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临床试验/NCT01886482
NCT01886482已完成3 期

Effect of High Protein Diet on Cardiovascular Diseases Risk Factors Among Overweight and Obese Children

Isfahan 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: 2011年9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
50
试验地点
1
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 among overweight and obese children.

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, the investigators aimed to determine the effects of HP diet on CVD risk factors among overweight and obese children.

Design: In this randomized controlled trial, the investigators recruited 50 overweight and obese women, aged 6-11years into HP or control energy restricted diets for 10 weeks (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, 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
6 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • BMI > 85th age of 6-11 years
  • no history of chronic diseases
  • no taken medications

排除标准

  • do not prescribe their diet
  • mental retardation

结局指标

主要结局

the amount of weight reduction in two dietary groups

时间窗: 10 weeks

weight reduction (kg)

次要结局

  • LDL (mg/ml)(10 weeks)
  • HDL (mg/ml)(10 weeks)
  • fasting blood glucose(10 weeks)
  • total cholesterol (mg/dl)(10 weeks)
  • blood pressure(10 weeks)

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

研究点 (1)

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