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LLLT for Reducing Waste Circumference and Weight (LLLT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Ivana Croghan, 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.

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

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




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02877004


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Ivana T Croghan, PhD Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Ivana Croghan, Mayo Clinic:
Publications of Results:
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Responsible Party: Ivana Croghan, Professor, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02877004    
Other Study ID Numbers: 16-004817
First Posted: August 24, 2016    Key Record Dates
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:
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Body Weight
Weight Loss
Body Weight Changes