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Badanie zdrowej skóry Natreon - Suplement PrimaVie

1 czerwca 2026 zaktualizowane przez: Gayle Gordillo, Ohio State University

Zdolność doustnego suplementu do poprawy mikroperfuzji, nawilżenia, elastyczności i funkcji bariery skórnej

Badanie to wykaże zdolność doustnego suplementu PrimaVie® do poprawy mikroperfuzji, nawilżenia, elastyczności i funkcji bariery skórnej. 45 kobiet zostanie włączonych do 1 z 3 ramion, w których otrzymają 125 mg PrimaVie, 250 mg PrimaVie lub placebo (grupa kontrolna) dwa razy dziennie przez 14 tygodni.

Przegląd badań

Szczegółowy opis

Uczestnicy będą oceniani na podstawie typu skóry Fitzpatricka, jaki mają, wrócą łącznie na 6 wizyt studyjnych w ciągu 14 tygodni, podczas których w trakcie badania będą miały miejsce następujące działania badawcze: historia medyczna/dietetyczna, przyjmowane leki być rejestrowane, randomizacja suplementu w oparciu o jedną z trzech grup będzie miała miejsce podczas pierwszej wizyty badawczej, a dystrybucja badanego produktu będzie miała miejsce podczas wszystkich wizyt studyjnych, ocena tolerancji suplementu, ocena wyglądu badacza i osoby badanej, fotografia twarzy (lewej, prawej i przód), nieinwazyjne oceny obejmujące przeznaskórkową utratę wody, nawodnienie, elastyczność, laserową perfuzję plamkową, biopsję skóry lewej wewnętrznej części ramienia (tylko podczas wizyt w ramach badania 2 i 6), przegląd zdarzeń niepożądanych i uzupełnienie kontrola licznika/zgodności.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

45

Faza

  • Faza 1

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

30 lat do 65 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Opis

Kryteria przyjęcia:

  • Osoby chętne do zaprzestania przyjmowania jakichkolwiek suplementów diety lub składników odżywczych innych niż ogólna multiwitamina, począwszy od dwóch tygodni przed rozpoczęciem badania, a także w trakcie badania.
  • Pacjenci muszą być chętni do utrzymania obecnej diety bez większych zmian w trakcie badania.
  • Pacjenci muszą być chętni do przyjmowania suplementów diety zgodnie z protokołem badania dwa razy dziennie.
  • Kobiety muszą być w wieku od 30 do 65 lat
  • Uczestnicy muszą wyrazić pisemną świadomą zgodę i są gotowi do przestrzegania wszystkich procedur badawczych.

Kryteria wyłączenia:

  • Wszelkie zaburzenia dermatologiczne, które mogą zakłócać dokładną ocenę skóry pacjenta.
  • Osoby w ciąży, karmiące piersią lub planujące ciążę.
  • Klinicznie istotne niestabilne zaburzenia medyczne.
  • Historia, cukrzyca, choroby serca lub nerek
  • Historia choroby psychicznej lub stanu, który zakłócałby ich zdolność zrozumienia i przestrzegania wymagań badania.
  • Jakakolwiek choroba skóry w obszarze wewnętrznej części ramienia, w której zostaną wykonane biopsje.
  • Obecnie przyjmuje następujące leki:

    • Steroidy
    • Beta-blokery
    • immunosupresyjne
    • hydrochlorotiazyd,
    • statyny
    • Aspiryna
    • Inhibitory ACE
    • Leki zwiotczające mięśnie
    • stymulanty
  • Więźniowie
  • Mężczyźni

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Inny
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Arm 1
15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks.
125 mg do przyjmowania BID przez 14 tygodni w Ramie 1
Inne nazwy:
  • PrimaVie
Aktywny komparator: Arm 2
15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks.
250 mg do przyjmowania BID przez 14 tygodni w Ramie 2
Inne nazwy:
  • PrimaVie
Komparator placebo: Arm 3
15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.
Suplement placebo do przyjmowania BID przez 14 tygodni w Ramie 3
Inne nazwy:
  • dodatek kontrolny

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Improvement in Non-invasive Skin Assessment of Skin Microperfusion
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Analiza chipów genowych
Ramy czasowe: 14 tygodni
zidentyfikować regulację w górę lub w dół kluczowych młodzieńczych markerów skóry (ekspresja genów) wytwarzanych przez suplement w porównaniu z placebo, co zidentyfikowano za pomocą analizy chipów genetycznych po 14 tygodniach doustnej suplementacji.
14 tygodni

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Gene Chip Analysis- ITGA5 - Integrin Subunit Alpha 5
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Współpracownicy

Śledczy

  • Główny śledczy: Gayle M Gordillo, M.D., Indiana University

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

20 lutego 2016

Zakończenie podstawowe (Rzeczywisty)

1 grudnia 2018

Ukończenie studiów (Rzeczywisty)

20 grudnia 2019

Daty rejestracji na studia

Pierwszy przesłany

21 marca 2016

Pierwszy przesłany, który spełnia kryteria kontroli jakości

3 maja 2016

Pierwszy wysłany (Szacowany)

4 maja 2016

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

25 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

1 czerwca 2026

Ostatnia weryfikacja

1 marca 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • DCS-71-14

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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