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

NCT07303842 | Completed

• 1 other identifier: 52932821.9.0000.0068
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes; Coronary Artery Disease (CAD)

Keywords

Carboxymethyllysine; Advanced glycation end products in food; Type 2 diabetes mellitus; Coronary artery disease; Randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• To evaluate the effect of the low-CML diet on the percentage reduction of serum CML in patients with T2DM.

  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 Outcomes (2)

• To evaluate the effect of CML reduction on body composition, through anthropometric and bioimpedance measurements.

  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).

  Right after the blood collection

Study Arms (2)

Control group

PLACEBO COMPARATOR

Other: Control

Intervention group

ACTIVE COMPARATOR

Other: a low-CML diet

Interventions

Control OTHER

Patients on their usual diet

Control group

a low-CML diet OTHER

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.

Intervention group

Eligibility Criteria

• Age: 55 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• InCor Heart Institute: lead

Study Sites (1)

Servico de Prevencao, Cardiopatia na Mulher e Reabilitacao Cardiovascular, Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP,

São Paulo, São Paulo, 05403- 900, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 26, 2025
• Study Start: March 8, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

BR (1)