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临床试验/NCT07303842
NCT07303842已完成不适用

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

InCor Heart Institute2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年3月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
2
主要终点
To evaluate the effect of the low-CML diet on the percentage reduction of serum CML in patients with T2DM.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
55 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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)

研究者

发起方
InCor Heart Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

ANTONIO DE PADUA MANSUR

Dr

InCor Heart Institute

研究点 (2)

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