N/A
N=60
LLLT for Reducing Waste Circumference and Weight
Weight Loss
Bottom Line
View on ClinicalTrials.gov: NCT02877004 ↗Enrolled (actual)
60
Serious AEs
1.7%
Results posted
Sep 2019
Primary outcome: Primary: Change in Weight — -0.5; -0.9; -0.6 Kg — p=0.723
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 3 Low-Level Laser Therapy Treatments Weekly (Device); 2 Low-Level Laser Therapy Treatments Weekly (Device); 1 Low-Level Laser Therapy Treatment Weekly (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Weight |
-0.5; -0.9; -0.6 | 0.723 |
| PRIMARY Change in Waist Circumference |
-1.4; -2.0; -0.8 | .368 |
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.
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
Data sourced from ClinicalTrials.gov (NCT02877004). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.