Trial Outcomes & Findings for Natreon Healthy Skin Study - PrimaVie Supplement (NCT NCT02762032)
NCT ID: NCT02762032
Last Updated: 2026-06-25
Results Overview
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.
COMPLETED
PHASE1
45 participants
14 weeks after oral supplementation
2026-06-25
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
13
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
2
|
Reasons for withdrawal
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
Baseline Characteristics
Natreon Healthy Skin Study - PrimaVie Supplement
Baseline characteristics by cohort
| Measure |
Arm 1- PrimaVie Herbal Supplement 125
n=15 Participants
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
|
Arm 2- PrimaVie Herbal Supplement 250 mg
n=15 Participants
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
|
Arm 3- Placebo
n=15 Participants
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
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=20 Participants
|
15 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
45 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
45.24 years
STANDARD_DEVIATION 7.03 • n=20 Participants
|
38.76 years
STANDARD_DEVIATION 2.00 • n=20 Participants
|
42.47 years
STANDARD_DEVIATION 8.73 • n=40 Participants
|
42.15 years
STANDARD_DEVIATION 8.09 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=20 Participants
|
15 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=20 Participants
|
15 participants
n=20 Participants
|
15 participants
n=40 Participants
|
45 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 weeks after oral supplementationTo 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.
Outcome measures
| Measure |
Arm 1- 125mg PrimaVie
n=13 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks.
|
Arm 2- 250mg PrimaVie
n=13 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks.
|
Arm 3- Placebo
n=13 Participants
15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.
|
|---|---|---|---|
|
Improvement in Non-invasive Skin Assessment of Skin Microperfusion
Visit 1
|
29.71553077 Perfusion Units (PU)
Standard Deviation 2.25361215
|
29.43380385 Perfusion Units (PU)
Standard Deviation 1.054969367
|
29.40696154 Perfusion Units (PU)
Standard Deviation 1.032393275
|
|
Improvement in Non-invasive Skin Assessment of Skin Microperfusion
Visit 6 (14 weeks)
|
30.66594615 Perfusion Units (PU)
Standard Deviation 1.597007714
|
31.57767308 Perfusion Units (PU)
Standard Deviation 0.74005374
|
29.95858462 Perfusion Units (PU)
Standard Deviation 1.061001206
|
PRIMARY outcome
Timeframe: 14 weeks after oral supplementationTo 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.
Outcome measures
| Measure |
Arm 1- 125mg PrimaVie
n=13 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks.
|
Arm 2- 250mg PrimaVie
n=13 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks.
|
Arm 3- Placebo
n=13 Participants
15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.
|
|---|---|---|---|
|
Improvement in Non-invasive Skin Assessment of Hydration
Visit 1
|
206.8173 Hydration Units (uS/arbitrary units)
Standard Deviation 142.7107
|
176.3958 Hydration Units (uS/arbitrary units)
Standard Deviation 38.27346
|
186.3846 Hydration Units (uS/arbitrary units)
Standard Deviation 28.36143
|
|
Improvement in Non-invasive Skin Assessment of Hydration
Visit 6
|
173.1923 Hydration Units (uS/arbitrary units)
Standard Deviation 74.92129
|
185.7292 Hydration Units (uS/arbitrary units)
Standard Deviation 48.93914
|
199.6154 Hydration Units (uS/arbitrary units)
Standard Deviation 43.96407
|
PRIMARY outcome
Timeframe: 14 weeks after oral supplementationTo 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.
Outcome measures
| Measure |
Arm 1- 125mg PrimaVie
n=13 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks.
|
Arm 2- 250mg PrimaVie
n=13 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks.
|
Arm 3- Placebo
n=13 Participants
15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.
|
|---|---|---|---|
|
Improvement in Non-invasive Skin Assessment of Elasticity
Visit 1
|
1.330769 Young's modulus (Mpa)
Standard Deviation 0.449555
|
1.466667 Young's modulus (Mpa)
Standard Deviation 0.62553
|
1.273077 Young's modulus (Mpa)
Standard Deviation 0.367347
|
|
Improvement in Non-invasive Skin Assessment of Elasticity
Visit 6
|
1.338462 Young's modulus (Mpa)
Standard Deviation 0.320094
|
1.308333 Young's modulus (Mpa)
Standard Deviation 0.618588
|
1.184615 Young's modulus (Mpa)
Standard Deviation 0.422732
|
PRIMARY outcome
Timeframe: 14 weeks after oral supplementationTo 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.
Outcome measures
| Measure |
Arm 1- 125mg PrimaVie
n=13 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks.
|
Arm 2- 250mg PrimaVie
n=13 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks.
|
Arm 3- Placebo
n=13 Participants
15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.
|
|---|---|---|---|
|
Improvement in Non-invasive Skin Assessment of Barrier Function
Visit 1
|
14.34808 TEWL Units = g·m-²·h-¹
Standard Deviation 6.117363
|
11.40417 TEWL Units = g·m-²·h-¹
Standard Deviation 3.660397
|
13.54808 TEWL Units = g·m-²·h-¹
Standard Deviation 4.771306
|
|
Improvement in Non-invasive Skin Assessment of Barrier Function
Visit 6
|
11.80962 TEWL Units = g·m-²·h-¹
Standard Deviation 2.6767906
|
12.479167 TEWL Units = g·m-²·h-¹
Standard Deviation 5.9430233
|
13.61923 TEWL Units = g·m-²·h-¹
Standard Deviation 3.195963
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 weeksPopulation: RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed.
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.
Outcome measures
| Measure |
Arm 1- 125mg PrimaVie
n=13 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks.
|
Arm 2- 250mg PrimaVie
n=11 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks.
|
Arm 3- Placebo
n=10 Participants
15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.
|
|---|---|---|---|
|
Gene Chip Analysis- ITGA5 - Integrin Subunit Alpha 5
|
2.0 Arbitrary Units
Standard Deviation 1.7
|
2.0 Arbitrary Units
Standard Deviation 1.5
|
1.4 Arbitrary Units
Standard Deviation 0.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 weeksPopulation: RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed.
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.
Outcome measures
| Measure |
Arm 1- 125mg PrimaVie
n=13 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks.
|
Arm 2- 250mg PrimaVie
n=11 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks.
|
Arm 3- Placebo
n=10 Participants
15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.
|
|---|---|---|---|
|
Gene Chip Analysis: JAM3 - Junctional Adhesion Molecule 3
|
1.7 Arbitrary Units
Standard Deviation 0.5
|
1.2 Arbitrary Units
Standard Deviation 0.6
|
1.2 Arbitrary Units
Standard Deviation 0.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 weeksPopulation: RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed.
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.
Outcome measures
| Measure |
Arm 1- 125mg PrimaVie
n=13 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks.
|
Arm 2- 250mg PrimaVie
n=11 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks.
|
Arm 3- Placebo
n=10 Participants
15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.
|
|---|---|---|---|
|
Gene Chip Analysis - LGALS1 - Galectin 1
|
2.0 Arbitrary Units
Standard Deviation 1.2
|
1.8 Arbitrary Units
Standard Deviation 1.1
|
1.2 Arbitrary Units
Standard Deviation 0.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 weeksPopulation: RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed.
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.
Outcome measures
| Measure |
Arm 1- 125mg PrimaVie
n=13 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks.
|
Arm 2- 250mg PrimaVie
n=11 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks.
|
Arm 3- Placebo
n=10 Participants
15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.
|
|---|---|---|---|
|
Gene Chip Analysis - LOX- Lysyl Oxidase
|
0.0 Arbitrary Units
Standard Deviation 0.0
|
4.3 Arbitrary Units
Standard Deviation 8.4
|
1.3 Arbitrary Units
Standard Deviation 0.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 weeksWe 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.
Outcome measures
| Measure |
Arm 1- 125mg PrimaVie
n=13 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks.
|
Arm 2- 250mg PrimaVie
n=11 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks.
|
Arm 3- Placebo
n=10 Participants
15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.
|
|---|---|---|---|
|
Gene Chip Analysis - MMP2 - Matrix Metallopeptidase 2
|
4.1 Arbitrary Units
Standard Deviation 5.5
|
3.3 Arbitrary Units
Standard Deviation 3.5
|
3.1 Arbitrary Units
Standard Deviation 4.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 weeksPopulation: RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed.
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.
Outcome measures
| Measure |
Arm 1- 125mg PrimaVie
n=13 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks.
|
Arm 2- 250mg PrimaVie
n=11 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks.
|
Arm 3- Placebo
n=10 Participants
15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.
|
|---|---|---|---|
|
Gene Chip Analysis - PDGFRB - Platelet-Derived Growth Factor Receptor Beta
|
2.7 Arbitrary Units
Standard Deviation 1.8
|
2.6 Arbitrary Units
Standard Deviation 1.4
|
1.6 Arbitrary Units
Standard Deviation 0.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 weeksPopulation: RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed.
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.
Outcome measures
| Measure |
Arm 1- 125mg PrimaVie
n=13 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks.
|
Arm 2- 250mg PrimaVie
n=11 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks.
|
Arm 3- Placebo
n=10 Participants
15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.
|
|---|---|---|---|
|
Gene Chip Analysis - PRKG1 - Protein Kinase, cGMP-Dependent, Type I
|
2.5 Arbitrary Units
Standard Deviation 1.2
|
2.3 Arbitrary Units
Standard Deviation 3.1
|
1.5 Arbitrary Units
Standard Deviation 1.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 weeksPopulation: RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed.
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.
Outcome measures
| Measure |
Arm 1- 125mg PrimaVie
n=13 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks.
|
Arm 2- 250mg PrimaVie
n=11 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks.
|
Arm 3- Placebo
n=10 Participants
15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.
|
|---|---|---|---|
|
Gene Chip Analysis - SERPINE1 - Serpin Family E Member 1 (Plasminogen Activator Inhibitor-1, PAI-1)
|
2.5 Arbitrary Units
Standard Deviation 1.3
|
2.2 Arbitrary Units
Standard Deviation 1.2
|
1.5 Arbitrary Units
Standard Deviation 0.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 weeksPopulation: RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed.
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.
Outcome measures
| Measure |
Arm 1- 125mg PrimaVie
n=13 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks.
|
Arm 2- 250mg PrimaVie
n=11 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks.
|
Arm 3- Placebo
n=10 Participants
15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.
|
|---|---|---|---|
|
Gene Chip Analysis - SPARC - Secreted Protein Acidic and Cysteine Rich
|
5.0 Arbitrary Units
Standard Deviation 7.3
|
3.8 Arbitrary Units
Standard Deviation 4.3
|
1.9 Arbitrary Units
Standard Deviation 1.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 weeksPopulation: RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed.
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.
Outcome measures
| Measure |
Arm 1- 125mg PrimaVie
n=13 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks.
|
Arm 2- 250mg PrimaVie
n=11 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks.
|
Arm 3- Placebo
n=10 Participants
15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.
|
|---|---|---|---|
|
Gene Chip Analysis - THBS2 - Thrombospondin 2
|
3.2 Arbitrary Units
Standard Deviation 4.7
|
2.1 Arbitrary Units
Standard Deviation 2.3
|
1.5 Arbitrary Units
Standard Deviation 0.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 weeksPopulation: RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed.
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.
Outcome measures
| Measure |
Arm 1- 125mg PrimaVie
n=13 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks.
|
Arm 2- 250mg PrimaVie
n=11 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks.
|
Arm 3- Placebo
n=10 Participants
15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.
|
|---|---|---|---|
|
Gene Chip Analysis - TIMP1 - Tissue Inhibitor of Metalloproteinases 1
|
1.5 Arbitrary Units
Standard Deviation 0.6
|
1.2 Arbitrary Units
Standard Deviation 0.3
|
0.9 Arbitrary Units
Standard Deviation 0.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 weeksPopulation: RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed.
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.
Outcome measures
| Measure |
Arm 1- 125mg PrimaVie
n=13 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks.
|
Arm 2- 250mg PrimaVie
n=11 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks.
|
Arm 3- Placebo
n=10 Participants
15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.
|
|---|---|---|---|
|
Gene Chip Analysis - TIMP2 - Tissue Inhibitor of Metalloproteinases 2
|
2.0 Arbitrary Units
Standard Deviation 1.3
|
1.4 Arbitrary Units
Standard Deviation 0.5
|
1.2 Arbitrary Units
Standard Deviation 0.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 weeksPopulation: RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed.
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.
Outcome measures
| Measure |
Arm 1- 125mg PrimaVie
n=13 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks.
|
Arm 2- 250mg PrimaVie
n=11 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks.
|
Arm 3- Placebo
n=10 Participants
15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.
|
|---|---|---|---|
|
Gene Chip Analysis - TNN - Tenascin N
|
5.6 Arbitrary Units
Standard Deviation 7.8
|
2.7 Arbitrary Units
Standard Deviation 2.6
|
1.8 Arbitrary Units
Standard Deviation 2.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 weeksPopulation: RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed.
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.
Outcome measures
| Measure |
Arm 1- 125mg PrimaVie
n=13 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks.
|
Arm 2- 250mg PrimaVie
n=11 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks.
|
Arm 3- Placebo
n=10 Participants
15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.
|
|---|---|---|---|
|
Gene Chip Analysis - RECK - Reversion-Inducing Cysteine-Rich Protein With Kazal Motifs
|
2.1 Arbitrary Units
Standard Deviation 1.1
|
1.4 Arbitrary Units
Standard Deviation 0.8
|
1.2 Arbitrary Units
Standard Deviation 0.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 weeksPopulation: RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed.
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.
Outcome measures
| Measure |
Arm 1- 125mg PrimaVie
n=13 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks.
|
Arm 2- 250mg PrimaVie
n=11 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks.
|
Arm 3- Placebo
n=10 Participants
15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.
|
|---|---|---|---|
|
Gene Chip Analysis - COL1A1 - Collagen Type I Alpha 1 Chain
|
7.7 Arbitrary Units
Standard Deviation 9.4
|
6.1 Arbitrary Units
Standard Deviation 4.1
|
3.5 Arbitrary Units
Standard Deviation 5.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 weeksPopulation: RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed.
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.
Outcome measures
| Measure |
Arm 1- 125mg PrimaVie
n=13 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks.
|
Arm 2- 250mg PrimaVie
n=11 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks.
|
Arm 3- Placebo
n=10 Participants
15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.
|
|---|---|---|---|
|
Gene Chip Analysis - COL5A2 - Collagen Type V Alpha 2 Chain
|
4.3 Arbitrary Units
Standard Deviation 7.5
|
3.7 Arbitrary Units
Standard Deviation 4.0
|
2.4 Arbitrary Units
Standard Deviation 3.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 weeksPopulation: RNA was extracted from skin biopsies from study participants, and gene chip analysis (Affymetrix) performed.
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.
Outcome measures
| Measure |
Arm 1- 125mg PrimaVie
n=13 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks.
|
Arm 2- 250mg PrimaVie
n=11 Participants
15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks.
|
Arm 3- Placebo
n=10 Participants
15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.
|
|---|---|---|---|
|
Gene Chip Analysis - COL14A1 - Collagen Type XIV Alpha 1 Chain
|
4.6 Arbitrary Units
Standard Deviation 8.1
|
2.8 Arbitrary Units
Standard Deviation 1.7
|
2.3 Arbitrary Units
Standard Deviation 3.2
|
Adverse Events
Arm 1
Arm 2
Arm 3
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place