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| Name | Class |
|---|---|
| Natreon, Inc. | INDUSTRY |
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This study will demonstrate the ability of the oral supplement, PrimaVie® to improve skin microperfusion, hydration, elasticity and barrier function. 45 females will be enrolled in 1 of 3 arms where they will receive either 125 mg PrimaVie, 250 mg PrimaVie or placebo (control) to take twice daily for 14 weeks.
Subjects will be assessed based on they type of Fitzpatrick skin type they have, will be return for a total of 6 study visits over 14 weeks where the following research activities will take place through the course of the study: medical/dietary history, medications will be recorded, supplement randomization based on one of the three arms will occur at study visit 1, and distribution of the study product will occur at all study visits, supplement tolerabiltity assessment, investigator and subject appearance assessment, photography of the face (left, right and front) will be taken, non-invasive assessments including Trans-epidermal Water Loss, hydration, elasticity, laser speckle perfusion, a skin biopsy of left inner upper arm (only at study visits 2 and 6), adverse event review, and supplement count/compliance review.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | 15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks. |
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| Arm 2 | Active Comparator | 15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks. |
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| Arm 3 | Placebo Comparator | 15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrimaVie Herbal Supplement 125 | Dietary Supplement | 125 mg to take BID for 14 weeks in Arm 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Non-invasive Skin Assessment of Skin Microperfusion | To see the improvement in noninvasive skin assessment of objective measurements such as skin microperfusion (laser speckle contrast imaging) (scale Pu). An increase in PU means improved perfusion of the skin. | 14 weeks after oral supplementation |
| Improvement in Non-invasive Skin Assessment of Hydration | To see the improvement in noninvasive skin assessment of objective measurements such as skin hydration using the DermaLab Combo Series (unit of micro-Siemens uS), which are arbitrary. An increase in uS means improved skin hydration and improved skin barrier function. | 14 weeks after oral supplementation |
| Improvement in Non-invasive Skin Assessment of Elasticity | To see the improvement in noninvasive skin assessment of objective measurements such as skin elasticity using the DermaLab Combo Series (mega Pascal mPa). An increase in mPA means worsening of skin elasticity. | 14 weeks after oral supplementation |
| Improvement in Non-invasive Skin Assessment of Barrier Function | To see the improvement in noninvasive skin assessment of objective measurements such as barrier function using Trans-Epidermal Water Loss (TEWL) using the DermaLab Combo Series (g/m2/h). An increase in these units indicates a worsening of TEWL, and reduction of the barrier function of the skin. | 14 weeks after oral supplementation |
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| Measure | Description | Time Frame |
|---|---|---|
| Gene Chip Analysis- ITGA5 - Integrin Subunit Alpha 5 | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80 AU. The gene of interest examined here is ITGA5 - Integrin Subunit Alpha 5. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of the ITGA5 are predicted to be associated with improved outcomes related to extracellular matrix production. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. |
Inclusion Criteria:
Exclusion Criteria:
Any dermatological disorder that may interfere with the accurate evaluation of the subject's skin.
Subjects who are pregnant, breast feeding, or planning a pregnancy.
Clinically significant unstable medical disorders.
History of, diabetes, heart or kidney disease
History of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study.
Any skin disease in the area of the upper inner arm where the biopsies will be obtained.
Currently taking the following medications:
Prisoners
Males
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| Name | Affiliation | Role |
|---|---|---|
| Gayle M Gordillo, M.D. | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OSU Hospital East | Columbus | Ohio | 43205 | United States | ||
| Davis Heart and Lung Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31161927 | Derived | Das A, S El Masry M, Gnyawali SC, Ghatak S, Singh K, Stewart R, Lewis M, Saha A, Gordillo G, Khanna S. Skin Transcriptome of Middle-Aged Women Supplemented With Natural Herbo-mineral Shilajit Shows Induction of Microvascular and Extracellular Matrix Mechanisms. J Am Coll Nutr. 2019 Aug;38(6):526-536. doi: 10.1080/07315724.2018.1564088. Epub 2019 Jun 4. |
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Subjects using medications for cardiovascular disease-related disorders (hydrochlororthiazide, aspirin, steroids, ACE inhibitors, beta-blockers and statins) were excluded from the study. Pregnant females and individuals being treatment for being immunocompromised were also not included.
Study protocols and materials were approved by the Western Institutional Review Board. Written informed consent was collected from all subjects before participation. Female subjects aged between 30 and 65 were included in the study. Supplement randomization was done at study visit 1 and distribution of the supplements were done at each study visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | PrimaVie Herbal Supplement 125 mg | 15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks. PrimaVie Herbal Supplement 125: 125 mg to take BID for 14 weeks in Arm 1 |
| FG001 | Arm 2- PrimaVie Herbal Supplement 250 mg | 15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks. PrimaVie Herbal Supplement 250: 250 mg to take BID for 14 weeks in Arm 2 |
| FG002 | Arm 3- Placebo | 15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks. Placebo: Placebo supplement to take BID for 14 weeks in Arm 3 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1- PrimaVie Herbal Supplement 125 | 15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks. PrimaVie Herbal Supplement 125: 125 mg to take BID for 14 weeks in Arm 1 |
| BG001 | Arm 2- PrimaVie Herbal Supplement 250 mg |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Improvement in Non-invasive Skin Assessment of Skin Microperfusion | To see the improvement in noninvasive skin assessment of objective measurements such as skin microperfusion (laser speckle contrast imaging) (scale Pu). An increase in PU means improved perfusion of the skin. | Posted | Mean | Standard Deviation | Perfusion Units (PU) | 14 weeks after oral supplementation |
|
14 weeks
There were no adverse events reported in any participants for the duration of the study.
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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 | Arm 1 | 15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks. PrimaVie Herbal Supplement 125: 125 mg to take BID for 14 weeks in Arm 1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gayle Gordillo, MD | Indiana University | 3172782720 | Amym@iu.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 | Jan 8, 2016 | Mar 3, 2026 | Prot_SAP_000.pdf |
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| PrimaVie Herbal Supplement 250 | Dietary Supplement | 250 mg to take BID for 14 weeks in Arm 2 |
|
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| Placebo | Drug | Placebo supplement to take BID for 14 weeks in Arm 3 |
|
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| 14 weeks |
| Gene Chip Analysis: JAM3 - Junctional Adhesion Molecule 3 | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80 AU. The gene of interest examined here is JAM3- Junctional Adhesion Molecule 3. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of the JAM3 are predicted to be associated with improved outcomes related to extracellular matrix production. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | 14 weeks |
| Gene Chip Analysis - LGALS1 - Galectin 1 | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU. The gene of interest examined here is LGALS1 - Galectin 1. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of LGALS1- Galectin 1 are predicted to be associated with improved outcomes related to extracellular matrix production. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | 14 weeks |
| Gene Chip Analysis - LOX- Lysyl Oxidase | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU. The gene of interest examined here is LOX- Lysyl Oxidase. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of LOX- Lysyl Oxidase are predicted to be associated with improved outcomes related to extracellular matrix production. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | 14 weeks |
| Gene Chip Analysis - MMP2 - Matrix Metallopeptidase 2 | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU. The gene of interest examined here is MMP2- Matrix Metallopeptidase 2. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of MMP2- Matrix Metallopeptidase 2 are predicted to be associated with improved outcomes related to extracellular matrix production. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | 14 weeks |
| Gene Chip Analysis - PDGFRB - Platelet-Derived Growth Factor Receptor Beta | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU. The gene of interest examined here is PDGFRB- Platelet-Derived Growth Factor Receptor Beta. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of PDGFRB- Platelet-Derived Growth Factor Receptor Beta may be associated with better blood flow in tissue. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | 14 weeks |
| Gene Chip Analysis - PRKG1 - Protein Kinase, cGMP-Dependent, Type I | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU. The gene of interest examined here is PRKG1- Protein Kinase, cGMP-Dependent, Type I. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of PRKG1- Protein Kinase, cGMP-Dependent, Type I may be associated with better blood flow in tissue. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | 14 weeks |
| Gene Chip Analysis - SERPINE1 - Serpin Family E Member 1 (Plasminogen Activator Inhibitor-1, PAI-1) | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU. The gene of interest examined here is SERPINE1- Serpin Family E Member 1 (Plasminogen Activator Inhibitor-1, PAI-1). Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of SERPINE1- Serpin Family E Member 1 (Plasminogen Activator Inhibitor-1, PAI-1) may be associated with better blood flow in tissue. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | 14 weeks |
| Gene Chip Analysis - SPARC - Secreted Protein Acidic and Cysteine Rich | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU. The gene of interest examined here is SPARC- Secreted Protein Acidic and Cysteine Rich. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of SPARC- Secreted Protein Acidic and Cysteine Rich may be associated with better blood flow in tissue. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | 14 weeks |
| Gene Chip Analysis - THBS2 - Thrombospondin 2 | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU. The gene of interest examined here is THBS2- Thrombospondin 2. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of THBS2- Thrombospondin 2 are predicted to be associated with improved outcomes related to extracellular matrix production. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | 14 weeks |
| Gene Chip Analysis - TIMP1 - Tissue Inhibitor of Metalloproteinases 1 | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU. The gene of interest examined here is TIMP1 - Tissue Inhibitor of Metalloproteinases 1. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of TIMP1 - Tissue Inhibitor of Metalloproteinases 1 are predicted to be associated with improved outcomes related to extracellular matrix production. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | 14 weeks |
| Gene Chip Analysis - TIMP2 - Tissue Inhibitor of Metalloproteinases 2 | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU. The gene of interest examined here is TIMP2 - Tissue Inhibitor of Metalloproteinases 2. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of TIMP2 - Tissue Inhibitor of Metalloproteinases 2 are predicted to be associated with improved outcomes related to extracellular matrix production. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | 14 weeks |
| Gene Chip Analysis - TNN - Tenascin N | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The gene of interest examined here is TNN- Tenascin N. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of TNN- Tenascin N are predicted to be associated with improved outcomes related to extracellular matrix production. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | 14 weeks |
| Gene Chip Analysis - RECK - Reversion-Inducing Cysteine-Rich Protein With Kazal Motifs | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The gene of interest examined here is RECK - Reversion-Inducing Cysteine-Rich Protein with Kazal Motifs. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of RECK - Reversion-Inducing Cysteine-Rich Protein with Kazal Motifsare predicted to be associated with improved outcomes related to extracellular matrix production. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | 14 weeks |
| Gene Chip Analysis - COL1A1 - Collagen Type I Alpha 1 Chain | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU. The gene of interest examined here is COL1A1 - Collagen Type I Alpha 1 Chain. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of COL1A1 - Collagen Type I Alpha 1 Chain are predicted to be associated with improved outcomes related to extracellular matrix production. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | 14 weeks |
| Gene Chip Analysis - COL5A2 - Collagen Type V Alpha 2 Chain | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU. The gene of interest examined here is COL5A2 - Collagen Type V Alpha 2 Chain. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of COL5A2 - Collagen Type V Alpha 2 Chain are predicted to be associated with improved outcomes related to extracellular matrix production. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | 14 weeks |
| Gene Chip Analysis - COL14A1 - Collagen Type XIV Alpha 1 Chain | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU. The gene of interest examined here is COL14A1 - Collagen Type XIV Alpha 1 Chain. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of COL14A1 - Collagen Type XIV Alpha 1 Chain are predicted to be associated with improved outcomes related to extracellular matrix production. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | 14 weeks |
| Columbus |
| Ohio |
| 43210 |
| United States |
| Martha Morehouse Medical Plaza 2050 Kenny Road | Columbus | Ohio | 43221 | United States |
| Withdrawal by Subject |
|
15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks. PrimaVie Herbal Supplement 250: 250 mg to take BID for 14 weeks in Arm 2 |
| BG002 | Arm 3- Placebo | 15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks. Placebo: Placebo supplement to take BID for 14 weeks in Arm 3 |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG002 | Arm 3- Placebo | 15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks. Placebo: Placebo supplement to take BID for 14 weeks in Arm 3 |
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| Primary | Improvement in Non-invasive Skin Assessment of Hydration | To see the improvement in noninvasive skin assessment of objective measurements such as skin hydration using the DermaLab Combo Series (unit of micro-Siemens uS), which are arbitrary. An increase in uS means improved skin hydration and improved skin barrier function. | Posted | Mean | Standard Deviation | Hydration Units (uS/arbitrary units) | 14 weeks after oral supplementation |
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| Primary | Improvement in Non-invasive Skin Assessment of Elasticity | To see the improvement in noninvasive skin assessment of objective measurements such as skin elasticity using the DermaLab Combo Series (mega Pascal mPa). An increase in mPA means worsening of skin elasticity. | Posted | Mean | Standard Deviation | Young's modulus (Mpa) | 14 weeks after oral supplementation |
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| Primary | Improvement in Non-invasive Skin Assessment of Barrier Function | To see the improvement in noninvasive skin assessment of objective measurements such as barrier function using Trans-Epidermal Water Loss (TEWL) using the DermaLab Combo Series (g/m2/h). An increase in these units indicates a worsening of TEWL, and reduction of the barrier function of the skin. | Posted | Mean | Standard Deviation | TEWL Units = g·m-²·h-¹ | 14 weeks after oral supplementation |
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| Other Pre-specified | Gene Chip Analysis- ITGA5 - Integrin Subunit Alpha 5 | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80 AU. The gene of interest examined here is ITGA5 - Integrin Subunit Alpha 5. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of the ITGA5 are predicted to be associated with improved outcomes related to extracellular matrix production. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed. | Posted | Mean | Standard Deviation | Arbitrary Units | 14 weeks |
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| Other Pre-specified | Gene Chip Analysis: JAM3 - Junctional Adhesion Molecule 3 | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80 AU. The gene of interest examined here is JAM3- Junctional Adhesion Molecule 3. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of the JAM3 are predicted to be associated with improved outcomes related to extracellular matrix production. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed. | Posted | Mean | Standard Deviation | Arbitrary Units | 14 weeks |
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| Other Pre-specified | Gene Chip Analysis - LGALS1 - Galectin 1 | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU. The gene of interest examined here is LGALS1 - Galectin 1. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of LGALS1- Galectin 1 are predicted to be associated with improved outcomes related to extracellular matrix production. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed. | Posted | Mean | Standard Deviation | Arbitrary Units | 14 weeks |
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| Other Pre-specified | Gene Chip Analysis - LOX- Lysyl Oxidase | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU. The gene of interest examined here is LOX- Lysyl Oxidase. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of LOX- Lysyl Oxidase are predicted to be associated with improved outcomes related to extracellular matrix production. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed. | Posted | Mean | Standard Deviation | Arbitrary Units | 14 weeks |
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| Other Pre-specified | Gene Chip Analysis - MMP2 - Matrix Metallopeptidase 2 | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU. The gene of interest examined here is MMP2- Matrix Metallopeptidase 2. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of MMP2- Matrix Metallopeptidase 2 are predicted to be associated with improved outcomes related to extracellular matrix production. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | Posted | Mean | Standard Deviation | Arbitrary Units | 14 weeks |
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| Other Pre-specified | Gene Chip Analysis - PDGFRB - Platelet-Derived Growth Factor Receptor Beta | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU. The gene of interest examined here is PDGFRB- Platelet-Derived Growth Factor Receptor Beta. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of PDGFRB- Platelet-Derived Growth Factor Receptor Beta may be associated with better blood flow in tissue. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed. | Posted | Mean | Standard Deviation | Arbitrary Units | 14 weeks |
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| Other Pre-specified | Gene Chip Analysis - PRKG1 - Protein Kinase, cGMP-Dependent, Type I | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU. The gene of interest examined here is PRKG1- Protein Kinase, cGMP-Dependent, Type I. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of PRKG1- Protein Kinase, cGMP-Dependent, Type I may be associated with better blood flow in tissue. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed. | Posted | Mean | Standard Deviation | Arbitrary Units | 14 weeks |
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| Other Pre-specified | Gene Chip Analysis - SERPINE1 - Serpin Family E Member 1 (Plasminogen Activator Inhibitor-1, PAI-1) | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU. The gene of interest examined here is SERPINE1- Serpin Family E Member 1 (Plasminogen Activator Inhibitor-1, PAI-1). Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of SERPINE1- Serpin Family E Member 1 (Plasminogen Activator Inhibitor-1, PAI-1) may be associated with better blood flow in tissue. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed. | Posted | Mean | Standard Deviation | Arbitrary Units | 14 weeks |
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| Other Pre-specified | Gene Chip Analysis - SPARC - Secreted Protein Acidic and Cysteine Rich | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU. The gene of interest examined here is SPARC- Secreted Protein Acidic and Cysteine Rich. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of SPARC- Secreted Protein Acidic and Cysteine Rich may be associated with better blood flow in tissue. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed. | Posted | Mean | Standard Deviation | Arbitrary Units | 14 weeks |
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| Other Pre-specified | Gene Chip Analysis - THBS2 - Thrombospondin 2 | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU. The gene of interest examined here is THBS2- Thrombospondin 2. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of THBS2- Thrombospondin 2 are predicted to be associated with improved outcomes related to extracellular matrix production. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed. | Posted | Mean | Standard Deviation | Arbitrary Units | 14 weeks |
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| Other Pre-specified | Gene Chip Analysis - TIMP1 - Tissue Inhibitor of Metalloproteinases 1 | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU. The gene of interest examined here is TIMP1 - Tissue Inhibitor of Metalloproteinases 1. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of TIMP1 - Tissue Inhibitor of Metalloproteinases 1 are predicted to be associated with improved outcomes related to extracellular matrix production. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed. | Posted | Mean | Standard Deviation | Arbitrary Units | 14 weeks |
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| Other Pre-specified | Gene Chip Analysis - TIMP2 - Tissue Inhibitor of Metalloproteinases 2 | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU. The gene of interest examined here is TIMP2 - Tissue Inhibitor of Metalloproteinases 2. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of TIMP2 - Tissue Inhibitor of Metalloproteinases 2 are predicted to be associated with improved outcomes related to extracellular matrix production. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed. | Posted | Mean | Standard Deviation | Arbitrary Units | 14 weeks |
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| Other Pre-specified | Gene Chip Analysis - TNN - Tenascin N | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The gene of interest examined here is TNN- Tenascin N. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of TNN- Tenascin N are predicted to be associated with improved outcomes related to extracellular matrix production. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed. | Posted | Mean | Standard Deviation | Arbitrary Units | 14 weeks |
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| Other Pre-specified | Gene Chip Analysis - RECK - Reversion-Inducing Cysteine-Rich Protein With Kazal Motifs | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The gene of interest examined here is RECK - Reversion-Inducing Cysteine-Rich Protein with Kazal Motifs. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of RECK - Reversion-Inducing Cysteine-Rich Protein with Kazal Motifsare predicted to be associated with improved outcomes related to extracellular matrix production. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed. | Posted | Mean | Standard Deviation | Arbitrary Units | 14 weeks |
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| Other Pre-specified | Gene Chip Analysis - COL1A1 - Collagen Type I Alpha 1 Chain | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU. The gene of interest examined here is COL1A1 - Collagen Type I Alpha 1 Chain. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of COL1A1 - Collagen Type I Alpha 1 Chain are predicted to be associated with improved outcomes related to extracellular matrix production. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed. | Posted | Mean | Standard Deviation | Arbitrary Units | 14 weeks |
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| Other Pre-specified | Gene Chip Analysis - COL5A2 - Collagen Type V Alpha 2 Chain | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU. The gene of interest examined here is COL5A2 - Collagen Type V Alpha 2 Chain. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of COL5A2 - Collagen Type V Alpha 2 Chain are predicted to be associated with improved outcomes related to extracellular matrix production. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed. | Posted | Mean | Standard Deviation | Arbitrary Units | 14 weeks |
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| Other Pre-specified | Gene Chip Analysis - COL14A1 - Collagen Type XIV Alpha 1 Chain | We selected 17 genes of interest, and examined the difference in their expression in each interventional arm, compared to the placebo group. The results are listed in Arbitrary Units (AU), with each AU indicating an relative increase or decrease in gene expression compared to the control (reference comparator). The range is 0.0 to 80AU. The gene of interest examined here is COL14A1 - Collagen Type XIV Alpha 1 Chain. Gene expression values cannot be directly interpreted as indicative of better or worse outcomes. However, based on the literature review, higher expression levels of COL14A1 - Collagen Type XIV Alpha 1 Chain are predicted to be associated with improved outcomes related to extracellular matrix production. For Genechip analysis, the differentially expressed genes were identified using a two-class t test where significance level was set at p < 0.05 with Benjamini-Hochberg correction for false discovery rate. | RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed. | Posted | Mean | Standard Deviation | Arbitrary Units | 14 weeks |
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| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Arm 2 | 15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks. PrimaVie Herbal Supplement 250: 250 mg to take BID for 14 weeks in Arm 2 | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | Arm 3 | 15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks. Placebo: Placebo supplement to take BID for 14 weeks in Arm 3 | 0 | 15 | 0 | 15 | 0 | 15 |
Not provided
Not provided
|
Statistical significance is defined as p less than or equal to 0.05. A T-test was completed comparing hydration in Arm 1 (125mg PrimaVie) at Visit 1 and Visit 6 (14 weeks later). |
| t-test, 2 sided |
| 0.46 |
P=0.46 |
| Equivalence |
This analysis represents an equivalence analysis. |
| Statistical significance is defined as p less than or equal to 0.05. A T-test was completed comparing hydration in Arm 2 (250mg PrimaVie) at Visit 1 and Visit 6 (14 weeks later). | t-test, 2 sided | 0.61 | P=0.61 | Equivalence | This analysis represents an equivalence analysis. |
| Statistical significance is defined as p less than or equal to 0.05. A T-test was completed comparing hydration in Arm 2 (250 mg PrimaVie) vs Arm 3 (Placebo) at Visit 6 (14 weeks after study start). | t-test, 2 sided | 0.46 | P= 0.46 | Equivalence | This analysis represents an equivalence analysis. |
|
Statistical significance is defined as p less than or equal to 0.05. A T-test was completed comparing elasticity in Arm 1 (125mg PrimaVie) at Visit 1 and Visit 6 (14 weeks later). |
| t-test, 2 sided |
| 0.96 |
P=0.96 |
| Equivalence |
This analysis represents an equivalence analysis. |
| Statistical significance is defined as p less than or equal to 0.05. A T-test was completed comparing hydration in Arm 2 (250mg PrimaVie) at Visit 1 and Visit 6 (14 weeks later). | t-test, 2 sided | 0.54 | P=0.54 | Equivalence | This analysis represents an equivalence analysis. |
| Statistical significance is defined as p less than or equal to 0.05. A T-test was completed comparing hydration in Arm 2 (125mg PrimaVie) vs Arm 3 (Placebo) at Visit 6 (14 weeks after study start). | t-test, 2 sided | 0.56 | P=0.56 | Equivalence | This analysis represents an equivalence analysis. |
|
Statistical significance is defined as p less than or equal to 0.05. A T-test was completed comparing skin barrier function in Arm 1 (125mg PrimaVie) at Visit 1 and Visit 6 (14 weeks later). |
| t-test, 2 sided |
| 0.19 |
P=0.19 |
| Equivalence |
This analysis represents an equivalence analysis. |
| Statistical significance is defined as p less than or equal to 0.05.A T-test was completed comparing skin barrier function in Arm 2 (250mg PrimaVie) at Visit 1 and Visit 6 (14 weeks later). | t-test, 2 sided | 0.60 | P=0.60 | Equivalence | This analysis represents an equivalence analysis. |
| Statistical significance is defined as p less than or equal to 0.05. A T-test was completed comparing skin barrier function in Arm 2 (250mg PrimaVie) vs Arm 3 (Placebo) at Visit 6 (14 weeks after study start). | t-test, 2 sided | 0.55 | P=0.55 | Equivalence | This analysis represents an equivalence analysis. |
| t-test, 2 sided |
| 0.79 |
No adjustment for multiple comparisons. The threshold of significance is P< 0.05. |
| Equivalence |
This analysis represents an equivalence analysis. The primary objective was to determine whether Natreon PrimaVie supplementation demonstrated superiority over standard of care. |
| t-test, 2 sided |
| 0.02 |
No adjustments. The threshold for statistical significance is P <0.05. |
| Equivalence |
This analysis represents an equivalence analysis. The primary objective was to determine whether Natreon PrimaVie supplementation demonstrated superiority over standard of care. |
| t-test, 2 sided |
| 0.67 |
No adjustment for multiple comparisons. The threshold of significance is P< 0.05. |
| Equivalence |
This analysis represents an equivalence analysis. The primary objective was to determine whether Natreon PrimaVie supplementation demonstrated superiority over standard of care. |
| t-test, 2 sided |
| 0.09 |
No adjustment for multiple comparisons. The threshold of significance is P< 0.05. |
| Equivalence |
This analysis represents an equivalence analysis. The primary objective was to determine whether Natreon PrimaVie supplementation demonstrated superiority over standard of care. |
| t-test, 2 sided |
| 0.55 |
No adjustment for multiple comparisons. The threshold of significance is P< 0.05. |
| Equivalence |
This analysis represents an equivalence analysis. The primary objective was to determine whether Natreon PrimaVie supplementation demonstrated superiority over standard of care. |
| t-test, 2 sided |
| 0.95 |
No adjustment for multiple comparisons. The threshold of significance is P< 0.05. |
| Equivalence |
This analysis represents an equivalence analysis. The primary objective was to determine whether Natreon PrimaVie supplementation demonstrated superiority over standard of care. |
| t-test, 2 sided |
| 0.68 |
No adjustment for multiple comparisons. The threshold of significance is P< 0.05. |
| Equivalence |
This analysis represents an equivalence analysis. The primary objective was to determine whether Natreon PrimaVie supplementation demonstrated superiority over standard of care. |
| 0.91 |
No adjustment for multiple comparisons. The threshold of significance is P< 0.05. |
| Equivalence |
This analysis represents an equivalence analysis. The primary objective was to determine whether Natreon PrimaVie supplementation demonstrated superiority over standard of care. |
| t-test, 2 sided |
| 0.91 |
No adjustment for multiple comparisons. The threshold of significance is P< 0.05. |
| Equivalence |
This analysis represents an equivalence analysis. The primary objective was to determine whether Natreon PrimaVie supplementation demonstrated superiority over standard of care. |
| t-test, 2 sided |
| 0.68 |
This analysis represents an equivalence analysis. The primary objective was to determine whether Natreon PrimaVie supplementation demonstrated superiority over standard of care. |
| Equivalence |
This analysis represents an equivalence analysis. The primary objective was to determine whether Natreon PrimaVie supplementation demonstrated superiority over standard of care. |
| t-test, 2 sided |
| 0.10 |
No adjustment for multiple comparisons. The threshold of significance is P< 0.05. |
| Equivalence |
This analysis represents an equivalence analysis. The primary objective was to determine whether Natreon PrimaVie supplementation demonstrated superiority over standard of care. |
| t-test, 2 sided |
| 0.12 |
No adjustment for multiple comparisons. The threshold of significance is P< 0.05. |
| Equivalence |
This analysis represents an equivalence analysis. The primary objective was to determine whether Natreon PrimaVie supplementation demonstrated superiority over standard of care. |
| t-test, 2 sided |
| 0.37 |
No adjustment for multiple comparisons. The threshold of significance is P< 0.05. |
| Equivalence |
This analysis represents an equivalence analysis. The primary objective was to determine whether Natreon PrimaVie supplementation demonstrated superiority over standard of care |
| t-test, 2 sided |
| 0.21 |
No adjustment for multiple comparisons. The threshold of significance is P< 0.05. |
| Equivalence |
This analysis represents an equivalence analysis. The primary objective was to determine whether Natreon PrimaVie supplementation demonstrated superiority over standard of care. |
| t-test, 2 sided |
| 0.69 |
No adjustment for multiple comparisons. The threshold of significance is P< 0.05. |
| Equivalence |
This analysis represents an equivalence analysis. The primary objective was to determine whether Natreon PrimaVie supplementation demonstrated superiority over standard of care. |
| t-test, 2 sided |
| 0.77 |
No adjustment for multiple comparisons. The threshold of significance is P< 0.05. |
| Equivalence |
This analysis represents an equivalence analysis. The primary objective was to determine whether Natreon PrimaVie supplementation demonstrated superiority over standard of care. |
| t-test, 2 sided |
| 0.69 |
No adjustment for multiple comparisons. The threshold of significance is P< 0.05. |
| Equivalence |
This analysis represents an equivalence analysis. The primary objective was to determine whether Natreon PrimaVie supplementation demonstrated superiority over standard of care. |