Low-level Laser and Lifestyle Modifications

Inclusion Criteria

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

Exclusion Criteria

• have used weight loss medications or participated in a weight loss program within the past 30 days
• are currently taking medications or supplements known to affect weight, such as insulin or sulfonylurea, prednisone or garcinia cambrogia
• have had weight fluctuations of 5 pounds or more in the past month
• have an implanted device (including pacemaker or lap band) in the targeted area of LLLT
• have a known active eating disorder
• have a known, active, untreated clinically significant psychiatric condition (alcohol or substance abuse, psychosis, bipolar disorder, or depression)
• have used an investigational drug within 30 days of study enrollment
• 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:
• Hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants
• Barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm)
• Intrauterine device (IUD)
• Total hysterectomy or tubal ligation
• Abstinence (no sex)
• 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
• have current uncontrolled hypertension (systolic > 160 mm Hg or diastolic > 95 mm Hg) documented on 2 separate occasions
• 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
• surgical intervention for body sculpting/weight loss, such as liposuction, abdominoplasty, stomach stapling, lap band surgery, etc. within 12 months prior to enrollment
• medical, physical, or other contraindications for body sculpting/weight loss
• any medical condition known to affect weight levels and/or to cause bloating or swelling
• a 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 cancer; or
• have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence