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临床试验/NCT03318913
NCT03318913已完成不适用

Effect of Acute Fish Protein Hydrolysates Ingestion on Vascular Function of the Type 2 Diabetes Subjects

Universidade Federal do Rio de Janeiro1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2017年10月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
High performance liquid chromatography

研究概览

简要总结

Type 2 diabetes mellitus (T2DM) is a chronic metabolic disease of abnormal carbohydrate metabolism which is related with high morbidity and mortality rates caused by its complications. One of the major diabetes-related arterial phenotypes thought to be responsible for development of cardiovascular disease is endothelial dysfunction. Nitric oxide (NO) is a potent molecule derived of endothelium, which plays key role in control of vascular tone. In T2DM present endothelial dysfunction due to reduced NO bioavailability. Fish protein hydrolysates (FPH) have been showed to present antioxidant peptides (and high value of ACE inhibition activity. Therefore, the present study aimed to examine whether single dose of FPH ingestion would reversal macro- and microvascular endothelial dysfunction in T2DM.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

Double blind

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Type 2 diabetes mellitus

排除标准

  • •History of symptomatic coronary artery disease;
  • •Stroke or other known atherosclerotic disease;
  • •HIV positive;
  • •Alcohol or drug abuse within the past 6 months previous the visit 1;
  • •use any antioxidant supplementation

研究组 & 干预措施

Health control

No Intervention

Health young subjects free of diabetes mellitus and nutritional intervention

DM Placebo

Placebo Comparator

Sucralose

干预措施: Placebo (Other)

DM FHP

Active Comparator

Fish protein hydrolysates

干预措施: Fish protein hydrolysates (Other)

结局指标

主要结局

High performance liquid chromatography

时间窗: 75 min after nutritional intervention

serum amino acids

Flow-mediated dilation

时间窗: 60 min after nutritional intervention

macrovascular endothelial function

Near infrared spectroscopy

时间窗: 70 min after nutritional intervention

microvascular endothelial function

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thiago Alvares

D.sc

Universidade Federal do Rio de Janeiro

研究点 (1)

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