LLLT for Reducing Waste Circumference and Weight

Not Applicable

Completed

• Conditions: Weight Loss
• Interventions: Device: 2 Low-Level Laser Therapy Treatments Weekly; Device: 3 Low-Level Laser Therapy Treatments Weekly; Device: 1 Low-Level Laser Therapy Treatment Weekly

• Registration Number: NCT02877004
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this research is to gather preliminary information on the effectiveness of Low Level Laser Therapy (LLLT) in helping people reduce their weight gain in the central body region.

Detailed Description

This will be an open label clinical trial with all study participants receiving LLLT. Preliminary data will be collected on the efficacy of LLLT based on varying frequency of treatments. The focus of this study on 60 overweight adults with a BMI of 25 to 29.9, and assess changes in weight and waist circumference at end of treatment for group 1 (week 4) and group 2 (week 6) and group 3 (week 12). Participants will be randomized to receive LLLT treatments either 3 times a week; 2 times a week; or once a week.

Study Timeline

• Study First Submitted: 2016-08-17
• Study First Submitted QC: 2016-08-23
• Study First Posted: 2016-08-24
• Study Start: 2016-09-30
• Primary Completion: 2018-07-28
• Study Completion: 2018-08-28
• Results First Submitted: 2019-08-12
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-09
• Last Update Submitted: 2019-09-09
• Results First Posted: 2019-09-13
• Last Update Posted: 2019-09-13

Recruitment & Eligibility

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

Inclusion Criteria

1. over 18 years of age;
2. body weight of greater than 50 kg (110 pounds);
3. BMI between 25-29.9 kg/m2;
4. able to participate fully in all aspects of the study
5. understood and signed study informed consent

Exclusion Criteria

1. used weight loss medications or participated in a weight loss program within past 30 days
2. currently taking supplements known to affect weight (garcinia cambogia, etc.)
3. weight fluctuations of 20 pounds or more in the past 6 months
4. implanted device (including pacemaker or lap band) in the targeted area of LLLT
5. known active eating disorder
6. known, active, untreated clinically significant psychiatric condition (alcohol or substance abuse, psychosis, bipolar disorder, or depression)
7. used an investigational drug within 30 days of study enrollment
8. currently pregnant or lactating, or are of child-bearing potential or are likely to become pregnant during the medication phase and unwilling to use a reliable form of contraception
9. history of any major cardiovascular events
10. current uncontrolled hypertension
11. clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, lymphatic, respiratory, or metabolic disease
12. Prior surgical intervention for body sculpting/weight loss
13. medical, physical, or other contraindications for body sculpting/weight loss
14. any medical condition known to affect weight levels or to cause bloating or swelling
15. 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 or within 1 year of cancer remission

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser for 6 weeks	2 Low-Level Laser Therapy Treatments Weekly	2 Low-Level Laser Therapy Treatments Weekly
Laser for 4 weeks	3 Low-Level Laser Therapy Treatments Weekly	3 Low-Level Laser Therapy Treatments Weekly
Laser for 12 weeks	1 Low-Level Laser Therapy Treatment Weekly	1 Low-Level Laser Therapy Treatment Weekly

Primary Outcome Measures

Name	Time	Method
Change in Weight	baseline and 4 weeks	Comparison of weight change from baseline between arms
Change in Waist Circumference	baseline and 4 weeks	Comparison of waist circumference change from baseline between arms

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States