MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)NCT07723196
Effect of a Low AGE Diet on Liver Function in Adults With Fatty Liver.
A study testing Recommendations for food preparation in people with MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), run by Universidad de Guanajuato at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
- What is being tested?
- Recommendations for food preparation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteMexico
- Study dates
- 11 Aug 2026to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Universidad de Guanajuato
Celaya, Guanajuato, 38140
María Mercedes Moreno González, PhD, +524615985922 ext. 1651, deo_celaya@ugto.mx
Vicente Beltrán Campos, PhD
About this study
Official title: 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.
Read more
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.
- Being tested
- Recommendations for food preparation
- Keywords
- liver function, dietary AGEs, metabolic hepatic steatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recommendations for food preparationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Recommendations for food preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
LIVER FUNCTION
Through liver function tests (ALT, AST, ALP, and GGT). Each measured in mg/dL.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (4)
Glucose Metabolism: glucose
Will be performed using enzymatic spectrophotometric assays. Measured in mg/dL.
Measured: 12 weeks
Lipid profile
It will be measured using total cholesterol, HDL, LDL, and TG. Each measured in mg/dL.
Measured: 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.
Measured: 12 weeks
Glycated Hemoglobin
Will be performed using enzymatic spectrophotometric assays. Measured in mg/dL.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start11 Aug 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Guanajuato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilda Lissette López Lemus, Universidad de Guanajuato
- Investigators
- Hilda Lissette López-Lemus, PhD, Principal investigator, Universidad de GuanajuatoMa. Eugenia Garay-Sevilla, PhD, Principal investigator, Universidad de Guanajuato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07723196
- Sponsor's protocol ID
- CEPIUG-P13-2025
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At the request of the researcher.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Diet Low in Advanced Glycation End Products on Liver Function and the Degree of Steatosis in Adults With Metabolic Hepatic Steatosis.
- ClinicalTrials.gov ID
- NCT07723196
- Acronym / sponsor ID
- CEPIUG-P13-2025
- Keywords
- liver function, dietary AGEs, metabolic hepatic steatosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Universidad de GuanajuatoUniversity, hospital or other
- Study start
- 11 Aug 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual diet group | No intervention | –Participants assigned to this group will follow their usual diet. |
| Group with AGE-restricted diet | Other | Other: Recommendations for food preparationParticipants assigned to this group will be given recommendations on how to prepare food. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recommendations for food preparationParticipants 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. | Other | Group with AGE-restricted diet |
Primary outcome
DIET LOW IN ADVANCED GLYCATION END PRODUCTS
Time frame: 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.
LIVER FUNCTION
Time frame: 12 weeks
Through liver function tests (ALT, AST, ALP, and GGT). Each measured in mg/dL.
DEGREE OF STEATOSIS
Time frame: 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.
4 secondary outcomes
Glucose Metabolism: glucose
Time frame: 12 weeks
Lipid profile
Time frame: 12 weeks
Insulin Resistance
Time frame: 12 weeks
Glycated Hemoglobin
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No. At the request of the researcher.
Related trials for MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
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Recruiting
Exercise for an Aging Liver (EXALIVER)
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, MASH - Metabolic Dysfunction-Associated Steatohepatitis
RecruitingPhase 3
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A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
RecruitingObservational study
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Metabolic Dysfunction-Associated Steatotic Liver Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hilda Lissette López-Lemus, PhD principal investigator
Universidad de Guanajuato
Ma. Eugenia Garay-Sevilla, PhD principal investigator
Universidad de Guanajuato
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recommendations for food preparation in people with MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), run by Universidad de Guanajuato at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hilda Lissette López-Lemus, PhD (+52461 598 59 22, h.lopez@ugto.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DIET LOW IN ADVANCED GLYCATION END PRODUCTS (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.