Weight Loss
Conditions
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.
Interventions
DEVICE3 Low-Level Laser Therapy Treatments Weekly
Receives 12 LLLT treatment - at a frequency of 3 times per week for 4 weeks
DEVICE2 Low-Level Laser Therapy Treatments Weekly
Receives 12 LLLT treatments - at a frequency of 2 times per week for 6 weeks
DEVICE1 Low-Level Laser Therapy Treatment Weekly
Receive 12 LLLT treatments - at a frequency of once per week for 12 weeks
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Waist Circumference | baseline and 4 weeks | Comparison of waist circumference change from baseline between arms |
| Change in Weight | baseline and 4 weeks | Comparison of weight change from baseline between arms |
Countries
United States
Participant flow
Recruitment details
Participants recruited from the local community of Rochester, MN, 09/16-08/17. All interested individuals called a central number and underwent a 10-minute phone pre-screen. If they passed the telephone pre-screen, they were invited to attend an in-person consent visit. All study visits and treatments took place in Mayo Clinic - Rochester Campus.
Pre-assignment details
After consent, patients were screened for study entry criteria. Only those who passed all criteria were invited to be randomized to study.
Participants by arm
| Arm | Count |
|---|---|
| Laser for 4 Weeks 3 Low-Level Laser Therapy Treatments Weekly
3 Low-Level Laser Therapy Treatments Weekly: Receives 12 LLLT treatment - at a frequency of 3 times per week for 4 weeks | 20 |
| Laser for 6 Weeks 2 Low-Level Laser Therapy Treatments Weekly
2 Low-Level Laser Therapy Treatments Weekly: Receives 12 LLLT treatments - at a frequency of 2 times per week for 6 weeks | 20 |
| Laser for 12 Weeks 1 Low-Level Laser Therapy Treatment Weekly
1 Low-Level Laser Therapy Treatment Weekly: Receive 12 LLLT treatments - at a frequency of once per week for 12 weeks | 20 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Pregnancy | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Laser for 4 Weeks | Total | Laser for 12 Weeks | Laser for 6 Weeks |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 59 Participants | 19 Participants | 20 Participants |
| Age, Continuous | 44.6 years STANDARD_DEVIATION 8.3 | 43.7 years STANDARD_DEVIATION 9.2 | 45.8 years STANDARD_DEVIATION 10.1 | 40.8 years STANDARD_DEVIATION 8.7 |
| Race/Ethnicity, Customized Race/Ethnicity Other | 2 Participants | 3 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White/Non Hispanic | 18 Participants | 57 Participants | 19 Participants | 20 Participants |
| Sex: Female, Male Female | 15 Participants | 54 Participants | 19 Participants | 20 Participants |
| Sex: Female, Male Male | 5 Participants | 6 Participants | 1 Participants | 0 Participants |
| Waist Circumference (cm) | 93.2 cm STANDARD_DEVIATION 7 | 91.9 cm STANDARD_DEVIATION 6.9 | 91.2 cm STANDARD_DEVIATION 6.5 | 91.4 cm STANDARD_DEVIATION 7.2 |
| Weight (kg) | 81.7 Kg STANDARD_DEVIATION 10.5 | 78.1 Kg STANDARD_DEVIATION 8.8 | 75.4 Kg STANDARD_DEVIATION 7.9 | 77.1 Kg STANDARD_DEVIATION 6.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 1 / 20 |
Outcome results
Primary
Change in Waist Circumference
Comparison of waist circumference change from baseline between arms
Time frame: baseline and 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laser for 4 Weeks | Change in Waist Circumference | -1.4 cm | Standard Deviation 2.3 |
| Laser for 6 Weeks | Change in Waist Circumference | -2.0 cm | Standard Deviation 2.5 |
| Laser for 12 Weeks | Change in Waist Circumference | -0.8 cm | Standard Deviation 2.6 |
p-value: 0.368ANCOVA
Primary
Change in Weight
Comparison of weight change from baseline between arms
Time frame: baseline and 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laser for 4 Weeks | Change in Weight | -0.5 Kg | Standard Deviation 1.7 |
| Laser for 6 Weeks | Change in Weight | -0.9 Kg | Standard Deviation 1.7 |
| Laser for 12 Weeks | Change in Weight | -0.6 Kg | Standard Deviation 1.5 |
p-value: 0.723ANCOVA