跳至主要内容
临床试验/NCT05995002
NCT05995002已完成不适用

Effects of Increasing Anthocyanin Intake on Cardiometabolic Biomarkers in Patients With Coronary Artery Disease

Shahid Beheshti University2 个研究点 分布在 2 个国家目标入组 62 人开始时间: 2023年8月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
2
主要终点
Plasma inflammatory factors concentration

研究概览

简要总结

Flavonoids are one of the main groups of polyphenols. Anthocyanins, which are a subgroup of the flavonoid family, are found in a number of fruits and some vegetables. In epidemiological studies, high dietary intake of polyphenols has been associated with improvement of some cardiometabolic risk factors in high-risk individuals. Furthermore, in controlled studies, consumption of polyphenol-rich food sources or anthocyanin extract supplementation has improved some cardiometabolic factors. In the present study, the effect of diet enriched with anthocyanin-rich food sources on cardiometabolic factors will be studied in coronary artery disease patients.

详细描述

This study is an unblinded randomized controlled clinical trial. In this study, among the patients referred to Shahid Modares Hospital (Tehran, IRAN), those who are willing to participate and have inclusion criteria will be recruited. Inclusion criteria are coronary heart disease with recent coronary angiography, age range of 30-75 years. Exclusion criteria are end-stage renal disease, patients undergoing chemotherapy or radiotherapy, patients with inflammatory bowel syndrome, patients being treated with glucocorticoid drugs or antibiotics. Patients are randomly assigned to one of two study groups, including the control group and the group consuming food sources rich in anthocyanin in the diet. The duration of the study will be 8 weeks. In the control group, a general recommendation related to a healthy diet such as reducing the intake of saturated fats, sodium, and simple sugars, is provided. In the anthocyanin-rich diet group, the weekly food plan aims to increase the consumption of anthocyanin-rich sources such as berries, black grapes (or currants), cherries, strawberries, pomegranates, and red onions. The patients' drug regimen will not change during the study. Patients are asked not to use over-the-counter herbal medicines and nutritional supplements during the study. At the beginning and end of the study, blood,

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • coronary heart disease with recent coronary angiography

排除标准

  • End-stage renal disease,
  • Patients undergoing chemotherapy or radiotherapy,
  • Patients with inflammatory bowel syndrome
  • Patients being treated with glucocorticoid drugs or antibiotics.

结局指标

主要结局

Plasma inflammatory factors concentration

时间窗: 8 weeks

fasting plasma concentration of C-reactive protein and IL-6

次要结局

  • Plasma concentration of insulin(8 weeks)
  • Plasma levels of lipids and lipoproteins(8 weeks)

研究者

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

Javad Nasrollahzadeh

Associate Professor

Shahid Beheshti University of Medical Sciences

研究点 (2)

Loading locations...

相似试验