Исследование Natreon Healthy Skin – добавка PrimaVie
Способность пероральной добавки улучшать микроперфузию кожи, увлажнение, эластичность и барьерную функцию
Обзор исследования
Статус
Условия
Подробное описание
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 1
Контакты и местонахождение
Места учебы
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Ohio
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Columbus, Ohio, Соединенные Штаты, 43210
- Davis Heart and Lung Research Institute
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Columbus, Ohio, Соединенные Штаты, 43221
- Martha Morehouse Medical Plaza 2050 Kenny Road
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Columbus, Ohio, Соединенные Штаты, 43205
- OSU Hospital East
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Описание
Критерии включения:
- Субъекты, желающие прекратить прием любых диетических или пищевых добавок, кроме поливитаминов общего назначения, начиная с двух недель до начала исследования, а также во время исследования.
- Субъекты должны быть готовы сохранить свою текущую диету без серьезных изменений на протяжении всего исследования.
- Субъекты должны быть готовы принимать пищевые добавки, как того требует протокол исследования, два раза в день.
- Субъекты женского пола должны быть в возрасте от 30 до 65 лет.
- Субъекты должны предоставить письменное информированное согласие и готовы соблюдать все процедуры исследования.
Критерий исключения:
- Любое дерматологическое заболевание, которое может помешать точной оценке состояния кожи субъекта.
- Субъекты, которые беременны, кормят грудью или планируют беременность.
- Клинически значимые нестабильные медицинские расстройства.
- История, диабет, болезни сердца или почек
- История психологического заболевания или состояния, которое может помешать их способности понимать и следовать требованиям исследования.
- Любое кожное заболевание в области верхней внутренней части руки, где будут получены биопсии.
В настоящее время принимает следующие препараты:
- Стероиды
- Бета-блокаторы
- Иммунодепрессанты
- гидрохлоротиазид,
- Статины
- Аспирин
- Ингибиторы АПФ
- Миорелаксанты
- Стимуляторы
- Заключенные
- Мужчины
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Активный компаратор: 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 мг два раза в день в течение 14 недель в группе 1
Другие имена:
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Активный компаратор: 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 мг два раза в день в течение 14 недель в группе 2
Другие имена:
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Плацебо Компаратор: Arm 3
15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.
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Добавка плацебо для приема два раза в день в течение 14 недель в группе 3
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Improvement in Non-invasive Skin Assessment of Skin Microperfusion
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Анализ генных чипов
Временное ограничение: 14 недель
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определить повышающую или понижающую регуляцию ключевых маркеров юношеской кожи (экспрессии генов), вырабатываемых добавкой по сравнению с плацебо, что было выявлено с помощью анализа генных чипов после 14 недель перорального приема добавок.
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14 недель
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Gene Chip Analysis- ITGA5 - Integrin Subunit Alpha 5
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Gayle M Gordillo, M.D., Indiana University
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оцененный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- DCS-71-14
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .