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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
• Intervention / Treatment: Other: Recommendations for food preparation

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hilda Lissette López-Lemus, PhD; Phone Number: +52461 598 59 22; Email: h.lopez@ugto.mx
• Study Contact Backup: Name: Ma. Eugenia Garay-Sevilla, PhD; Phone Number: 4641 +524777168354; Email: megaray@ugto.mx

Study Locations

• Mexico
  • Guanajuato
    • Celaya, Guanajuato, Mexico, 38140
      • Universidad de Guanajuato
      • Contact: María Mercedes Moreno González, PhD; Phone Number: 1651 +524615985922; Email: deo_celaya@ugto.mx
      • Sub-Investigator: Vicente Beltrán Campos, PhD
      • Sub-Investigator: Silvia del Carmen Delgado Sandoval, PhD
      • Sub-Investigator: Montserrat Josefina Olvera Juárez
      • Sub-Investigator: Reyna Rodríguez Mortera, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual diet group; Participants assigned to this group will follow their usual diet.
Other: Group with AGE-restricted diet; Participants assigned to this group will be given recommendations on how to prepare food.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DIET LOW IN ADVANCED GLYCATION END PRODUCTS	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.	12 weeks
LIVER FUNCTION	Through liver function tests (ALT, AST, ALP, and GGT). Each measured in mg/dL.	12 weeks
DEGREE OF STEATOSIS	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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose Metabolism: glucose	Will be performed using enzymatic spectrophotometric assays. Measured in mg/dL.	12 weeks
Lipid profile	It will be measured using total cholesterol, HDL, LDL, and TG. Each measured in mg/dL.	12 weeks
Insulin Resistance	Insulin level will be measured by ELISA (ALPCO) method. The Homeostatic Model Assessment Index (HOMA-IR) will be calculated to determine insulin resistance.	12 weeks
Glycated Hemoglobin	Will be performed using enzymatic spectrophotometric assays. Measured in mg/dL.	12 weeks

Collaborators and Investigators

• Sponsor: Universidad de Guanajuato
• Investigators: Principal Investigator: Ma. Eugenia Garay-Sevilla, PhD, Universidad de Guanajuato; Principal Investigator: Hilda Lissette López-Lemus, PhD, Universidad de Guanajuato

Study record dates

Study Major Dates

• Study Start (Estimated): August 11, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: July 10, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: liver function; dietary AGEs; metabolic hepatic steatosis
• Other Study ID Numbers: CEPIUG-P13-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: At the request of the researcher.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No