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Natreon Healthy Skin Study - PrimaVie-supplement

1 juni 2026 bijgewerkt door: Gayle Gordillo, Ohio State University

Het vermogen van een oraal supplement om de microperfusie, hydratatie, elasticiteit en barrièrefunctie van de huid te verbeteren

Deze studie zal het vermogen aantonen van het orale supplement, PrimaVie®, om de microperfusie, hydratatie, elasticiteit en barrièrefunctie van de huid te verbeteren. 45 vrouwen zullen worden ingeschreven in 1 van de 3 armen waar ze ofwel 125 mg PrimaVie, 250 mg PrimaVie of placebo (controle) zullen krijgen om gedurende 14 weken tweemaal daags in te nemen.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Proefpersonen zullen worden beoordeeld op basis van het type Fitzpatrick-huidtype dat ze hebben, zullen worden teruggestuurd voor in totaal 6 studiebezoeken gedurende 14 weken, waarbij de volgende onderzoeksactiviteiten zullen plaatsvinden in de loop van het onderzoek: medische/dieetgeschiedenis, medicijnen zullen worden geregistreerd, aanvulling op randomisatie op basis van een van de drie armen vindt plaats tijdens studiebezoek 1, en distributie van het onderzoeksproduct vindt plaats tijdens alle studiebezoeken, aanvulling op verdraagbaarheidsbeoordeling, beoordeling van het uiterlijk van de onderzoeker en proefpersoon, fotografie van het gezicht (links, rechts en voorkant) worden afgenomen, niet-invasieve beoordelingen, waaronder transepidermaal waterverlies, hydratatie, elasticiteit, perfusie van laserspikkels, een huidbiopsie van de linker binnenbovenarm (alleen bij studiebezoeken 2 en 6), beoordeling van bijwerkingen en supplementen telling/nalevingsbeoordeling.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

45

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Ohio
      • Columbus, Ohio, Verenigde Staten, 43210
        • Davis Heart and Lung Research Institute
      • Columbus, Ohio, Verenigde Staten, 43221
        • Martha Morehouse Medical Plaza 2050 Kenny Road
      • Columbus, Ohio, Verenigde Staten, 43205
        • OSU Hospital East

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

30 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusiecriteria:

  • Proefpersonen die bereid zijn om te stoppen met alle voedings- of voedingssupplementen, behalve een algemene multivitamine, vanaf twee weken voor aanvang van het onderzoek en ook tijdens het onderzoek.
  • Proefpersonen moeten bereid zijn hun huidige dieet te behouden zonder grote veranderingen gedurende het onderzoek.
  • Proefpersonen moeten bereid zijn om de voedingssupplementen tweemaal daags in te nemen zoals vereist door het onderzoeksprotocol.
  • Vrouwelijke proefpersonen moeten tussen de 30 en 65 jaar oud zijn
  • Proefpersonen moeten schriftelijke geïnformeerde toestemming geven en zijn bereid om te voldoen aan alle onderzoeksprocedures.

Uitsluitingscriteria:

  • Elke dermatologische aandoening die de nauwkeurige evaluatie van de huid van de proefpersoon kan verstoren.
  • Onderwerpen die zwanger zijn, borstvoeding geven of een zwangerschap plannen.
  • Klinisch significante onstabiele medische aandoeningen.
  • Geschiedenis van diabetes, hart- of nierziekte
  • Geschiedenis van een psychische ziekte of aandoening die hun vermogen om de vereisten van het onderzoek te begrijpen en te volgen zou verstoren.
  • Elke huidaandoening in het gebied van de bovenarm waar de biopten worden genomen.

  • Gebruik momenteel de volgende medicijnen:

    • Steroïden
    • Bètablokkers
    • Immunosuppressiva
    • hydrochloorthiazide,
    • Statines
    • Aspirine
    • ACE-remmers
    • Spierverslappers
    • Stimulerende middelen
  • Gevangenen
  • Mannetjes

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Arm 1
15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks.
Voedingssupplement: PrimaVie Kruidensupplement 125
125 mg tweemaal daags in te nemen gedurende 14 weken in arm 1
Andere namen:
  • PrimaVie
Actieve vergelijker: Arm 2
15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks.
Voedingssupplement: PrimaVie Kruidensupplement 250
250 mg tweemaal daags in te nemen gedurende 14 weken in arm 2
Andere namen:
  • PrimaVie
Placebo-vergelijker: Arm 3
15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.
Geneesmiddel: Placebo
Placebo-supplement om BID gedurende 14 weken in arm 3 te nemen
Andere namen:
  • controle aanvulling

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Improvement in Non-invasive Skin Assessment of Skin Microperfusion
Tijdsspanne: 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.
14 weeks after oral supplementation
Improvement in Non-invasive Skin Assessment of Hydration
Tijdsspanne: 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.
14 weeks after oral supplementation
Improvement in Non-invasive Skin Assessment of Elasticity
Tijdsspanne: 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.
14 weeks after oral supplementation
Improvement in Non-invasive Skin Assessment of Barrier Function
Tijdsspanne: 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.
14 weeks after oral supplementation

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Gene Chip-analyse
Tijdsspanne: 14 weken
identificeer de opwaartse of neerwaartse regulatie van belangrijke jeugdige huidmarkers (genexpressie) geproduceerd door het supplement ten opzichte van de placebo zoals geïdentificeerd door genchipanalyse na 14 weken orale suppletie.
14 weken

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Gene Chip Analysis- ITGA5 - Integrin Subunit Alpha 5
Tijdsspanne: 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.
14 weeks
Gene Chip Analysis: JAM3 - Junctional Adhesion Molecule 3
Tijdsspanne: 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.
14 weeks
Gene Chip Analysis - LGALS1 - Galectin 1
Tijdsspanne: 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.
14 weeks
Gene Chip Analysis - LOX- Lysyl Oxidase
Tijdsspanne: 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.
14 weeks
Gene Chip Analysis - MMP2 - Matrix Metallopeptidase 2
Tijdsspanne: 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.
14 weeks
Gene Chip Analysis - PDGFRB - Platelet-Derived Growth Factor Receptor Beta
Tijdsspanne: 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.
14 weeks
Gene Chip Analysis - PRKG1 - Protein Kinase, cGMP-Dependent, Type I
Tijdsspanne: 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.
14 weeks
Gene Chip Analysis - SERPINE1 - Serpin Family E Member 1 (Plasminogen Activator Inhibitor-1, PAI-1)
Tijdsspanne: 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.
14 weeks
Gene Chip Analysis - SPARC - Secreted Protein Acidic and Cysteine Rich
Tijdsspanne: 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.
14 weeks
Gene Chip Analysis - THBS2 - Thrombospondin 2
Tijdsspanne: 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.
14 weeks
Gene Chip Analysis - TIMP1 - Tissue Inhibitor of Metalloproteinases 1
Tijdsspanne: 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.
14 weeks
Gene Chip Analysis - TIMP2 - Tissue Inhibitor of Metalloproteinases 2
Tijdsspanne: 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.
14 weeks
Gene Chip Analysis - TNN - Tenascin N
Tijdsspanne: 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 weeks
Gene Chip Analysis - RECK - Reversion-Inducing Cysteine-Rich Protein With Kazal Motifs
Tijdsspanne: 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.
14 weeks
Gene Chip Analysis - COL1A1 - Collagen Type I Alpha 1 Chain
Tijdsspanne: 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.
14 weeks
Gene Chip Analysis - COL5A2 - Collagen Type V Alpha 2 Chain
Tijdsspanne: 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.
14 weeks
Gene Chip Analysis - COL14A1 - Collagen Type XIV Alpha 1 Chain
Tijdsspanne: 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.
14 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ohio State University

Medewerkers

Natreon, Inc.

Onderzoekers

  • Hoofdonderzoeker: Gayle M Gordillo, M.D., Indiana University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

20 februari 2016

Primaire voltooiing (Werkelijk)

1 december 2018

Studie voltooiing (Werkelijk)

20 december 2019

Studieregistratiedata

Eerst ingediend

21 maart 2016

Eerst ingediend dat voldeed aan de QC-criteria

3 mei 2016

Eerst geplaatst (Geschat)

4 mei 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

1 juni 2026

Laatst geverifieerd

1 maart 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • DCS-71-14

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

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