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

NCT07723196 | Not Yet Recruiting

• 1 other identifier: CEPIUG-P13-2025
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)

Keywords

liver function; dietary AGEs; metabolic hepatic steatosis

Outcome Measures

Primary Outcomes (3)

• 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: 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.

  12 weeks

Secondary Outcomes (4)

• Glucose Metabolism: glucose

  12 weeks

• Lipid profile

  12 weeks

• Insulin Resistance

  12 weeks

• Glycated Hemoglobin

  12 weeks

Study Arms (2)

Usual diet group

NO INTERVENTION

Participants assigned to this group will follow their usual diet.

Group with AGE-restricted diet

OTHER

Participants assigned to this group will be given recommendations on how to prepare food.

Other: Recommendations for food preparation

Interventions

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.

Group with AGE-restricted diet

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Guanajuato: lead

Study Sites (1)

Universidad de Guanajuato

Celaya, Guanajuato, 38140, Mexico

Location

Study Officials

• Hilda Lissette López-Lemus, PhD

  Universidad de Guanajuato

  PRINCIPAL INVESTIGATOR

• Ma. Eugenia Garay-Sevilla, PhD

  Universidad de Guanajuato

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hilda Lissette López-Lemus, PhD

CONTACT

+52461 598 59 22; h.lopez@ugto.mx

Ma. Eugenia Garay-Sevilla, PhD

CONTACT

+524777168354; megaray@ugto.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full time teacher

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 23, 2026
• Study Start (Estimated): August 11, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)