An interventional study of Care as Usual Group and Sham Group in Obesity, Body Weight and Fat Burn, sponsored by IR Technology, LLC. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-15.
Sponsored by IR Technology, LLC · Not applicable, Interventional, and Treatment
The trial was designed to provide empirical evidence with which to compare the efficacy and safety of the invisa-RED Technology Elite Low-level Laser Therapy (LLLT) device with a sham device as a placebo, when both are used in the treatment of individuals to reduce body fat and improve body aesthetics. At the conclusion of the trial; the change in body fat percentage, the change in total body fat in pounds, and total inches lost of the two groups were statistically analyzed to determine the efficacy of the invisa-RED Technology Elite when used for body fat (adipose tissue) loss and/or aesthetics therapy.
The trial was designed to prove the efficacy and safety of the invisa-RED Technology Elite Low-level Laser Therapy (LLLT) device. The trial compared results between two groups; the first group was treated using a fully functional invisa-RED Technology Elite device; this group was designated the Usual Care Group.
The second, a control group, was treated utilizing a nonfunctional invisa-RED Technology Elite device; this group is referred to as the Sham Group.The sham device consisted of an invisa-RED Technology Elite device that will appear to operate as the Usual Care Group device to the operator and participants, but the laser diodes will be disabled and will receive no power providing a placebo effect. If staff or a participant questions the efficacy of the sham device, an assertion may be made that only a near infrared, non-visible frequency of light, is being employed.
The trial was conducted employing a double blind study methodology; participants were randomly assigned to each group through a drawing, neither participants nor clinicians knew to which trial group they were assigned. To ensure the double blind; treatment for the two groups occurred separately using clinicians exclusive to each group.
A simplified weight loss protocol was employed based on the "Consultation Protocol" from the invisa-Red Training Manual. All study participants received nine (9) therapy sessions of 20 minutes each; power settings were based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 was used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 was employed. At the conclusion of the nine (9) therapy sessions; the change in weight of body fat, body fat as a percentage of total body weight, and inches lost of the two groups were statistically analyzed to determine the efficacy of the invisa-RED Technology Elite as a therapy to reduce adipose tissue. The occurrence of any medical errors were documented and included in the statistical analysis.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 39 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →IR Technology, LLC is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Any healthy individual.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A randomly selected group of 20 participants who received treatment per the prescribed trial protocol using a fully functional invisa-RED Technology Elite device. Treatment protocol was as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular LLLT protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.
Device: Care as Usual Group
A randomly selected group of 20 participants who will receive treatment per the prescribed trial protocol using a non functional invisa-RED Technology Elite device. (The sham device will be disabled and will deliver no low laser light energy during therapy.) Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.
Device: Sham Group
Each participant randomly assigned to the "Care As Usual Group" will undergo nine therapy sessions over three weeks using a fully functioning invisa-RED Technology Elite device.
Each participant randomly assigned to the "Sham Group" will undergo nine therapy sessions over three weeks using a non functioning invisa-RED Technology Elite device.
Change in Body Fat Percentage
Measured change in body fat as a percentage of total weight.
Time frame: In order to determine change over time, body fat as a percentage of body weight will be measured before any treatment at first therapy session and measured again for comparison at the end of three weeks therapy.
Change in Body Circumference Measurements
The prescribed body circumference measurements of the chest, right arm, upper-waist, mid-waist, hips, and right thigh are summed for each participant and recorded.
Time frame: In order to determine change over time, the prescribed body measurements will be summed for each participant and recorded before any treatment at first therapy session and recorded again for comparison at the end of three weeks therapy.
Change in Weight of Body Fat
The percentage of body fat for each participant was measured using Bioelectrical Impedance Analysis (BIA). That percentage is then multiplied by the total body weight of the participant in order to calculate the weight in pounds of the participants body fat.
Time frame: In order to determine change over time, each participants body fat weight will be calculated before any treatment at the first therapy session and calculated again to determine if there exists any change at the end of three weeks therapy.
The Trial recruitment period had a start date of January 14th and ended on January 19th 2019. (A total of 6 days) All participant recruitment and interviews were conducted at the Cross Chiropractic Center in Hixson, TN.
| Milestone | Care as Usual Group | Sham Group |
|---|---|---|
| Started | 20 | 19 |
| Completed | 18 | 15 |
| Not completed | 2 | 4 |
| Withdrew: Lack of efficacy, withdrawal by subject | 0 | 4 |
| Withdrew: Unable to measure body fat percentage | 2 | 0 |
Measured change in body fat as a percentage of total weight.
| Percentage of Body Fat | Care as Usual Group | Sham Group |
|---|---|---|
| Change in Body Fat Percentage | -1.7556 (-2.4273 to -1.0838) | 0.280 (-.1194 to 0.6794) |
The prescribed body circumference measurements of the chest, right arm, upper-waist, mid-waist, hips, and right thigh are summed for each participant and recorded.
| Inches | Care as Usual Group | Sham Group |
|---|---|---|
| Change in Body Circumference Measurements | -10.162500 (-12.1930 to -8.1319) | -3.100000 (-5.8958 to -.304128) |
The percentage of body fat for each participant was measured using Bioelectrical Impedance Analysis (BIA). That percentage is then multiplied by the total body weight of the participant in order to calculate the weight in pounds of the participants body fat.
| Pounds | Care as Usual Group | Sham Group |
|---|---|---|
| Change in Weight of Body Fat | -4.5183 ± 3.42558 | -.0480 ± 2.35970 |
Collected over Three weeks concurrent with clinical trial.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Care as Usual Group | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Sham Group | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Age, Continuous(years) | Care as Usual Group | Sham Group | Total |
|---|---|---|---|
| Mean | 48.6 ± 9.22 | 50.6 ± 13.30 | 49.46 ± 11.01 |
| Sex: Female, Male(Participants) | Care as Usual Group | Sham Group | Total |
|---|---|---|---|
| Female | 19 | 16 | 35 |
| Male | 1 | 3 | 4 |
| Race and Ethnicity Not Collected(Participants) | Care as Usual Group | Sham Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Care as Usual Group | Sham Group | Total |
|---|---|---|---|
| United States | 20 | 19 | 39 |
| Percentage Body Fat(Percent Body Fat) | Care as Usual Group | Sham Group | Total |
|---|---|---|---|
| Mean | 40.38 ± 6.25 | 39.63 ± 6.90 | 40.04 ± 6.46 |
| Body Circumference Measurements(Inches) | Care as Usual Group | Sham Group | Total |
|---|---|---|---|
| Mean | 225.19 ± 30.64 | 222.58 ± 24.83 | 224.07 ± 27.93 |
| Weight of Body Fat(Pounds) | Care as Usual Group | Sham Group | Total |
|---|---|---|---|
| Mean | 82.80 ± 28.12 | 85.81 ± 26.06 | 84.17 ± 26.83 |
PDFs hosted by the registry, ClinicalTrials.gov.
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IR Technology, LLC