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

U

University of São Paulo (USP)

Status

Completed

Conditions

Type 2 Diabetes
Coronary Artery Disease (CAD)

Treatments

Other: a low-CML diet
Other: Control

Study type

Interventional

Funder types

Other

Identifiers

NCT07303842
52932821.9.0000.0068

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

55 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

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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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

36 participants in 2 patient groups, including a placebo group

Control group
Placebo Comparator group
Treatment:
Other: Control
Intervention group
Active Comparator group
Treatment:
Other: a low-CML diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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