Natreon-Studie zu gesunder Haut – PrimaVie-Ergänzung
Die Fähigkeit eines oralen Nahrungsergänzungsmittels zur Verbesserung der Mikroperfusion, Hydratation, Elastizität und Barrierefunktion der Haut
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
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Ohio
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Columbus, Ohio, Vereinigte Staaten, 43210
- Davis Heart and Lung Research Institute
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Columbus, Ohio, Vereinigte Staaten, 43221
- Martha Morehouse Medical Plaza 2050 Kenny Road
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Columbus, Ohio, Vereinigte Staaten, 43205
- OSU Hospital East
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Beschreibung
Einschlusskriterien:
- Probanden, die bereit sind, alle anderen Nahrungsergänzungsmittel oder Nahrungsergänzungsmittel als ein allgemeines Multivitaminpräparat abzusetzen, beginnend zwei Wochen vor Studienbeginn und auch während der Studie.
- Die Probanden müssen bereit sein, ihre derzeitige Ernährung ohne größere Änderungen während der gesamten Studie beizubehalten.
- Die Probanden müssen bereit sein, die im Studienprotokoll vorgeschriebenen Nahrungsergänzungsmittel zweimal täglich einzunehmen.
- Weibliche Probanden müssen zwischen 30 und 65 Jahre alt sein
- Die Probanden müssen eine schriftliche Einverständniserklärung abgeben und sind bereit, alle Studienverfahren einzuhalten.
Ausschlusskriterien:
- Jede dermatologische Erkrankung, die die genaue Beurteilung der Haut des Probanden beeinträchtigen könnte.
- Probanden, die schwanger sind, stillen oder eine Schwangerschaft planen.
- Klinisch signifikante instabile medizinische Störungen.
- Geschichte von, Diabetes, Herz- oder Nierenerkrankungen
- Geschichte einer psychischen Krankheit oder eines Zustands, der ihre Fähigkeit beeinträchtigen würde, die Anforderungen der Studie zu verstehen und zu befolgen.
- Jede Hauterkrankung im Bereich des oberen Innenarms, wo die Biopsien entnommen werden.
Derzeit nehme ich folgende Medikamente:
- Steroide
- Betablocker
- Immunsuppressiva
- Hydrochlorothiazid,
- Statine
- Aspirin
- ACE-Hemmer
- Muskelrelaxantien
- Stimulanzien
- Gefangene
- Männchen
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Aktiver Komparator: Arm 1
15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks.
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125 mg zur Einnahme BID für 14 Wochen in Arm 1
Andere Namen:
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Aktiver Komparator: Arm 2
15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks.
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250 mg zur Einnahme BID für 14 Wochen in Arm 2
Andere Namen:
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Placebo-Komparator: Arm 3
15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.
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Placebo-Ergänzung zur Einnahme von BID für 14 Wochen in Arm 3
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Improvement in Non-invasive Skin Assessment of Skin Microperfusion
Zeitfenster: 14 weeks after oral supplementation
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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.
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14 weeks after oral supplementation
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Improvement in Non-invasive Skin Assessment of Hydration
Zeitfenster: 14 weeks after oral supplementation
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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.
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14 weeks after oral supplementation
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Improvement in Non-invasive Skin Assessment of Elasticity
Zeitfenster: 14 weeks after oral supplementation
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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.
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14 weeks after oral supplementation
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Improvement in Non-invasive Skin Assessment of Barrier Function
Zeitfenster: 14 weeks after oral supplementation
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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.
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14 weeks after oral supplementation
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Gen-Chip-Analyse
Zeitfenster: 14 Wochen
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Identifizieren Sie die Herauf- oder Herunterregulierung wichtiger jugendlicher Hautmarker (Genexpression), die durch die Ergänzung gegenüber dem Placebo erzeugt werden, wie durch Gen-Chip-Analyse nach 14 Wochen oraler Ergänzung identifiziert.
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14 Wochen
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Gene Chip Analysis- ITGA5 - Integrin Subunit Alpha 5
Zeitfenster: 14 weeks
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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
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Gene Chip Analysis: JAM3 - Junctional Adhesion Molecule 3
Zeitfenster: 14 weeks
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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
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Gene Chip Analysis - LGALS1 - Galectin 1
Zeitfenster: 14 weeks
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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
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Gene Chip Analysis - LOX- Lysyl Oxidase
Zeitfenster: 14 weeks
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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
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Gene Chip Analysis - MMP2 - Matrix Metallopeptidase 2
Zeitfenster: 14 weeks
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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
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Gene Chip Analysis - PDGFRB - Platelet-Derived Growth Factor Receptor Beta
Zeitfenster: 14 weeks
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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
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Gene Chip Analysis - PRKG1 - Protein Kinase, cGMP-Dependent, Type I
Zeitfenster: 14 weeks
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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
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Gene Chip Analysis - SERPINE1 - Serpin Family E Member 1 (Plasminogen Activator Inhibitor-1, PAI-1)
Zeitfenster: 14 weeks
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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
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Gene Chip Analysis - SPARC - Secreted Protein Acidic and Cysteine Rich
Zeitfenster: 14 weeks
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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
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Gene Chip Analysis - THBS2 - Thrombospondin 2
Zeitfenster: 14 weeks
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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
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Gene Chip Analysis - TIMP1 - Tissue Inhibitor of Metalloproteinases 1
Zeitfenster: 14 weeks
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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
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Gene Chip Analysis - TIMP2 - Tissue Inhibitor of Metalloproteinases 2
Zeitfenster: 14 weeks
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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
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Gene Chip Analysis - TNN - Tenascin N
Zeitfenster: 14 weeks
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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
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Gene Chip Analysis - RECK - Reversion-Inducing Cysteine-Rich Protein With Kazal Motifs
Zeitfenster: 14 weeks
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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
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Gene Chip Analysis - COL1A1 - Collagen Type I Alpha 1 Chain
Zeitfenster: 14 weeks
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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
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Gene Chip Analysis - COL5A2 - Collagen Type V Alpha 2 Chain
Zeitfenster: 14 weeks
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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
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Gene Chip Analysis - COL14A1 - Collagen Type XIV Alpha 1 Chain
Zeitfenster: 14 weeks
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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
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Gayle M Gordillo, M.D., Indiana University
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Geschätzt)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- DCS-71-14
Plan für individuelle Teilnehmerdaten (IPD)
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