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| Name | Class |
|---|---|
| Erchonia Corporation | INDUSTRY |
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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
Subjects will undergo Low Level Laser Therapy or Sham (placebo) treatments while incorporating lifestyle modifications through of wellness coaching.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - LLLT | Active Comparator | Subject receive Laser treatments and Lifestyle Modifications |
|
| Group 2 - SHAM | Sham Comparator | Subject receives Sham Laser treatments and Lifestyle Modifications |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Level Laser Therapy | Device | Non-surgical cosmetic treatment which can be used by individuals intending to reduce size of the mid-section |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fat Mass From Baseline to 6 Weeks | The change in fat mass from baseline to the end of treatments at 6 weeks | 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 | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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)
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Ivana T Croghan, PhD | Professor of Medicine, College of Medicine | Principal Investigator |
| Ryan T Hurt, MD, PhD | Mayo Clinic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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Participants will be recruited from the local community through internet postings, Mayo Clinic physician referrals, and word of mouth.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Group 2 - SHAM | Subject receives Sham Laser treatments and Lifestyle Modifications Sham (placebo): Use of sham (placebo) option |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Group 2 - SHAM |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Fat Mass From Baseline to 6 Weeks | The change in fat mass from baseline to the end of treatments at 6 weeks | Analysis population includes subjects with non-missing values for given outcome (change in fat mass at 6 weeks) | Posted | Mean | Standard Deviation | Kg | 6 weeks |
|
AE's were collected over the 6 weeks of the LLLT intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Loose Stool | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ivana Croghan | Mayo Clinic Rochester | 507 284-2511 | gimresearchstudies@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 22, 2024 | Mar 14, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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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.
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Randomization will be set up by a statistician through REDCap, the data collection system utilized for the study.
| Sham (placebo) | Other | Use of sham (placebo) option |
|
| Withdrawal by Subject |
|
| scheduling difficulties |
|
Subject receives Sham Laser treatments and Lifestyle Modifications Sham (placebo): Use of sham (placebo) option |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
|
| Primary | Change in Waist Circumference From Baseline to 6 Weeks | The change in waist circumference from baseline to the end of treatments at 6 weeks | Posted | Mean | Standard Deviation | cm | 6 weeks |
|
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 6 |
| 30 |
| EG001 | Group 2 - SHAM | Subject receives Sham Laser treatments and Lifestyle Modifications Sham (placebo): Use of sham (placebo) option | 0 | 30 | 0 | 30 | 0 | 30 |
| muscle contraction/tingling | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| stomach/gas pain | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |