Low-level Laser and Lifestyle Modifications (LLLT)

Mayo Clinic

Status

Completed

Conditions

Weight Loss

Overweight and Obesity

Treatments

Device: Low Level Laser Therapy

Other: Sham (placebo)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05083442

21-008379

Details and patient eligibility

About

The purpose of this research study is to evaluate the effectiveness of Low Level Laser Therapy in combination with Lifestyle Modifications in helping people reduce the extra weight and size in the central body region

Full description

Subjects will undergo Low Level Laser Therapy or Sham (placebo) treatments while incorporating lifestyle modifications through of wellness coaching.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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:
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)
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