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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorUniversidad de Guanajuato

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Recommendations for food preparation

    Other intervention

    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.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Usual diet groupNo intervention 0 interventions
Group B: Group with AGE-restricted dietOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 weeks
2

LIVER FUNCTION

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

Time frame
12 weeks
3

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.

Time frame
12 weeks

Secondary outcomes

1

Glucose Metabolism: glucose

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

Time frame
12 weeks
2

Lipid profile

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

Time frame
12 weeks
3

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.

Time frame
12 weeks
4

Glycated Hemoglobin

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

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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