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Completed

NCT Number: NCT02762032

Natreon Healthy Skin Study - PrimaVie Supplement

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.

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Key information

Conditions

Healthy

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Davis Heart and Lung Research Institute, Columbus, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects willing to discontinue any dietary or nutritional supplements, other than a general multivitamin, starting two weeks before onset of study and also during the study.
  • Subjects must be willing to maintain their present diet with no major changes throughout the study.
  • Subjects must be willing to take the dietary supplements as required by the study protocol twice daily.
  • Female subjects must be between the ages of 30 to 65 years of age
  • Subjects must provide written informed consent and are willing to comply with all study procedures.

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:
  • Steroids
  • Beta-blockers
  • Immunosuppressant's
  • Hydochlorothiazide,
  • Statins
  • Aspirin
  • ACE Inhibitors
  • Muscle relaxants
  • Stimulants
  • Prisoners
  • Males

Treatment and study plan

PrimaVie Herbal Supplement 125

Dietary Supplement

125 mg to take BID for 14 weeks in Arm 1

Other names: PrimaVie

PrimaVie Herbal Supplement 250

Dietary Supplement

250 mg to take BID for 14 weeks in Arm 2

Other names: PrimaVie

Placebo

Drug

Placebo supplement to take BID for 14 weeks in Arm 3

Other names: control supplement

Primary outcomes

  1. Improvement in Non-invasive Skin Assessment of Skin Microperfusion

    Time frame: 14 weeks after oral supplementation

    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.

  2. Improvement in Non-invasive Skin Assessment of Hydration

    Time frame: 14 weeks after oral supplementation

    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.

  3. Improvement in Non-invasive Skin Assessment of Elasticity

    Time frame: 14 weeks after oral supplementation

    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.

  4. Improvement in Non-invasive Skin Assessment of Barrier Function

    Time frame: 14 weeks after oral supplementation

    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.

Other outcomes

  1. Gene Chip Analysis- ITGA5 - Integrin Subunit Alpha 5

    Time frame: 14 weeks

    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.

  2. Gene Chip Analysis: JAM3 - Junctional Adhesion Molecule 3

    Time frame: 14 weeks

    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.

  3. Gene Chip Analysis - LGALS1 - Galectin 1

    Time frame: 14 weeks

    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.

  4. Gene Chip Analysis - LOX- Lysyl Oxidase

    Time frame: 14 weeks

    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.

  5. Gene Chip Analysis - MMP2 - Matrix Metallopeptidase 2

    Time frame: 14 weeks

    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.

  6. Gene Chip Analysis - PDGFRB - Platelet-Derived Growth Factor Receptor Beta

    Time frame: 14 weeks

    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.

  7. Gene Chip Analysis - PRKG1 - Protein Kinase, cGMP-Dependent, Type I

    Time frame: 14 weeks

    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.

  8. Gene Chip Analysis - SERPINE1 - Serpin Family E Member 1 (Plasminogen Activator Inhibitor-1, PAI-1)

    Time frame: 14 weeks

    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.

  9. Gene Chip Analysis - SPARC - Secreted Protein Acidic and Cysteine Rich

    Time frame: 14 weeks

    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.

  10. Gene Chip Analysis - THBS2 - Thrombospondin 2

    Time frame: 14 weeks

    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.

  11. Gene Chip Analysis - TIMP1 - Tissue Inhibitor of Metalloproteinases 1

    Time frame: 14 weeks

    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.

  12. Gene Chip Analysis - TIMP2 - Tissue Inhibitor of Metalloproteinases 2

    Time frame: 14 weeks

    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.

  13. Gene Chip Analysis - TNN - Tenascin N

    Time frame: 14 weeks

    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. Gene Chip Analysis - RECK - Reversion-Inducing Cysteine-Rich Protein With Kazal Motifs

    Time frame: 14 weeks

    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.

  15. Gene Chip Analysis - COL1A1 - Collagen Type I Alpha 1 Chain

    Time frame: 14 weeks

    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.

  16. Gene Chip Analysis - COL5A2 - Collagen Type V Alpha 2 Chain

    Time frame: 14 weeks

    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.

  17. Gene Chip Analysis - COL14A1 - Collagen Type XIV Alpha 1 Chain

    Time frame: 14 weeks

    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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Natreon, Inc.

Registry information

Official study title

The Ability of an Oral Supplement to Improve Skin Microperfusion, Hydration, Elasticity, and Barrier Function

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
May 4, 2016
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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