Abdominal Fat, Adipose Tissue Atrophy, Body Weight, Cellulite, Fat Burn, Obesity
Conditions
Keywords
Adipose, Fat, Aesthetics, Skin, Weight Reduction,
Brief summary
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.
Detailed description
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.
Interventions
DEVICECare as Usual 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.
DEVICESham Group
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.
Sponsors
IR Technology, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
The trial will be conducted employing a double blind study methodology; participants will be randomly assigned to each group through a drawing, neither participants nor clinicians will know to which trial group they are assigned.
Intervention model description
The trial compared results between two groups of participants; the first group was treated using a fully functional device. The second, a control group, was treated utilizing a nonfunctional device. At the conclusion of nine (9) therapy sessions; the change in body fat percentage, the change in body fat in pounds, and inches lost of the two groups will be statistically analyzed to determine the efficacy of the invisa-RED Technology Elite as a weight loss therapy. Any medical errors will be included in the statistical analysis.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Any healthy individual.
Exclusion criteria
* If you are pregnant, trying to get pregnant or nursing laser light therapy should be received only after the end of these conditions. There is no evidence of harm to a an unborn baby however there have been no safety tests either, so for medical legal reasons we recommend never treating areas directly over a developing child. * Individuals with hypertension, light sensitive epilepsy, cancer, heart disease, infectious skin disease, and severe varicose veins should not use this device. * People suffering from infectious and acute disease such as a fever should not use this device. * People who have hemorrhagic disease, vascular ruptures, skin inflammation, or any disease of the skin should not use this device. * People who have immune system dysfunction such as Leukemia, Hemophilia, etc., and light sensitive persons should not use this device. * Individuals with a history of melanoma, raised moles, suspicious lesions, keloid scar formation, or healing problems should not undergo laser light therapy. * Individuals with active infections, open lesions, hives, herpetic lesions, cold sores, or tattoos and permanent make-up in the area of treatment should not undergo laser light therapy. * People who have used isotretinoin (commonly known as Accutane), tetracycline, St. John's Wort, or any photo sensitizing drugs in the last year should not undergo laser light therapy. * Individuals with autoimmune diseases such as Lupus, Scleroderma, or Vitiligo should not undergo laser light therapy. * Individuals who have pacemakers or other electro-stimulation devices surgically implanted should not undergo laser light therapy. * Any insulin dependent individual should consult their physician before undergoing laser light therapy. * All individuals considered vulnerable such as children, pregnant women, nursing home residents or other institutionalized persons, students, employees, fetuses, prisoners, and persons with decisional incapacity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Fat Percentage | 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. | Measured change in body fat as a percentage of total weight. |
| Change in Body Circumference Measurements | 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. | 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. |
| Change in Weight of Body Fat | 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 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Care as Usual Group A randomly selected group of 20 participants who will receive treatment per the prescribed trial protocol using a fully functional invisa-RED Technology Elite device. Treatment protocol is 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.
Care as Usual 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. | 20 |
| Sham 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.
Sham Group: 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. | 19 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy, Withdrawal by Subject | 0 | 4 |
| Overall Study | Unable to measure body fat percentage | 2 | 0 |
Baseline characteristics
| Characteristic | Sham Group | Care as Usual Group | Total |
|---|---|---|---|
| Age, Continuous | 50.6 years STANDARD_DEVIATION 13.3 | 48.6 years STANDARD_DEVIATION 9.22 | 49.46 years STANDARD_DEVIATION 11.01 |
| Body Circumference Measurements | 222.58 Inches STANDARD_DEVIATION 24.83 | 225.19 Inches STANDARD_DEVIATION 30.64 | 224.07 Inches STANDARD_DEVIATION 27.93 |
| Percentage Body Fat | 39.63 Percent Body Fat STANDARD_DEVIATION 6.9 | 40.38 Percent Body Fat STANDARD_DEVIATION 6.25 | 40.04 Percent Body Fat STANDARD_DEVIATION 6.46 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 19 participants | 20 participants | 39 participants |
| Sex: Female, Male Female | 16 Participants | 19 Participants | 35 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 4 Participants |
| Weight of Body Fat | 85.81 Pounds STANDARD_DEVIATION 26.06 | 82.80 Pounds STANDARD_DEVIATION 28.12 | 84.17 Pounds STANDARD_DEVIATION 26.83 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 15 |
| other Total, other adverse events | 0 / 20 | 0 / 15 |
| serious Total, serious adverse events | 0 / 20 | 0 / 15 |
Outcome results
Primary
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.
Population: Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Care as Usual Group | Change in Body Circumference Measurements | -10.162500 Inches |
| Sham Group | Change in Body Circumference Measurements | -3.100000 Inches |
Comparison: Designed as a superiority trial with the aim of establishing whether the intervention was superior or inferior to a placebo in effectiveness as a therapy for change over time in measured body circumference. The null hypothesis states that in the population from where the sample was obtained there was no difference between the intervention (invisa-RED Elite) and placebo groups in the mean change in the primary outcome variable, i.e. measured body circumference.p-value: <0.0195% CI: [3.829, 10.296]t-test, 2 sided
Comparison: A Kolmogorov-Smirnov normality test was used to examine if variables are normally distributed for the population from which the trial groups are drawn.~The null hypothesis is that the distribution of Total Inches Lost or Gained is normal with mean -7.136 and standard deviation 5.796.p-value: 0.2Kolmogorov-Smirnov Test
Comparison: To test that the trial participant's population variances are equal (or exhibit homogeneity of variance), a Levene's Test for Equality of Variance was conducted. It tests the null hypothesis that the population variances are equal (called homogeneity of variance or homoscedasticity). For this test if the resulting p-value of Levene's test is less than .05, the obtained differences in sample variances are unlikely to have occurred based on random sampling from a population with equal variances.p-value: 0.44Levene's Test for Equality of Variance
Primary
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.
Population: 1. Number of Care as Usual Group participants measured was reduced by two morbidly obese participants whose body fat percentage could not be accurately measured.~2. Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Care as Usual Group | Change in Body Fat Percentage | -1.7556 Percentage of Body Fat |
| Sham Group | Change in Body Fat Percentage | 0.280 Percentage of Body Fat |
Comparison: The null hypothesis states that in the population from where the sample was obtained there was no difference between the intervention (invisa-RED Elite) and placebo groups in the mean change in the primary outcome variable, i.e. Change in Body Fat Percentage.p-value: <0.0195% CI: [1.243, 2.828]t-test, 2 sided
Comparison: A single sample Kolmogorov-Smirnov normality test was used to examine if variables are normally distributed for the population from which the trial groups are drawn.~The null hypothesis is that the distribution of Percent of Body Fat Lost or Gained is normal with mean -.83 and standard deviation 1.50218.p-value: 0.2Kolmogorov-Smirnov Test
Comparison: To test that the trial participant's population variances are equal (or exhibit homogeneity of variance), a Levene's Test for Equality of Variance was conducted. It tests the null hypothesis that the population variances are equal (called homogeneity of variance or homoscedasticity). For this test if the resulting p-value of Levene's test is less than .05, the obtained differences in sample variances are unlikely to have occurred based on random sampling from a population with equal variances.p-value: 0.075Levene's Test for Equality of Variance
Primary
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.
Population: 1. Number of Care as Usual Group participants measured was reduced by two morbidly obese participants whose body fat percentage could not be accurately measured.~2. Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Care as Usual Group | Change in Weight of Body Fat | -4.5183 Pounds | Standard Deviation 3.42558 |
| Sham Group | Change in Weight of Body Fat | -.0480 Pounds | Standard Deviation 2.3597 |
Comparison: Designed as a superiority trial with the aim of establishing whether the intervention was superior or inferior to a placebo in effectiveness as a therapy for change in body fat, measured in pounds. The null hypothesis states that in the population from where the sample was obtained there was no difference between the intervention (invisa-RED Elite) and placebo groups in the mean change in the primary outcome variable, i.e. change in pounds of body fat.p-value: <0.0195% CI: [2.3372, 6.6034]t-test, 2 sided
Comparison: A single sample Kolmogorov-Smirnov normality test was used to examine if variables are normally distributed for the population from which the trial groups are drawn.~The null hypothesis is that the distribution of the Weight of Body Fat Lost or Gained is normal with mean -2.49 and standard deviation 3.71209.p-value: 0.2Kolmogorov-Smirnov Test
Comparison: To test that the trial participant's population variances are equal (or exhibit homogeneity of variance), a Levene's Test for Equality of Variance was conducted. It tests the null hypothesis that the population variances are equal (called homogeneity of variance or homoscedasticity). For this test if the resulting p-value of Levene's test is less than .05, the obtained differences in sample variances are unlikely to have occurred based on random sampling from a population with equal variances.p-value: 0.438Levene's Test for Equality of Variance