LLLT for Reducing Waste Circumference and Weight

Weight Loss Clinical Trial

— LLLT  

Official title:

A Feasibility Study Addressing the Frequency of Low Level Laser Therapy for Reducing Central Adiposity and Weight in Overweight Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02877004
• Other study ID #: 16-004817
• Status: Completed
• Phase: N/A
• Start date: September 30, 2016
• Est. completion date: August 28, 2018

Study information

• Verified date: September 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 28, 2018
• Est. primary completion date: July 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Weight Loss

Intervention

Device:
• 3 Low-Level Laser Therapy Treatments Weekly
Receives 12 LLLT treatment - at a frequency of 3 times per week for 4 weeks
• 2 Low-Level Laser Therapy Treatments Weekly
Receives 12 LLLT treatments - at a frequency of 2 times per week for 6 weeks
• 1 Low-Level Laser Therapy Treatment Weekly
Receive 12 LLLT treatments - at a frequency of once per week for 12 weeks

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. 2019 Aug 31. doi: 10.1007/s10103-019-02867-5. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Weight	Comparison of weight change from baseline between arms	baseline and 4 weeks
Primary	Change in Waist Circumference	Comparison of waist circumference change from baseline between arms	baseline and 4 weeks