NCT02877004: LLLT

LLLT for Reducing Waste Circumference and Weight

Completed NA Results posted Last updated 13 September 2019

What this trial tests

NA trial testing 3 Low-Level Laser Therapy Treatments Weekly in Weight Loss in 60 participants. Completed in 28 August 2018.

Timeline

30 September 2016

Primary endpoint
28 July 2018

28 August 2018

Quick facts

Lead sponsor	Mayo Clinic
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	30 September 2016
Primary completion	28 July 2018
Estimated completion	28 August 2018
Sites	1 location across United States

Drugs / interventions tested

• 3 Low-Level Laser Therapy Treatments Weekly
• 2 Low-Level Laser Therapy Treatments Weekly
• 1 Low-Level Laser Therapy Treatment Weekly

Conditions studied

• Weight Loss — all drugs for Weight Loss →

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Weight Loss. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Weight Primary · baseline and 4 weeks

Comparison of weight change from baseline between arms

Group	Value	95% CI
Laser for 4 Weeks	-0.5	± 1.7
Laser for 6 Weeks	-0.9	± 1.7
Laser for 12 Weeks	-0.6	± 1.5

Change in Waist Circumference Primary · baseline and 4 weeks

Comparison of waist circumference change from baseline between arms

Group	Value	95% CI
Laser for 4 Weeks	-1.4	± 2.3
Laser for 6 Weeks	-2.0	± 2.5
Laser for 12 Weeks	-0.8	± 2.6

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected during LLLT treatment for each group (4 weeks for group A; 6 weeks for group B; 12 weeks for group C).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Laser for 4 Weeks

Serious: 0/20 (0%)

Deaths: 0/20

Laser for 6 Weeks

Serious: 0/20 (0%)

Deaths: 0/20

Laser for 12 Weeks

Serious: 1/20 (5%)

Deaths: 0/20

Serious adverse events (1 terms)

Reaction	System	Laser for 4 Weeks	Laser for 6 Weeks	Laser for 12 Weeks
Pregnancy	Pregnancy, puerperium and perinatal conditions	—	—	—

Most-reported serious reactions: Pregnancy.

Data from ClinicalTrials.gov NCT02877004 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Low-level laser therapy for weight reduction: a randomized pilot study.
   Croghan IT, Hurt RT, Schroeder DR, Fokken SC, et al · · 2020 · cited 16× · PMID 31473867 · DOI 10.1007/s10103-019-02867-5