Low-level Laser and Lifestyle Modifications

NCT ID: NCT05083442

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2024-12-30

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.

Conditions

Overweight and Obesity; Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1 - LLLT

Subject receive Laser treatments and Lifestyle Modifications

Group Type: ACTIVE_COMPARATOR

Low Level Laser Therapy

Intervention Type: DEVICE

Non-surgical cosmetic treatment which can be used by individuals intending to reduce size of the mid-section

Group 2 - SHAM

Subject receives Sham Laser treatments and Lifestyle Modifications

Group Type: SHAM_COMPARATOR

Sham (placebo)

Intervention Type: OTHER

Use of sham (placebo) option

Interventions

Low Level Laser Therapy

Non-surgical cosmetic treatment which can be used by individuals intending to reduce size of the mid-section

Intervention Type: DEVICE

Sham (placebo)

Use of sham (placebo) option

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Erchonia Corporation

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Ivana T Croghan, PhD

Professor of Medicine, College of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ivana T Croghan, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor of Medicine, College of Medicine

Ryan T Hurt, MD, PhD

Role: STUDY_DIRECTOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

21-008379

Identifier Type: -

Identifier Source: org_study_id