Effect of a Low AGE Diet on Liver Function in Adults With Fatty Liver.

Официальное название

Effect of a Diet Low in Advanced Glycation End Products on Liver Function and the Degree of Steatosis in Adults With Metabolic Hepatic Steatosis.

Обзор

Introduction. Advanced glycation end products, known as AGEs, are compounds that form when sugars bind uncontrollably to proteins, fats, or DNA. This occurs naturally in the body, but they also form in food, especially when cooked at high temperatures. Techniques such as grilling, frying, browning, or toasting increase AGE formation in food. Processed foods or those dry-heated above 160 °C often contain many AGEs. When we consume them, about 10% of these AGEs can be absorbed by the body. Among the most studied types of AGEs are CML (N-6-carboxymethyl lysine) and pentosidine; these compounds have been found in the blood and liver of people and animals with metabolic hepatic steatosis (METS), a disease characterized by the accumulation of fat in the liver. When the body doesn't respond well to insulin and there are problems processing fats and sugars, the formation of AGEs is favored, which in turn can damage the liver. AGEs act by binding to receptors called RAGE; this binding activates various signals within cells that promote inflammation. Both RAGE and its soluble form (sRAGE) are important in metabolic syndrome (MetS). The AGE-RAGE interaction can contribute to the accumulation of more fat in the liver and help the disease progress to more severe stages. The aim of this study is to evaluate whether a low-AGE diet improves liver function and reduces the amount of fat in the liver in adults with fatty liver not related to alcohol consumption. Our hypothesis is that implementing a low-AGE diet will improve liver function and decrease the degree of steatosis in adults with fatty liver not related to alcohol consumption. A clinical trial will be conducted comparing two groups. Forty-eight people who consume high amounts of AGEs (more than 8,000 KU) and have fatty liver of any grade will participate. Participants will be randomly assigned to one of two groups: one will follow an AGE-restricted diet, and the other will maintain their usual diet, for 12 weeks. Before and after the study, the following measurements will be recorded: weight, height, waist circumference, hip circumference, abdominal circumference, and blood pressure. Fasting blood samples will also be taken to measure glucose (blood sugar), insulin, triglycerides, total cholesterol, HDL, LDL, AGE levels, glycated hemoglobin (which measures the average blood sugar level), and tests to evaluate liver function.

Вмешательства

• Другое Recommendations for food preparation
  Participants assigned to this group will only be given recommendations on how to prepare food according to what was reported by Uribarri et al. and Luévano et al.

Первичные конечные точки

• DIET LOW IN ADVANCED GLYCATION END PRODUCTS [Срок оценки: 12 weeks]
• LIVER FUNCTION [Срок оценки: 12 weeks]
• DEGREE OF STEATOSIS [Срок оценки: 12 weeks]

Вторичные конечные точки (4)

• Glucose Metabolism: glucose [Срок оценки: 12 weeks]
• Lipid profile [Срок оценки: 12 weeks]
• Insulin Resistance [Срок оценки: 12 weeks]
• Glycated Hemoglobin [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• Men and women between 18 and 55 years old.
• High consumption of essential fatty acids (EFAs) > 8000 KU.
• With metabolic hepatic steatosis (MetHS) of any degree.
• Not currently undergoing nutritional treatment.
• Sedentary lifestyle.
• Denies alcoholism.
• Not taking any medications.
• No other health conditions.

Критерии исключения

• Men and women undergoing treatment for metabolic diseases.
• Men and women with cardiovascular and/or coronary diseases.
• Pregnant women.
• Men and women undergoing hormone therapy.
• Men and women taking dietary supplements.
• Men and women who refuse to sign the informed consent form.
• In cases where space-occupying masses (tumors) are detected during the ultrasound.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Мексика · 1 центр

• Universidad de Guanajuato — Celaya

Идентификаторы

NCT: NCT07723196 · CEPIUG-P13-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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