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NCT Number: NCT07723196

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Guanajuato

Celaya, Guanajuato, 38140, Mexico

Location contact

María Mercedes Moreno González, PhD

CONTACT

[email protected]

+524615985922 ext. 1651

Montserrat Josefina Olvera Juárez

SUB_INVESTIGATOR

Reyna Rodríguez Mortera, PhD

SUB_INVESTIGATOR

Silvia del Carmen Delgado Sandoval, PhD

SUB_INVESTIGATOR

Vicente Beltrán Campos, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Recommendations for food preparation

Other

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.

Primary outcomes

  1. DIET LOW IN ADVANCED GLYCATION END PRODUCTS

    Time frame: 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.

  2. LIVER FUNCTION

    Time frame: 12 weeks

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

  3. DEGREE OF STEATOSIS

    Time frame: 12 weeks

    The degree of hepatic steatosis will be evaluated by abdominal ultrasound. It will be diagnosed as:

    • - Mild, when increased echogenicity and hepatomegaly are observed.
    • - Moderate, when sound attenuation is present.
    • - Severe, when the portal vein wall and diaphragm are not visualized.

Secondary outcomes

  1. Glucose Metabolism: glucose

    Time frame: 12 weeks

    Will be performed using enzymatic spectrophotometric assays. Measured in mg/dL.

  2. Lipid profile

    Time frame: 12 weeks

    It will be measured using total cholesterol, HDL, LDL, and TG. Each measured in mg/dL.

  3. Insulin Resistance

    Time frame: 12 weeks

    Insulin level will be measured by ELISA (ALPCO) method. The Homeostatic Model Assessment Index (HOMA-IR) will be calculated to determine insulin resistance.

  4. Glycated Hemoglobin

    Time frame: 12 weeks

    Will be performed using enzymatic spectrophotometric assays. Measured in mg/dL.

Study contacts

Contact information is provided by the study sponsor or research team.

Hilda Lissette López-Lemus, PhD

CONTACT

[email protected]

+52461 598 59 22

Ma. Eugenia Garay-Sevilla, PhD

CONTACT

[email protected]

+524777168354 ext. 4641

Sponsors and collaborators

Lead sponsor

Universidad de Guanajuato

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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