per day for females and > 20g/d in males),
- Patients having chronic inflammatory bowel disease or any chronic and autoimmune diseases will be excluded
- Pregnant \& lactating women
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Индия · 1 центр
- Institute of Liver and Biliary Sciences — Delhi
Идентификаторы
NCT: NCT06749704 · ILBS-MAFLD-01