Clinical trial NCT05083442: Low-level Laser and Lifestyle Modifications
Official title: A Feasibility Study Addressing the Adjunct Use of Low-Level Laser to Mayo Lifestyle Modification Education and Wellness Coaching for Reducing Central Adiposity and Fat Mass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Weight Loss
Keywords: BMI
Fat Mass
Weight Loss
Body Circumference Reduction
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Erchonia Corporation
First posted: 2021-10-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial where subjects are placed into 2 different study arms. Subjects randomized to 2 groups that either receive Low Level Laser therapy with lifestyle modifications or Sham (placebo) with Lifestyle Modifications.
Primary purpose: TREATMENT

Brief summary: 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

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in Fat Mass From Baseline to 6 Weeks
timeFrame: 6 weeks
measure: Change in Waist Circumference From Baseline to 6 Weeks
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Professor of Medicine, College of Medicine
name: Ivana T Croghan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Ryan T Hurt, MD, PhD
role: STUDY_DIRECTOR
References: