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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.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07723196
Enrollment
48
Registered
2026-07-23
Start date
2026-08-11
Completion date
2026-12-15
Last updated
2026-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)

Keywords

liver function, dietary AGEs, metabolic hepatic steatosis

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.

Interventions

OTHERRecommendations 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.

Sponsors

Universidad de Guanajuato
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
DIET LOW IN ADVANCED GLYCATION END PRODUCTS12 weeksTo 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 FUNCTION12 weeksThrough liver function tests (ALT, AST, ALP, and GGT). Each measured in mg/dL.
DEGREE OF STEATOSIS12 weeksThe 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.

Secondary

MeasureTime frameDescription
Glucose Metabolism: glucose12 weeksWill be performed using enzymatic spectrophotometric assays. Measured in mg/dL.
Lipid profile12 weeksIt will be measured using total cholesterol, HDL, LDL, and TG. Each measured in mg/dL.
Insulin Resistance12 weeksInsulin level will be measured by ELISA (ALPCO) method. The Homeostatic Model Assessment Index (HOMA-IR) will be calculated to determine insulin resistance.
Glycated Hemoglobin12 weeksWill be performed using enzymatic spectrophotometric assays. Measured in mg/dL.

Countries

Mexico

Contacts

CONTACTHilda Lissette López-Lemus, PhD
h.lopez@ugto.mx+52461 598 59 22
CONTACTMa. Eugenia Garay-Sevilla, PhD
megaray@ugto.mx+524777168354
PRINCIPAL_INVESTIGATORHilda Lissette López-Lemus, PhD

Universidad de Guanajuato

PRINCIPAL_INVESTIGATORMa. Eugenia Garay-Sevilla, PhD

Universidad de Guanajuato

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 24, 2026