Laser Acupuncture Versus High Protein/Low Carbohydrate Diet on Endothelial Markers in Obese Females

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Device: Laser acupuncture
* Behavioral: high protein low carbohydrate diet
* Behavioral: low caloric diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: obese females of BMI more than 30 kg/m2, and of age range from 20 to 50 years. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: laser<br>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 | Device: Laser acupuncture<br>* GaAlAs semiconductor diode Laser Phototherapy Device<br>Behavioral: low caloric diet<br>* Tailored balanced low caloric diet<br>|
| Active Comparator: high protein low carbohydrate diet<br>Subjects will be instructed to take a tailored high protein/low carbohydrate/low caloric diet. | Behavioral: high protein low carbohydrate diet<br>* A tailored high protein/low carbohydrate/low caloric diet<br>|
| Sham Comparator: control<br>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 . | Device: Laser acupuncture<br>* GaAlAs semiconductor diode Laser Phototherapy Device<br>Behavioral: low caloric diet<br>* Tailored balanced low caloric diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrease cardiovascular risks | endothelial markers , serum insulin and insulin resistance changes from baseline. | 8 weeks |