Low-level Laser and Lifestyle Modifications

Not Applicable

Active, not recruiting

• Conditions: Overweight and Obesity; Weight Loss
• Interventions: Device: Low Level Laser Therapy; Other: Sham (placebo)

• Registration Number: NCT05083442
• Lead Sponsor: Mayo Clinic

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2021-10-06
• Study First Submitted QC: 2021-10-06
• Study First Posted: 2021-10-19
• Study Start: 2022-06-01
• Primary Completion: 2024-04-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-10
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 - LLLT	Low Level Laser Therapy	Subject receive Laser treatments and Lifestyle Modifications
Group 2 - SHAM	Sham (placebo)	Subject receives Sham Laser treatments and Lifestyle Modifications

Primary Outcome Measures

Name	Time	Method
Amount of fat mass loss	6 weeks	Compare the amount of fat mass loss at the end of treatments

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States