LLLT for Reducing Waste Circumference and Weight (LLLT)

• ClinicalTrials.gov Identifier: NCT02877004
• Recruitment Status: Completed
• First Posted: August 24, 2016
• Results First Posted: September 13, 2019
• Last Update Posted: September 13, 2019
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Ivana Croghan, Mayo Clinic

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.

Condition or disease	Intervention/treatment	Phase
Weight Loss	Device: 3 Low-Level Laser Therapy Treatments Weekly; Device: 2 Low-Level Laser Therapy Treatments Weekly; Device: 1 Low-Level Laser Therapy Treatment Weekly	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Feasibility Study Addressing the Frequency of Low Level Laser Therapy for Reducing Central Adiposity and Weight in Overweight Individuals
• Actual Study Start Date: September 30, 2016
• Actual Primary Completion Date: July 28, 2018
• Actual Study Completion Date: August 28, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change in Weight [ Time Frame: baseline and 4 weeks ]
   Comparison of weight change from baseline between arms
2. Change in Waist Circumference [ Time Frame: baseline and 4 weeks ]
   Comparison of waist circumference change from baseline between arms

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Minnesota

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Investigators

• Principal Investigator: Ivana T Croghan, PhD; Mayo Clinic

  Study Documents (Full-Text)

Documents provided by Ivana Croghan, Mayo Clinic:

Study Protocol and Statistical Analysis Plan  [PDF] October 28, 2016

More Information

Publications of Results:

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.

• Responsible Party: Ivana Croghan, Professor, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02877004
• Other Study ID Numbers: 16-004817
• First Posted: August 24, 2016
• Results First Posted: September 13, 2019
• Last Update Posted: September 13, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Body Weight; Weight Loss; Body Weight Changes