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临床试验/NCT07723196
NCT07723196尚未招募不适用

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

Universidad de Guanajuato1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2026年8月11日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
48
试验地点
1
主要终点
DIET LOW IN ADVANCED GLYCATION END PRODUCTS

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

DIET LOW IN ADVANCED GLYCATION END PRODUCTS

时间窗: 12 weeks

To follow the AGE-restricted diet, only the method of food preparation will be specified, as reported by Uribarri et al. and Luévano et al. Measurement of AGEs in KU.

LIVER FUNCTION

时间窗: 12 weeks

Through liver function tests (ALT, AST, ALP, and GGT). Each measured in mg/dL.

DEGREE OF STEATOSIS

时间窗: 12 weeks

The degree of hepatic steatosis will be evaluated by abdominal ultrasound. It will be diagnosed as: 1. \- Mild, when increased echogenicity and hepatomegaly are observed. 2. \- Moderate, when sound attenuation is present. 3. \- Severe, when the portal vein wall and diaphragm are not visualized.

次要结局

  • Glucose Metabolism: glucose(12 weeks)
  • Lipid profile(12 weeks)
  • Insulin Resistance(12 weeks)
  • Glycated Hemoglobin(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hilda Lissette López Lemus

Full time teacher

Universidad de Guanajuato

研究点 (1)

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