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临床试验/NCT02573961
NCT02573961撤回不适用

Laser Acupuncture Versus High Protein/Low Carbohydrate Diet on Endothelial Markers in Obese Females. A Randomized Controlled Trial

National Research Centre, Egypt1 个研究点 分布在 1 个国家开始时间: 2015年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
weight loss

研究概览

简要总结

The purpose of this study is to compare the effects of laser acupuncture and high protein low carbohydrate diet on the treatment of obesity and lowering of endothelial markers.

详细描述

Sixty females above 20 years of age with a body mass index (BMI) of over 30 kg/m2 will be divided into three groups (20 in each): two experimental groups (laser; high protein low carbohydrate diet) and control. Each subject will receive the treatment relevant to their group, in addition to obtaining 3 days dietary recalls and measurements including BMI, serum insulin and endothelial markers. Laser and control group will receive 24 activated or sham laser acupuncture treatments. High protein low carbohydrate group will be instructed to take a tailored high protein/low carbohydrate diet.

研究设计

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

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •obese females of BMI more than 30 kg/m2, and
  • •of age range from 20 to 50 years.

排除标准

  • •medical history of chronic diseases,
  • •pregnancy,
  • •photosensitivity reactions to laser treatment,
  • •a pacemaker,
  • •medications known to affect one's weight up to 1 month in advance, or
  • •are unwilling to comply with the study protocol.

研究组 & 干预措施

laser

Active Comparator

Subjects will receive 24 activated laser acupuncture group treatments. The laser will be applied for 10 seconds to each of the selected acupuncture points. In addition they will be instructed to take a tailored low caloric diet

干预措施: Laser acupuncture (Device)

laser

Active Comparator

Subjects will receive 24 activated laser acupuncture group treatments. The laser will be applied for 10 seconds to each of the selected acupuncture points. In addition they will be instructed to take a tailored low caloric diet

干预措施: low caloric diet (Behavioral)

high protein low carbohydrate diet

Active Comparator

Subjects will be instructed to take a tailored high protein/low carbohydrate/low caloric diet.

干预措施: high protein low carbohydrate diet (Behavioral)

control

Sham Comparator

Subjects in the control group will undergo sham laser acupuncture treatment with no laser power output. In addition they will be instructed to take a tailored low caloric diet .

干预措施: Laser acupuncture (Device)

control

Sham Comparator

Subjects in the control group will undergo sham laser acupuncture treatment with no laser power output. In addition they will be instructed to take a tailored low caloric diet .

干预措施: low caloric diet (Behavioral)

结局指标

主要结局

weight loss

时间窗: 8 weeks

次要结局

  • decrease cardiovascular risks(8 weeks)

研究者

发起方
National Research Centre, Egypt
申办方类型
Other
责任方
Sponsor

研究点 (1)

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