Low-level Laser and Lifestyle Modifications (LLLT)

Overview

About this study

The study is being done to obtain preliminary evidence regarding the most efficacious approach to LLLT treatments for obtaining fat mass loss and produce reduction in waist circumference.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • 18 years of age or older.
  • BMI of 25–39.9 kg/m^2.
  • 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 the past 30 days.
  • Currently taking medications or supplements known to affect weight, such as prednisone or garcinia cambrogia.
  • 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 LLLT 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).
  • Htory 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.
  • Current uncontrolled hypertension (systolic > 160 mm Hg or diastolic > 95 mm Hg) documented on 2 separate occasions.
  • Clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, lymphatic, respiratory, or metabolic disease (such as diabetes) 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.
  • 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.
  • Have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence.

Eligibility last updated 12/14/21. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ivana Croghan, Ph.D.

Closed for enrollment

Contact information:

Shawn Fokken CCRP

(507) 293-2740

GIMRESEARCHSTUDIES@mayo.edu

More information

Publications

Publications are currently not available