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Studio sulla pelle sana Natreon - Supplemento PrimaVie

1 giugno 2026 aggiornato da: Gayle Gordillo, Ohio State University

La capacità di un integratore orale di migliorare la microperfusione, l'idratazione, l'elasticità e la funzione barriera della pelle

Questo studio dimostrerà la capacità dell'integratore orale PrimaVie® di migliorare la microperfusione, l'idratazione, l'elasticità e la funzione barriera della pelle. 45 donne saranno arruolate in 1 braccio su 3 dove riceveranno 125 mg di PrimaVie, 250 mg di PrimaVie o placebo (controllo) da assumere due volte al giorno per 14 settimane.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

I soggetti saranno valutati in base al tipo di tipo di pelle Fitzpatrick che hanno, torneranno per un totale di 6 visite di studio nell'arco di 14 settimane in cui si svolgeranno le seguenti attività di ricerca nel corso dello studio: anamnesi medica/dietetica, farmaci essere registrato, la randomizzazione del supplemento basata su uno dei tre bracci avverrà alla visita dello studio 1 e la distribuzione del prodotto dello studio avverrà a tutte le visite dello studio, la valutazione della tollerabilità del supplemento, la valutazione dell'aspetto dello sperimentatore e del soggetto, la fotografia del volto (a sinistra, a destra e anteriore) saranno prese, valutazioni non invasive tra cui perdita di acqua transepidermica, idratazione, elasticità, perfusione di macchie laser, una biopsia cutanea della parte interna del braccio sinistro (solo alle visite di studio 2 e 6), revisione degli eventi avversi e supplemento conteggio/revisione della conformità.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

45

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 30 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Descrizione

Criterio di inclusione:

  • - Soggetti disposti a interrompere qualsiasi integratore alimentare o nutrizionale, diverso da un multivitaminico generale, a partire da due settimane prima dell'inizio dello studio e anche durante lo studio.
  • I soggetti devono essere disposti a mantenere la loro dieta attuale senza grandi cambiamenti durante lo studio.
  • I soggetti devono essere disposti a prendere gli integratori alimentari come richiesto dal protocollo di studio due volte al giorno.
  • I soggetti di sesso femminile devono avere un'età compresa tra i 30 ei 65 anni
  • I soggetti devono fornire il consenso informato scritto e sono disposti a rispettare tutte le procedure dello studio.

Criteri di esclusione:

  • Qualsiasi disturbo dermatologico che possa interferire con l'accurata valutazione della pelle del soggetto.
  • Soggetti in gravidanza, allattamento o che stanno pianificando una gravidanza.
  • Disturbi medici instabili clinicamente significativi.
  • Storia di, diabete, malattie cardiache o renali
  • Storia di una malattia o condizione psicologica che interferirebbe con la loro capacità di comprendere e seguire i requisiti dello studio.
  • Qualsiasi malattia della pelle nell'area della parte superiore del braccio interno in cui verranno ottenute le biopsie.

  • Attualmente sto assumendo i seguenti farmaci:

    • Steroidi
    • Beta-bloccanti
    • Immunosoppressori
    • Idoclorotiazide,
    • Statine
    • Aspirina
    • ACE-inibitori
    • Rilassanti muscolari
    • Stimolanti
  • Prigionieri
  • Maschi

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Arm 1
15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks.
Integratore alimentare: Integratore a base di erbe PrimaVie 125
125 mg da assumere BID per 14 settimane nel Braccio 1
Altri nomi:
  • PrimaVie
Comparatore attivo: Arm 2
15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks.
Integratore alimentare: Integratore a base di erbe PrimaVie 250
250 mg da assumere BID per 14 settimane nel Braccio 2
Altri nomi:
  • PrimaVie
Comparatore placebo: Arm 3
15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.
Droga: Placebo
Supplemento placebo per assumere BID per 14 settimane nel Braccio 3
Altri nomi:
  • supplemento di controllo

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Improvement in Non-invasive Skin Assessment of Skin Microperfusion
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Analisi del chip genico
Lasso di tempo: 14 settimane
identificare la regolazione verso l'alto o verso il basso dei marcatori chiave della pelle giovanile (espressione genica) prodotti dall'integratore rispetto al placebo come identificato dall'analisi del chip genetico dopo 14 settimane di integrazione orale.
14 settimane

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Gene Chip Analysis- ITGA5 - Integrin Subunit Alpha 5
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Ohio State University

Collaboratori

Natreon, Inc.

Investigatori

  • Investigatore principale: Gayle M Gordillo, M.D., Indiana University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 febbraio 2016

Completamento primario (Effettivo)

1 dicembre 2018

Completamento dello studio (Effettivo)

20 dicembre 2019

Date di iscrizione allo studio

Primo inviato

21 marzo 2016

Primo inviato che soddisfa i criteri di controllo qualità

3 maggio 2016

Primo Inserito (Stimato)

4 maggio 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 giugno 2026

Ultimo verificato

1 marzo 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • DCS-71-14

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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