LLLT for Reducing Waste Circumference and Weight (LLLT)

A Feasibility Study Addressing the Frequency of Low Level Laser Therapy for Reducing Central Adiposity and Weight in Overweight Individuals

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss
• Intervention / Treatment: Device: 3 Low-Level Laser Therapy Treatments Weekly; Device: 2 Low-Level Laser Therapy Treatments Weekly; Device: 1 Low-Level Laser Therapy Treatment Weekly

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Laser for 4 weeks; 3 Low-Level Laser Therapy Treatments Weekly	Device: 3 Low-Level Laser Therapy Treatments Weekly; Receives 12 LLLT treatment - at a frequency of 3 times per week for 4 weeks
Active Comparator: Laser for 6 weeks; 2 Low-Level Laser Therapy Treatments Weekly	Device: 2 Low-Level Laser Therapy Treatments Weekly; Receives 12 LLLT treatments - at a frequency of 2 times per week for 6 weeks
Active Comparator: Laser for 12 weeks; 1 Low-Level Laser Therapy Treatment Weekly	Device: 1 Low-Level Laser Therapy Treatment Weekly; Receive 12 LLLT treatments - at a frequency of once per week for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Weight	Comparison of weight change from baseline between arms	baseline and 4 weeks
Change in Waist Circumference	Comparison of waist circumference change from baseline between arms	baseline and 4 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

General Publications

• Croghan IT, Hurt RT, Schroeder DR, Fokken SC, Jensen MD, Clark MM, Ebbert JO. Low-level laser therapy for weight reduction: a randomized pilot study. Lasers Med Sci. 2020 Apr;35(3):663-675. doi: 10.1007/s10103-019-02867-5. Epub 2019 Aug 31.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2016
• Primary Completion (Actual): July 28, 2018
• Study Completion (Actual): August 28, 2018

Study Registration Dates

• First Submitted: August 17, 2016
• First Submitted That Met QC Criteria: August 23, 2016
• First Posted (Estimate): August 24, 2016

Study Record Updates

• Last Update Posted (Actual): September 13, 2019
• Last Update Submitted That Met QC Criteria: September 9, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: 16-004817

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No