Overweight and ObesityLLLTNCT05083442
Low-level Laser and Lifestyle Modifications
A study testing Low Level Laser Therapy in people with Overweight and Obesity and Weight Loss, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate the effectiveness of Low Level Laser Therapy in combination with Lifestyle Modifications in helping people reduce the extra weight and size in the central body region Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Weight Loss
- What is being tested?
- Low Level Laser Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- have a BMI 25-39.9 kg/m2
- be able to participate fully in all aspects of the study; and
- have understood and signed study informed consent
Who cannot join
- have used weight loss medications or participated in a weight loss program within the past 30 days
- are currently taking medications or supplements known to affect weight, such as insulin or sulfonylurea, prednisone or garcinia cambrogia
- have had weight fluctuations of 5 pounds or more in the past month
- have an implanted device (including pacemaker or lap band) in the targeted area of LLLT
- have a known active eating disorder
- have a known, active, untreated clinically significant psychiatric condition (alcohol or substance abuse, psychosis, bipolar disorder, or depression)
Show all 24Show fewer
- have used an investigational drug within 30 days of study enrollment
- Reports being currently pregnant, lactating, or are of child-bearing potential or are likely to become pregnant during the low-level laser therapy treatment phase and are unwilling to use a reliable form of contraception. Acceptable forms include:
- Hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants
- Barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm)
- Intrauterine device (IUD)
- Total hysterectomy or tubal ligation
- Abstinence (no sex)
- have a history of any major cardiovascular events including heart valve disease, ongoing angina, cardiac arrhythmias, congestive heart failure, acute coronary syndrome, stroke, transient ischemic attack, or peripheral vascular disease
- have current uncontrolled hypertension (systolic > 160 mm Hg or diastolic > 95 mm Hg) documented on 2 separate occasions
- have clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, lymphatic, respiratory, or metabolic disease (such as uncontrolled diabetes type 2) or active cancer or are within 1 year of cancer remission
- surgical intervention for body sculpting/weight loss, such as liposuction, abdominoplasty, stomach stapling, lap band surgery, etc. within 12 months prior to enrollment
- medical, physical, or other contraindications for body sculpting/weight loss
- any medical condition known to affect weight levels and/or to cause bloating or swelling
- a diagnosis of, and/or taking medication for, irritable bowel syndrome
- active infection, wound or other external trauma to the areas to be treated with the laser
- known photosensitivity disorder
- current active cancer or currently receiving treatment for cancer; or
- have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study Addressing the Adjunct Use of Low-Level Laser to Mayo Lifestyle Modification Education and Wellness Coaching for Reducing Central Adiposity and Fat Mass
The purpose of this research study is to evaluate the effectiveness of Low Level Laser Therapy in combination with Lifestyle Modifications in helping people reduce the extra weight and size in the central body region
Read the detailed description
Subjects will undergo Low Level Laser Therapy or Sham (placebo) treatments while incorporating lifestyle modifications through of wellness coaching.
- Conditions
- Overweight and Obesity, Weight Loss
- Being tested
- Low Level Laser Therapy, Sham (placebo)
- Keywords
- BMI, Fat Mass, Weight Loss, Body Circumference Reduction
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Laser TherapyDevice
Non-surgical cosmetic treatment which can be used by individuals intending to reduce size of the mid-section
Sham (placebo)Other
Use of sham (placebo) option
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - LLLT | Active comparator | Subject receive Laser treatments and Lifestyle Modifications Receives: Device: Low Level Laser Therapy |
| Group 2 - SHAM | Sham comparator | Subject receives Sham Laser treatments and Lifestyle Modifications Receives: Other: Sham (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fat Mass From Baseline to 6 Weeks
The change in fat mass from baseline to the end of treatments at 6 weeks
Measured: 6 weeks
Change in Waist Circumference From Baseline to 6 Weeks
The change in waist circumference from baseline to the end of treatments at 6 weeks
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start1 Jun 2022
- Primary completion30 Apr 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial where subjects are placed into 2 different study arms. Subjects randomized to 2 groups that either receive Low Level Laser therapy with lifestyle modifications or Sham (placebo) with Lifestyle Modifications.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Erchonia Corporation
- Responsible party
- Principal investigator, Ivana T Croghan, PhD, Mayo Clinic
- Investigators
- Ivana T Croghan, PhD, Principal investigator, Professor of Medicine, College of MedicineRyan T Hurt, MD, PhD, Study director, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083442
- Sponsor's protocol ID
- 21-008379
- Acronym
- LLLT
- Status last verified
- Apr 2025
- First submitted
- 6 Oct 2021
- Last updated
- 3 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study Addressing the Adjunct Use of Low-Level Laser to Mayo Lifestyle Modification Education and Wellness Coaching for Reducing Central Adiposity and Fat Mass
- ClinicalTrials.gov ID
- NCT05083442
- Acronym / sponsor ID
- LLLT / 21-008379
- Conditions
- Overweight and Obesity, Weight Loss
- Keywords
- BMI, Fat Mass, Weight Loss, Body Circumference Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Erchonia Corporation
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 19 Oct 2021 (actual)
- Results
- Posted 3 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to evaluate the effectiveness of Low Level Laser Therapy in combination with Lifestyle Modifications in helping people reduce the extra weight and size in the central body region
Detailed description
Subjects will undergo Low Level Laser Therapy or Sham (placebo) treatments while incorporating lifestyle modifications through of wellness coaching.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized clinical trial where subjects are placed into 2 different study arms. Subjects randomized to 2 groups that either receive Low Level Laser therapy with lifestyle modifications or Sham (placebo) with Lifestyle Modifications.
| Arm | Type | Receives |
|---|---|---|
| Group 1 - LLLT | Active comparator | Device: Low Level Laser TherapySubject receive Laser treatments and Lifestyle Modifications |
| Group 2 - SHAM | Sham comparator | Other: Sham (placebo)Subject receives Sham Laser treatments and Lifestyle Modifications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- have a BMI 25-39.9 kg/m2
- be able to participate fully in all aspects of the study; and
- have understood and signed study informed consent
Key exclusion criteria (24 listed)
- have used weight loss medications or participated in a weight loss program within the past 30 days
- are currently taking medications or supplements known to affect weight, such as insulin or sulfonylurea, prednisone or garcinia cambrogia
- have had weight fluctuations of 5 pounds or more in the past month
- have an implanted device (including pacemaker or lap band) in the targeted area of LLLT
- have a known active eating disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Level Laser TherapyNon-surgical cosmetic treatment which can be used by individuals intending to reduce size of the mid-section | Device | Group 1 - LLLT |
| Sham (placebo)Use of sham (placebo) option | Other | Group 2 - SHAM |
Primary outcome
Change in Fat Mass From Baseline to 6 Weeks
Time frame: 6 weeks
The change in fat mass from baseline to the end of treatments at 6 weeks
Change in Waist Circumference From Baseline to 6 Weeks
Time frame: 6 weeks
The change in waist circumference from baseline to the end of treatments at 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivana T Croghan, PhD principal investigator
Professor of Medicine, College of Medicine
Ryan T Hurt, MD, PhD study director
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Level Laser Therapy in people with Overweight and Obesity and Weight Loss, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fat Mass From Baseline to 6 Weeks (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.