LLLT for Reducing Waste Circumference and Weight

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.

Inclusion Criteria:

1. over 18 years of age;

2. body weight of greater than 50 kg (110 pounds);

3. BMI between 25-29.9 kg/m2;

4. able to participate fully in all aspects of the study

5. understood and signed study informed consent

Exclusion Criteria:

1. used weight loss medications or participated in a weight loss program within past 30
days

2. currently taking supplements known to affect weight (garcinia cambogia, etc.)

3. weight fluctuations of 20 pounds or more in the past 6 months

4. implanted device (including pacemaker or lap band) in the targeted area of LLLT

5. known active eating disorder

6. known, active, untreated clinically significant psychiatric condition (alcohol or
substance abuse, psychosis, bipolar disorder, or depression)

7. used an investigational drug within 30 days of study enrollment

8. 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

9. history of any major cardiovascular events

10. current uncontrolled hypertension

11. clinically significant acute or chronic progressive or unstable neurologic, hepatic,
renal, cardiovascular, lymphatic, respiratory, or metabolic disease

12. Prior surgical intervention for body sculpting/weight loss

13. medical, physical, or other contraindications for body sculpting/weight loss

14. any medical condition known to affect weight levels or to cause bloating or swelling

15. diagnosis of, and/or taking medication for, irritable bowel syndrome

16. active infection, wound or other external trauma to the areas to be treated with the
laser

17. known photosensitivity disorder;

18. current active cancer or currently receiving treatment for or within 1 year of cancer
remission