LLLT: Low-level Laser and Lifestyle Modifications

• Sponsor: Mayo Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05083442
• Collaborator: Erchonia Corporation (Industry)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 18
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

The purpose of this research study is to evaulate 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

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity; Weight Loss	Device: Low Level Laser Therapy; Other: Sham (placebo)	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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.
• Masking: Single (Participant)
• Masking Description: Randomization will be set up by a statistician through REDCap, the data collection system utilized for the study.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 - LLLT Subject receive Laser treatments and Lifestyle Modifications	Device: Low Level Laser Therapy; Non-surgical cosmetic treatment which can be used by individuals intending to reduce size of the mid-section
Sham Comparator: Group 2 - SHAM Subject receives Sham Laser treatments and Lifestyle Modifications	Other: Sham (placebo); Use of sham (placebo) option

Outcome Measures

Primary Outcome Measures

1. Amount of fat mass loss [6 weeks]

   Compare the amount of fat mass loss at the end of treatments

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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:

9. Hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants

10. Barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm)

11. Intrauterine device (IUD)

12. Total hysterectomy or tubal ligation

13. Abstinence (no sex)

14. 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

15. have current uncontrolled hypertension (systolic > 160 mm Hg or diastolic > 95 mm Hg) documented on 2 separate occasions

16. 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

17. surgical intervention for body sculpting/weight loss, such as liposuction, abdominoplasty, stomach stapling, lap band surgery, etc. within 12 months prior to enrollment

18. medical, physical, or other contraindications for body sculpting/weight loss

19. any medical condition known to affect weight levels and/or to cause bloating or swelling

20. a diagnosis of, and/or taking medication for, irritable bowel syndrome

21. active infection, wound or other external trauma to the areas to be treated with the laser

22. known photosensitivity disorder

23. current active cancer or currently receiving treatment for cancer; or

24. have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic
• Erchonia Corporation

Investigators

• Principal Investigator: Ivana T Croghan, PhD, Professor of Medicine, College of Medicine
• Study Director: Ryan T Hurt, MD, PhD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ivana Croghan, Professor of Medicine, College of Medicine, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT05083442
• Other Study ID Numbers: 21-008379
• First Posted: Oct 19, 2021
• Last Update Posted: Jun 8, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Ivana Croghan, Professor of Medicine, College of Medicine, Mayo Clinic: BMI; Fat Mass; Weight Loss; Body Circumference Reduction
• Additional relevant MeSH terms: Overweight; Weight Loss

Study Results

No Results Posted as of Jun 8, 2022