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LLLT for Reducing Waste Circumference and Weight (LLLT)

Primary Purpose

Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3 Low-Level Laser Therapy Treatments Weekly
2 Low-Level Laser Therapy Treatments Weekly
1 Low-Level Laser Therapy Treatment Weekly
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Laser for 4 weeks

Laser for 6 weeks

Laser for 12 weeks

Arm Description

3 Low-Level Laser Therapy Treatments Weekly

2 Low-Level Laser Therapy Treatments Weekly

1 Low-Level Laser Therapy Treatment Weekly

Outcomes

Primary Outcome Measures

Change in Weight
Comparison of weight change from baseline between arms
Change in Waist Circumference
Comparison of waist circumference change from baseline between arms

Secondary Outcome Measures

Full Information

First Posted
August 17, 2016
Last Updated
September 9, 2019
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02877004
Brief Title
LLLT for Reducing Waste Circumference and Weight
Acronym
LLLT
Official Title
A Feasibility Study Addressing the Frequency of Low Level Laser Therapy for Reducing Central Adiposity and Weight in Overweight Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 30, 2016 (Actual)
Primary Completion Date
July 28, 2018 (Actual)
Study Completion Date
August 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser for 4 weeks
Arm Type
Active Comparator
Arm Description
3 Low-Level Laser Therapy Treatments Weekly
Arm Title
Laser for 6 weeks
Arm Type
Active Comparator
Arm Description
2 Low-Level Laser Therapy Treatments Weekly
Arm Title
Laser for 12 weeks
Arm Type
Active Comparator
Arm Description
1 Low-Level Laser Therapy Treatment Weekly
Intervention Type
Device
Intervention Name(s)
3 Low-Level Laser Therapy Treatments Weekly
Intervention Description
Receives 12 LLLT treatment - at a frequency of 3 times per week for 4 weeks
Intervention Type
Device
Intervention Name(s)
2 Low-Level Laser Therapy Treatments Weekly
Intervention Description
Receives 12 LLLT treatments - at a frequency of 2 times per week for 6 weeks
Intervention Type
Device
Intervention Name(s)
1 Low-Level Laser Therapy Treatment Weekly
Intervention Description
Receive 12 LLLT treatments - at a frequency of once per week for 12 weeks
Primary Outcome Measure Information:
Title
Change in Weight
Description
Comparison of weight change from baseline between arms
Time Frame
baseline and 4 weeks
Title
Change in Waist Circumference
Description
Comparison of waist circumference change from baseline between arms
Time Frame
baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: over 18 years of age; body weight of greater than 50 kg (110 pounds); BMI between 25-29.9 kg/m2; able to participate fully in all aspects of the study understood and signed study informed consent Exclusion Criteria: used weight loss medications or participated in a weight loss program within past 30 days currently taking supplements known to affect weight (garcinia cambogia, etc.) weight fluctuations of 20 pounds or more in the past 6 months implanted device (including pacemaker or lap band) in the targeted area of LLLT known active eating disorder known, active, untreated clinically significant psychiatric condition (alcohol or substance abuse, psychosis, bipolar disorder, or depression) used an investigational drug within 30 days of study enrollment 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 history of any major cardiovascular events current uncontrolled hypertension clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, lymphatic, respiratory, or metabolic disease Prior surgical intervention for body sculpting/weight loss medical, physical, or other contraindications for body sculpting/weight loss any medical condition known to affect weight levels or to cause bloating or swelling diagnosis of, and/or taking medication for, irritable bowel syndrome active infection, wound or other external trauma to the areas to be treated with the laser known photosensitivity disorder; current active cancer or currently receiving treatment for or within 1 year of cancer remission
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivana T Croghan, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31473867
Citation
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.
Results Reference
result

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LLLT for Reducing Waste Circumference and Weight

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