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

20. juli 2026 opdateret af: Hilda Lissette López Lemus, Universidad de Guanajuato

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

48

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Hilda Lissette López-Lemus, PhD
  • Telefonnummer: +52461 598 59 22
  • E-mail: h.lopez@ugto.mx

Undersøgelse Kontakt Backup

  • Navn: Ma. Eugenia Garay-Sevilla, PhD
  • Telefonnummer: 4641 +524777168354
  • E-mail: megaray@ugto.mx

Studiesteder

  • Mexico
    • Guanajuato
      • Celaya, Guanajuato, Mexico, 38140
        • Universidad de Guanajuato
        • Kontakt:
          • María Mercedes Moreno González, PhD
          • Telefonnummer: 1651 +524615985922
          • E-mail: deo_celaya@ugto.mx
        • Underforsker:
          • Vicente Beltrán Campos, PhD
        • Underforsker:
          • Silvia del Carmen Delgado Sandoval, PhD
        • Underforsker:
          • Montserrat Josefina Olvera Juárez
        • Underforsker:
          • Reyna Rodríguez Mortera, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Usual diet group
Participants assigned to this group will follow their usual diet.
Andet: Group with AGE-restricted diet
Participants assigned to this group will be given recommendations on how to prepare food.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
DIET LOW IN ADVANCED GLYCATION END PRODUCTS
Tidsramme: 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.
12 weeks
LIVER FUNCTION
Tidsramme: 12 weeks
Through liver function tests (ALT, AST, ALP, and GGT). Each measured in mg/dL.
12 weeks
DEGREE OF STEATOSIS
Tidsramme: 12 weeks

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Glucose Metabolism: glucose
Tidsramme: 12 weeks
Will be performed using enzymatic spectrophotometric assays. Measured in mg/dL.
12 weeks
Lipid profile
Tidsramme: 12 weeks
It will be measured using total cholesterol, HDL, LDL, and TG. Each measured in mg/dL.
12 weeks
Insulin Resistance
Tidsramme: 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.
12 weeks
Glycated Hemoglobin
Tidsramme: 12 weeks
Will be performed using enzymatic spectrophotometric assays. Measured in mg/dL.
12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universidad de Guanajuato

Efterforskere

  • Ledende efterforsker: Ma. Eugenia Garay-Sevilla, PhD, Universidad de Guanajuato
  • Ledende efterforsker: Hilda Lissette López-Lemus, PhD, Universidad de Guanajuato

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

11. august 2026

Primær færdiggørelse (Anslået)

15. december 2026

Studieafslutning (Anslået)

15. december 2026

Datoer for studieregistrering

Først indsendt

10. juli 2026

Først indsendt, der opfyldte QC-kriterier

20. juli 2026

Først opslået (Faktiske)

23. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • CEPIUG-P13-2025

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

At the request of the researcher.

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Kliniske forsøg med MASLD (Metabolisk Dysfunktions-Associeret Steatotisk Leversygdom)

Kliniske forsøg med Recommendations for food preparation

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