Effect of a Low Advanced Glycation End Products Diet of Patients With Type 2 Diabetes Mellitus

December 11, 2025 updated by: ANTONIO DE PADUA MANSUR, InCor Heart Institute

Effect of a Low Advanced Glycation End Products Diet Blood Biomarkers of Patients With Type 2 Diabetes Mellitus: Randomized Controlled Trial.

The present study showed that a reduction of approximately 56% in CML consumption promoted a 30% reduction in this blood biomarker. This effect was associated with increased fiber intake and reduced consumption of polyunsaturated fatty acids, trans fatty acids, and cholesterol, in addition to a positive linear correlation with lipid peroxidation, body water, and dPFGAs. This represents a potential benefit, given that these factors favor insulin resistance (IR) and vascular endothelial injury, and consequently, the processes of diabetes and atherosclerosis. Thus, reducing the daily consumption of CML in the diet, combined with preparing foods at lower temperatures, constitutes a potentially protective nutritional intervention in the context of diabetes and, especially, vascular health, with a plausible impact on the prevention of cardiometabolic complications. It is worth noting that future research for analyses of total PFGAs, specific PFGAs such as pyrraline and pentosidine, and with dPFGAs, and/or studies involving a table of dietary PFGA composition with foods of Brazilian origin are necessary due to their importance in the public health context in Brazil. Furthermore, the need for long-term studies on restricting PFGA consumption is highlighted.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil, 05403- 900
        • Servico de Prevencao, Cardiopatia na Mulher e Reabilitacao Cardiovascular, Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: Men and women, aged between 55 and 65 years, diagnosed with T2DM, CAD, and overweight or obesity were included.

-

Exclusion Criteria:

  • Patients with the following diagnoses were excluded: insulin-dependent diabetes mellitus, renal insufficiency, hepatic insufficiency, eating disorders such as binge eating, depression, and/or anxiety. In addition, patients who were eutrophic, with a body mass index (BMI) were excluded. Smokers, patients who consumed alcoholic beverages, used nutritional supplements, or had a plant-based dietary pattern were also excluded. Likewise, patients who were participating in other research protocols or who did not complete and sign the informed consent form (ICF) were excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
Other: Control
Patients on their usual diet
Active Comparator: Intervention group
Other: a low-CML diet
Patients were instructed to boil or cook their food, and to avoid frying, grilling, and roasting. The assessment of CML content, as well as adherence to the dietary intervention, was based on the average of the 24-Hour Recalls (R24H) and was calculated based on the previous study conducted by Uribarri and collaborators, who evaluated 549 foods, with results published in 2010. The authors estimated that 1 AGE equals 1,000 KU (kilo-units). Considering that the study was conducted with an American population, certain regional foods were not found in the table; therefore, foods with similar composition were used to quantify CML.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the effect of the low-CML diet on the percentage reduction of serum CML in patients with T2DM.
Time Frame: Right after the blood collection
Quantification of serum CML was performed using the OxiSelectTM Nε-(carboxymethyl) lysine Competitive ELISA kit (Cell Biolabs®), following the manufacturer's instructions.
Right after the blood collection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the effect of CML reduction on body composition, through anthropometric and bioimpedance measurements.
Time Frame: 30 minutes, during the consultation on the first evaluation day and on Day 15 afterward.
For the anthropometric assessment, the following variables were used: weight, height, BMI, waist and abdomen circumference. BMI, waist-to-height ratio (WHtR), and abdominal circumference were assessed according to the World Health Organization (WHO). All circumferences were performed in triplicate. Determination of body composition was performed by bioelectrical impedance analysis (BIA) using the Tanita Corporation® (BC601 2018-2020, Maeno-cho Itabashi ku, Tokyo, Japan).
30 minutes, during the consultation on the first evaluation day and on Day 15 afterward.
To evaluate the influence of reduced CML levels on the serum concentrations of glucose, insulin, triglycerides, HDL (High-Density Lipoprotein), and LDL (Low-Density Lipoprotein).
Time Frame: Right after the blood collection

The dosages of glucose,, LDL, HDL, and triglycerides were performed using a colorimetric assay on an automated Alinity C analyzer (Abbott, TX, USA), utilizing specific kits.

Insulin dosages were performed by chemiluminescence on an automated Alinity I analyzer (Abbott), utilizing specific kits.
Right after the blood collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InCor Heart Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2022

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

December 11, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Actual)

December 26, 2025

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 52932821.9.0000.0068

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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