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临床试验/NCT05423457
NCT05423457已完成不适用

Effectiveness of Vegan Diet and MyPlate Diet (Taiwanese Version) on Lipoproteins, Novel Markers of Cardiovascular Diseases, and Traditional Cardiometabolic Risk Factors

Buddhist Tzu Chi General Hospital1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2017年7月18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
21
试验地点
1
主要终点
lipoprotein particles size

研究概览

简要总结

Systematic inflammation and lipid profiles are two major therapeutic targets for cardiovascular diseases. The effectiveness of vegan diet has been reported (doi: 10.3389/fnut.2022.807810).

Aim:

To compare the effectiveness of a nutritionally balanced vegan diet and a Myplate diet ((Taiwanese version) on systematic inflammation and lipoprotein subclass.

Design: Randomized crossover design

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • Patients with dyslipidemia (at least one of the following)
  • TG ≥ 150 mg/dL
  • TC ≥ 200 mg/dL
  • LDL-c≥ 130 mg/dL,
  • HDL-c < 45 mg/dL for male or < 55 mg/dL for female or receiving statin treatment

排除标准

  • (fulfill one of the following condition):
  • chronic kidney disease
  • history of coronary artery disease
  • ischemic heart disease,
  • heart failure,
  • cancer of any type

结局指标

主要结局

lipoprotein particles size

时间窗: 12 weeks

lipoprotein particles size (nm)

Traditional cadiometabolic risk factors 2

时间窗: 12 weeks

HbA1c(%)

Novel inflammatory markers for cardiovascular disease and Lipoprotein particles concentration

时间窗: 12 weeks

GlycA (umol/L), lipoprotein particles concentration(umol/L)

Lipoprotein particles concentration

时间窗: 12 weeks

lipoprotein particles concentration (nmol/L)

Traditional cadiometabolic risk factors 1

时间窗: 12 weeks

TG(mg/dL), LDL-C(mg/dL), HDL-C(mg/dL), Total cholesterol(mg/dL)

Trimethylamine-N-oxide

时间窗: 12 weeks

TMAO (uM). TMAO is a low molecular weight compound that belongs to the class of amine oxides

Traditional cadiometabolic risk factors 3

时间窗: 12 weeks

HOMA-IR index (Homeostasis Model Assessment-Insulin Resistance index)

次要结局

未报告次要终点

研究者

发起方
Buddhist Tzu Chi General Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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