Low-level Laser and Lifestyle Modifications (LLLT)

This is an interventional treatment trial for Overweight and Obesity focused on measuring BMI, Fat Mass, Weight Loss, Body Circumference Reduction Read More

Inclusion Criteria:

1. 18 years of age or older
2. have a BMI 25-39.9 kg/m2
3. be able to participate fully in all aspects of the study; and
4. have understood and signed study informed consent

Exclusion Criteria:

1. have used weight loss medications or participated in a weight loss program within the past 30 days
2. are currently taking medications or supplements known to affect weight, such as insulin or sulfonylurea, prednisone or garcinia cambrogia
3. have had weight fluctuations of 5 pounds or more in the past month
4. have an implanted device (including pacemaker or lap band) in the targeted area of LLLT
5. have a known active eating disorder
6. have a known, active, untreated clinically significant psychiatric condition (alcohol or substance abuse, psychosis, bipolar disorder, or depression)
7. have used an investigational drug within 30 days of study enrollment

8. Reports being currently pregnant, lactating, or are of child-bearing potential or are likely to become pregnant during the low-level laser therapy treatment phase and are unwilling to use a reliable form of contraception. Acceptable forms include:

   1. Hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants
   2. Barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm)
   3. Intrauterine device (IUD)
   4. Total hysterectomy or tubal ligation
   5. Abstinence (no sex)
9. have a history of any major cardiovascular events including heart valve disease, ongoing angina, cardiac arrhythmias, congestive heart failure, acute coronary syndrome, stroke, transient ischemic attack, or peripheral vascular disease
10. have current uncontrolled hypertension (systolic > 160 mm Hg or diastolic > 95 mm Hg) documented on 2 separate occasions
11. have clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, lymphatic, respiratory, or metabolic disease (such as uncontrolled diabetes type 2) or active cancer or are within 1 year of cancer remission
12. surgical intervention for body sculpting/weight loss, such as liposuction, abdominoplasty, stomach stapling, lap band surgery, etc. within 12 months prior to enrollment
13. medical, physical, or other contraindications for body sculpting/weight loss
14. any medical condition known to affect weight levels and/or to cause bloating or swelling
15. a 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 cancer; or
19. have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence