跳至主要内容
临床试验/NCT01763528
NCT01763528已完成3 期

High Protein Diet , CRP and CVD Risk Factors

Isfahan University of Medical Sciences0 个研究点目标入组 63 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
63
主要终点
the amount of weight reduction in two dietary groups

研究概览

简要总结

The investigators aimed to determine the effects of HP diet on CVD risk factors and hs-CRP among overweight and obese women.

详细描述

Background: Studies regarding the effects of high protein (HP) diet on cardiovascular (CVD) risk factors have reported contradictory results.

Objective

In present study, we aimed to determine the effects of HP diet on CVD risk factors and hs-CRP among overweight and obese women.

Design: In this randomized controlled trial, we recruited 60 overweight and obese women, aged 20-65 years into HP or control energy restricted diets for three months (protein, carbohydrate, fat: 25%, 45%, 30% vs. 15%, 55%, 30%, respectively). Total protein amount, divided to animal and plant sources in 50%-50% and animal sources distributed (half/half) between meats and dairy products. Fasting blood samples, hs-CRP, lipid profile, systolic and diastolic blood pressure and anthropometric measurements were measured based on the standard guidelines.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

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

入选标准

  • women aged between 20-65 years
  • BMI > 25 kg/m2
  • were no smoker
  • no history of renal, liver, metabolic diseases or type 1 or 2 diabetes

排除标准

  • had gastrointestinal, respiratory, cardiovascular, metabolic, liver and renal -diseases
  • had macroalbuminuria
  • were pregnancy or lactating

结局指标

主要结局

the amount of weight reduction in two dietary groups

时间窗: 3 months

weight reduction (kg)

次要结局

  • LDL-C (mg/dl(3 months)
  • HDL-C (mg/dl)(3 months)
  • total cholesterol (mg/dl)(3 months)
  • fasting blood glucose(mg/dl)(3 months)
  • blood pressure (mmHg)(3 months)
  • C-reactive protein (mc/dl)(3 months)

研究者

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

Leila Azadbakht

Isfahan University of Medical Sciences,

Isfahan University of Medical Sciences

相似试验