Trial Outcomes & Findings for LLLT for Reducing Waste Circumference and Weight (NCT NCT02877004)

NCT ID: NCT02877004

Last Updated: 2019-09-13

Results Overview

Comparison of weight change from baseline between arms

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: baseline and 4 weeks
• Results posted on: 2019-09-13

Participant Flow

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.

After consent, patients were screened for study entry criteria. Only those who passed all criteria were invited to be randomized to study.

Participant milestones

Measure	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	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	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
Overall Study STARTED	20	20	20
Overall Study COMPLETED	20	20	19
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Measure	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	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	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
Overall Study Pregnancy	0	0	1

Baseline Characteristics

LLLT for Reducing Waste Circumference and Weight

Baseline characteristics by cohort

Measure	Laser for 4 Weeks n=20 Participants 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	Laser for 6 Weeks n=20 Participants 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	Laser for 12 Weeks n=20 Participants 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	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	20 Participants n=7 Participants	19 Participants n=5 Participants	59 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Age, Continuous	44.6 years STANDARD_DEVIATION 8.3 • n=5 Participants	40.8 years STANDARD_DEVIATION 8.7 • n=7 Participants	45.8 years STANDARD_DEVIATION 10.1 • n=5 Participants	43.7 years STANDARD_DEVIATION 9.2 • n=4 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	20 Participants n=7 Participants	19 Participants n=5 Participants	54 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Race/Ethnicity, Customized Race/Ethnicity · White/Non Hispanic	18 Participants n=5 Participants	20 Participants n=7 Participants	19 Participants n=5 Participants	57 Participants n=4 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Weight (kg)	81.7 Kg STANDARD_DEVIATION 10.5 • n=5 Participants	77.1 Kg STANDARD_DEVIATION 6.8 • n=7 Participants	75.4 Kg STANDARD_DEVIATION 7.9 • n=5 Participants	78.1 Kg STANDARD_DEVIATION 8.8 • n=4 Participants
Waist Circumference (cm)	93.2 cm STANDARD_DEVIATION 7.0 • n=5 Participants	91.4 cm STANDARD_DEVIATION 7.2 • n=7 Participants	91.2 cm STANDARD_DEVIATION 6.5 • n=5 Participants	91.9 cm STANDARD_DEVIATION 6.9 • n=4 Participants

PRIMARY outcome

Timeframe: baseline and 4 weeks

Comparison of weight change from baseline between arms

Outcome measures

Measure	Laser for 4 Weeks n=20 Participants 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	Laser for 6 Weeks n=20 Participants 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	Laser for 12 Weeks n=20 Participants 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
Change in Weight	-0.5 Kg Standard Deviation 1.7	-0.9 Kg Standard Deviation 1.7	-0.6 Kg Standard Deviation 1.5

PRIMARY outcome

Timeframe: baseline and 4 weeks

Comparison of waist circumference change from baseline between arms

Outcome measures

Measure	Laser for 4 Weeks n=20 Participants 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	Laser for 6 Weeks n=20 Participants 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	Laser for 12 Weeks n=20 Participants 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
Change in Waist Circumference	-1.4 cm Standard Deviation 2.3	-2.0 cm Standard Deviation 2.5	-0.8 cm Standard Deviation 2.6

Adverse Events

Laser for 4 Weeks

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Laser for 6 Weeks

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Laser for 12 Weeks

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Laser for 4 Weeks n=20 participants at risk 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	Laser for 6 Weeks n=20 participants at risk 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	Laser for 12 Weeks n=20 participants at risk 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
Pregnancy, puerperium and perinatal conditions Pregnancy	0.00% 0/20 • 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). All Adverse Events that met criteria for being Serious Adverse Events were recorded and followed up; In addition, adverse events not meeting SAE criteria and considered to be potentially related to the LLLT were also documented.	0.00% 0/20 • 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). All Adverse Events that met criteria for being Serious Adverse Events were recorded and followed up; In addition, adverse events not meeting SAE criteria and considered to be potentially related to the LLLT were also documented.	5.0% 1/20 • Number of events 1 • 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). All Adverse Events that met criteria for being Serious Adverse Events were recorded and followed up; In addition, adverse events not meeting SAE criteria and considered to be potentially related to the LLLT were also documented.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ivana Croghan

Mayo Clinic

Phone: 507-266-1944

Email: nicotineresearch@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place