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临床试验/NCT05492279
NCT05492279已完成不适用

Effect of Sheep Ghee on Lipid Profile and High-sensitivity C-reactive Protein: A Randomized Clinical Trial

Shiraz University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年2月1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
50
试验地点
1
主要终点
HDL cholesterol

研究概览

简要总结

Normal volunteers were randomly received Sheep ghee or sunflower oil, and before and after the study lipid profile and HS-CRP were measured.

详细描述

During outpatient clinic visits, potentially eligible individuals were screened for enrollment according to the inclusion and exclusion criteria.

Patients were randomly allocated into the treatment and control groups via the blocked randomization method.

The control group received a normal diet for eight weeks with 10 g of sunflower oil. In the treatment group, sunflower oil was replaced with 10 g of sheep ghee.

50 patients in each group were enrollment. Patients' information, including demographic data and the serum levels of fasting blood sugar (FBS), LDL, HDL, triglyceride (TG), and hs-CRP, were recorded in datasheets twice: once before treatment with sheep ghee and once eight weeks later.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

random allocation, open label

入排标准

年龄范围
20 Years 至 76 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • healthy adults, seeking outpatient visit at professor kojuri cardiology clinic

排除标准

  • any history of ischemic heart disease (IHD),
  • coronary artery bypass grafting (CABG)
  • percutaneous intervention (PCI)
  • peripheral vascular diseases
  • use of anti-hyperlipidemic agents
  • unwillingness to participate.
  • Need of tight hyperlipidemia control.

结局指标

主要结局

HDL cholesterol

时间窗: 2 months

Serum HDL in mg/dl

LDL cholesterol

时间窗: 2 months

serum LDL level in mg/dl

total cholesterol

时间窗: 2 months

serum total cholesterol in mg/dl

HS-CRP

时间窗: 2 months

HS-CRP level in picogram/dl

次要结局

  • adverse effect(2 months)

研究者

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

Javad Kojuri

professor

Shiraz University of Medical Sciences

研究点 (1)

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