LLLT for Reducing Waste Circumference and Weight

Study Overview
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Brief Summary
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The purpose of this research is to gather preliminary information on the effectiveness of Low Level Laser Therapy (LLLT) in helping people reduce their weight gain in the central body region.

Detailed Description
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This will be an open label clinical trial with all study participants receiving LLLT. Preliminary data will be collected on the efficacy of LLLT based on varying frequency of treatments. The focus of this study on 60 overweight adults with a BMI of 25 to 29.9, and assess changes in weight and waist circumference at end of treatment for group 1 (week 4) and group 2 (week 6) and group 3 (week 12). Participants will be randomized to receive LLLT treatments either 3 times a week; 2 times a week; or once a week.

Official Title
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A Feasibility Study Addressing the Frequency of Low Level Laser Therapy for Reducing Central Adiposity and Weight in Overweight Individuals

Conditions
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Weight Loss

Intervention / Treatment
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* Device: 3 Low-Level Laser Therapy Treatments Weekly
* Device: 2 Low-Level Laser Therapy Treatments Weekly
* Device: 1 Low-Level Laser Therapy Treatment Weekly


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over 18 years of age; body weight of greater than 50 kg (110 pounds); BMI between 25-29.9 kg/m2; able to participate fully in all aspects of the study understood and signed study informed consent Exclusion Criteria: used weight loss medications or participated in a weight loss program within past 30 days currently taking supplements known to affect weight (garcinia cambogia, etc.) weight fluctuations of 20 pounds or more in the past 6 months implanted device (including pacemaker or lap band) in the targeted area of LLLT known active eating disorder known, active, untreated clinically significant psychiatric condition (alcohol or substance abuse, psychosis, bipolar disorder, or depression) used an investigational drug within 30 days of study enrollment currently pregnant or lactating, or are of child-bearing potential or are likely to become pregnant during the medication phase and unwilling to use a reliable form of contraception history of any major cardiovascular events current uncontrolled hypertension clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, lymphatic, respiratory, or metabolic disease Prior surgical intervention for body sculpting/weight loss medical, physical, or other contraindications for body sculpting/weight loss any medical condition known to affect weight levels or to cause bloating or swelling diagnosis of, and/or taking medication for, irritable bowel syndrome active infection, wound or other external trauma to the areas to be treated with the laser known photosensitivity disorder; current active cancer or currently receiving treatment for or within 1 year of cancer remission

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laser for 4 weeks<br>3 Low-Level Laser Therapy Treatments Weekly | Device: 3 Low-Level Laser Therapy Treatments Weekly<br>* Receives 12 LLLT treatment - at a frequency of 3 times per week for 4 weeks<br>|
| Active Comparator: Laser for 6 weeks<br>2 Low-Level Laser Therapy Treatments Weekly | Device: 2 Low-Level Laser Therapy Treatments Weekly<br>* Receives 12 LLLT treatments - at a frequency of 2 times per week for 6 weeks<br>|
| Active Comparator: Laser for 12 weeks<br>1 Low-Level Laser Therapy Treatment Weekly | Device: 1 Low-Level Laser Therapy Treatment Weekly<br>* Receive 12 LLLT treatments - at a frequency of once per week for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight | Comparison of weight change from baseline between arms | baseline and 4 weeks | 
| Change in Waist Circumference | Comparison of waist circumference change from baseline between arms | baseline and 4 weeks |