Trial Outcomes & Findings for Low-level Laser and Lifestyle Modifications (NCT NCT05083442)
NCT ID: NCT05083442
Last Updated: 2025-04-03
Results Overview
The change in fat mass from baseline to the end of treatments at 6 weeks
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
6 weeks
Results posted on
2025-04-03
Participant Flow
Participants will be recruited from the local community through internet postings, Mayo Clinic physician referrals, and word of mouth.
Participant milestones
| Measure |
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
|
Group 2 - SHAM
Subject receives Sham Laser treatments and Lifestyle Modifications
Sham (placebo): Use of sham (placebo) option
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
27
|
24
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
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
|
Group 2 - SHAM
Subject receives Sham Laser treatments and Lifestyle Modifications
Sham (placebo): Use of sham (placebo) option
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
scheduling difficulties
|
1
|
2
|
Baseline Characteristics
Low-level Laser and Lifestyle Modifications
Baseline characteristics by cohort
| Measure |
Group 1 - LLLT
n=30 Participants
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
|
Group 2 - SHAM
n=30 Participants
Subject receives Sham Laser treatments and Lifestyle Modifications
Sham (placebo): Use of sham (placebo) option
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.7 years
STANDARD_DEVIATION 10.1 • n=99 Participants
|
37.7 years
STANDARD_DEVIATION 11.7 • n=107 Participants
|
39.7 years
STANDARD_DEVIATION 11.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
race/ethnicity · white, not hispanic
|
28 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
race/ethnicity · other
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Analysis population includes subjects with non-missing values for given outcome (change in fat mass at 6 weeks)
The change in fat mass from baseline to the end of treatments at 6 weeks
Outcome measures
| Measure |
Group 1 - LLLT
n=25 Participants
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
|
Group 2 - SHAM
n=24 Participants
Subject receives Sham Laser treatments and Lifestyle Modifications
Sham (placebo): Use of sham (placebo) option
|
|---|---|---|
|
Change in Fat Mass From Baseline to 6 Weeks
|
-1.3 Kg
Standard Deviation 1.5
|
-2.0 Kg
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: 6 weeksThe change in waist circumference from baseline to the end of treatments at 6 weeks
Outcome measures
| Measure |
Group 1 - LLLT
n=25 Participants
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
|
Group 2 - SHAM
n=24 Participants
Subject receives Sham Laser treatments and Lifestyle Modifications
Sham (placebo): Use of sham (placebo) option
|
|---|---|---|
|
Change in Waist Circumference From Baseline to 6 Weeks
|
-1.8 cm
Standard Deviation 3.5
|
-1.8 cm
Standard Deviation 4.0
|
Adverse Events
Group 1 - LLLT
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Group 2 - SHAM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1 - LLLT
n=30 participants at risk
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
|
Group 2 - SHAM
n=30 participants at risk
Subject receives Sham Laser treatments and Lifestyle Modifications
Sham (placebo): Use of sham (placebo) option
|
|---|---|---|
|
Gastrointestinal disorders
Loose Stool
|
10.0%
3/30 • Number of events 3 • AE's were collected over the 6 weeks of the LLLT intervention.
|
0.00%
0/30 • AE's were collected over the 6 weeks of the LLLT intervention.
|
|
Musculoskeletal and connective tissue disorders
muscle contraction/tingling
|
10.0%
3/30 • Number of events 3 • AE's were collected over the 6 weeks of the LLLT intervention.
|
0.00%
0/30 • AE's were collected over the 6 weeks of the LLLT intervention.
|
|
Gastrointestinal disorders
stomach/gas pain
|
6.7%
2/30 • Number of events 2 • AE's were collected over the 6 weeks of the LLLT intervention.
|
0.00%
0/30 • AE's were collected over the 6 weeks of the LLLT intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place