Overweight and Obesity, Weight Loss
Conditions
Keywords
BMI, Fat Mass, Weight Loss, Body Circumference Reduction
Brief summary
The purpose of this research study is to evaluate the effectiveness of Low Level Laser Therapy in combination with Lifestyle Modifications in helping people reduce the extra weight and size in the central body region
Detailed description
Subjects will undergo Low Level Laser Therapy or Sham (placebo) treatments while incorporating lifestyle modifications through of wellness coaching.
Interventions
DEVICELow Level Laser Therapy
Non-surgical cosmetic treatment which can be used by individuals intending to reduce size of the mid-section
OTHERSham (placebo)
Use of sham (placebo) option
Sponsors
Erchonia Corporation
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Randomization will be set up by a statistician through REDCap, the data collection system utilized for the study.
Intervention model description
Randomized clinical trial where subjects are placed into 2 different study arms. Subjects randomized to 2 groups that either receive Low Level Laser therapy with lifestyle modifications or Sham (placebo) with Lifestyle Modifications.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. 18 years of age or older 2. have a BMI 25-39.9 kg/m2 3. be able to participate fully in all aspects of the study; and 4. have understood and signed study informed consent
Exclusion criteria
1. have used weight loss medications or participated in a weight loss program within the past 30 days 2. are currently taking medications or supplements known to affect weight, such as insulin or sulfonylurea, prednisone or garcinia cambrogia 3. have had weight fluctuations of 5 pounds or more in the past month 4. have an implanted device (including pacemaker or lap band) in the targeted area of LLLT 5. have a known active eating disorder 6. have a known, active, untreated clinically significant psychiatric condition (alcohol or substance abuse, psychosis, bipolar disorder, or depression) 7. have used an investigational drug within 30 days of study enrollment 8. Reports being currently pregnant, lactating, or are of child-bearing potential or are likely to become pregnant during the low-level laser therapy treatment phase and are unwilling to use a reliable form of contraception. Acceptable forms include: 1. Hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants 2. Barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm) 3. Intrauterine device (IUD) 4. Total hysterectomy or tubal ligation 5. Abstinence (no sex) 9. have a history of any major cardiovascular events including heart valve disease, ongoing angina, cardiac arrhythmias, congestive heart failure, acute coronary syndrome, stroke, transient ischemic attack, or peripheral vascular disease 10. have current uncontrolled hypertension (systolic \> 160 mm Hg or diastolic \> 95 mm Hg) documented on 2 separate occasions 11. have clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, lymphatic, respiratory, or metabolic disease (such as uncontrolled diabetes type 2) or active cancer or are within 1 year of cancer remission 12. surgical intervention for body sculpting/weight loss, such as liposuction, abdominoplasty, stomach stapling, lap band surgery, etc. within 12 months prior to enrollment 13. medical, physical, or other contraindications for body sculpting/weight loss 14. any medical condition known to affect weight levels and/or to cause bloating or swelling 15. a 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 cancer; or 19. have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fat Mass From Baseline to 6 Weeks | 6 weeks | The change in fat mass from baseline to the end of treatments at 6 weeks |
| Change in Waist Circumference From Baseline to 6 Weeks | 6 weeks | The change in waist circumference from baseline to the end of treatments at 6 weeks |
Countries
United States
Participant flow
Recruitment details
Participants will be recruited from the local community through internet postings, Mayo Clinic physician referrals, and word of mouth.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 - LLLT Subject receive Laser treatments and Lifestyle Modifications
Low Level Laser Therapy: Non-surgical cosmetic treatment which can be used by individuals intending to reduce size of the mid-section | 30 |
| Group 2 - SHAM Subject receives Sham Laser treatments and Lifestyle Modifications
Sham (placebo): Use of sham (placebo) option | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | scheduling difficulties | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Group 1 - LLLT | Group 2 - SHAM | Total |
|---|---|---|---|
| Age, Continuous | 41.7 years STANDARD_DEVIATION 10.1 | 37.7 years STANDARD_DEVIATION 11.7 | 39.7 years STANDARD_DEVIATION 11.1 |
| Race/Ethnicity, Customized race/ethnicity other | 2 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized race/ethnicity white, not hispanic | 28 Participants | 26 Participants | 54 Participants |
| Sex: Female, Male Female | 27 Participants | 22 Participants | 49 Participants |
| Sex: Female, Male Male | 3 Participants | 8 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 6 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Change in Fat Mass From Baseline to 6 Weeks
The change in fat mass from baseline to the end of treatments at 6 weeks
Time frame: 6 weeks
Population: Analysis population includes subjects with non-missing values for given outcome (change in fat mass at 6 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 - LLLT | Change in Fat Mass From Baseline to 6 Weeks | -1.3 Kg | Standard Deviation 1.5 |
| Group 2 - SHAM | Change in Fat Mass From Baseline to 6 Weeks | -2.0 Kg | Standard Deviation 2.4 |
Comparison: Groups were compared using analysis of covariance with baseline included as the covariate.p-value: 0.1995% CI: [-0.4, 1.9]ANCOVA
Primary
Change in Waist Circumference From Baseline to 6 Weeks
The change in waist circumference from baseline to the end of treatments at 6 weeks
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 - LLLT | Change in Waist Circumference From Baseline to 6 Weeks | -1.8 cm | Standard Deviation 3.5 |
| Group 2 - SHAM | Change in Waist Circumference From Baseline to 6 Weeks | -1.8 cm | Standard Deviation 4 |
Comparison: Groups were compared using analysis of covariance with baseline included as the covariate.p-value: 0.74595% CI: [-1.5, 2.1]ANCOVA