Chemical, Manufacturing, and Standardization Controls of Grape Polyphenol Dietary Supplements in Support of a Clinical Study: Mass Uniformity, Polyphenol Dosage, and Profiles
Bioactive dietary polyphenols in grape (Vitis vinifera) have been used in Dietary Supplements (DSs) with the aim to prevent numerous diseases, including cardiovascular and neurodegenerative diseases, and to reduce depression and anxiety. Given prior recognition that DSs can be quality challenged fro...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2021-12-01
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| Series: | Frontiers in Nutrition |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fnut.2021.780226/full |
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| author | Weiting Lyu Weiting Lyu David Rodriguez Mario G. Ferruzzi Giulio M. Pasinetti Giulio M. Pasinetti James W. Murrough James W. Murrough James E. Simon James E. Simon Qingli Wu Qingli Wu |
| author_facet | Weiting Lyu Weiting Lyu David Rodriguez Mario G. Ferruzzi Giulio M. Pasinetti Giulio M. Pasinetti James W. Murrough James W. Murrough James E. Simon James E. Simon Qingli Wu Qingli Wu |
| author_sort | Weiting Lyu |
| collection | DOAJ |
| description | Bioactive dietary polyphenols in grape (Vitis vinifera) have been used in Dietary Supplements (DSs) with the aim to prevent numerous diseases, including cardiovascular and neurodegenerative diseases, and to reduce depression and anxiety. Given prior recognition that DSs can be quality challenged from the purity, authentication, adulteration, and actual concentration of targeted bioactives, to ensure consumer health protection as well as the quality and safety of grape polyphenol-based DSs, the present investigation was aimed at establishing a comprehensive quality control (QC) approach for grape polyphenol-based DSs in support of a human clinical study. In this study, the manufactured grape seed polyphenol extract (GSPE) and trans-resveratrol (RSV) capsules and Concord Grape Juice (CGJ) along with the corresponding original drug materials were analyzed using the developed different liquid chromatography/UV-visible spectroscopy/mass spectrometry (LC/UV-Vis/MS) methods. The weight variation of GSPE and RSV capsules was also evaluated according to the US Pharmacopeia (USP) tests. The results indicate that the total identified polyphenol content in each grape seed extract (GSE) capsule/CGJ is very similar and all GSE/RSV capsules pass the content/weight uniformity test. Given the complexity of these and many botanical products from the issues of purity, quality, adulteration, consistency, and their coupling to the complex chemistry in each grape-derived botanical, quality assurance and the steps needed to ensure grape-derived DSs being well homogeneous and stable and containing the known and expected bioactives at specific concentration ranges are fundamental to any research study and in particular to a clinical trial. Each of these issues is essential to provide a solid foundation upon which clinical trials with botanicals can be conducted with the goal of realizing measurable mental health outcomes such as reducing depression and anxiety as well as understanding of their underlying biological mechanisms. |
| first_indexed | 2024-12-13T21:20:37Z |
| format | Article |
| id | doaj.art-371654d2754c45faaae1ab591bae38a8 |
| institution | Directory Open Access Journal |
| issn | 2296-861X |
| language | English |
| last_indexed | 2024-12-13T21:20:37Z |
| publishDate | 2021-12-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Nutrition |
| spelling | doaj.art-371654d2754c45faaae1ab591bae38a82022-12-21T23:31:07ZengFrontiers Media S.A.Frontiers in Nutrition2296-861X2021-12-01810.3389/fnut.2021.780226780226Chemical, Manufacturing, and Standardization Controls of Grape Polyphenol Dietary Supplements in Support of a Clinical Study: Mass Uniformity, Polyphenol Dosage, and ProfilesWeiting Lyu0Weiting Lyu1David Rodriguez2Mario G. Ferruzzi3Giulio M. Pasinetti4Giulio M. Pasinetti5James W. Murrough6James W. Murrough7James E. Simon8James E. Simon9Qingli Wu10Qingli Wu11New Use Agriculture and Natural Plant Products Program, Department of Plant Biology and Center for Agricultural Food Ecosystems, Institute of Food, Nutrition & Health, Rutgers University, New Brunswick, NJ, United StatesDepartment of Medicinal Chemistry, Ernest Mario School of Pharmacy, Rutgers University, Piscataway, NJ, United StatesIndependent Researcher, Carlstadt, NJ, United StatesDepartment of Food, Bioprocessing and Nutrition Sciences, Plants for Human Health Institute, North Carolina State University, Kannapolis, NC, United StatesDepartment of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, United StatesGeriatric Research, Education and Clinical Center, James J. Peters Veterans Affairs Medical Center, Bronx, NY, United StatesDepartment of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, United StatesDepression and Anxiety Center for Discovery and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, United StatesNew Use Agriculture and Natural Plant Products Program, Department of Plant Biology and Center for Agricultural Food Ecosystems, Institute of Food, Nutrition & Health, Rutgers University, New Brunswick, NJ, United StatesDepartment of Medicinal Chemistry, Ernest Mario School of Pharmacy, Rutgers University, Piscataway, NJ, United StatesNew Use Agriculture and Natural Plant Products Program, Department of Plant Biology and Center for Agricultural Food Ecosystems, Institute of Food, Nutrition & Health, Rutgers University, New Brunswick, NJ, United StatesDepartment of Medicinal Chemistry, Ernest Mario School of Pharmacy, Rutgers University, Piscataway, NJ, United StatesBioactive dietary polyphenols in grape (Vitis vinifera) have been used in Dietary Supplements (DSs) with the aim to prevent numerous diseases, including cardiovascular and neurodegenerative diseases, and to reduce depression and anxiety. Given prior recognition that DSs can be quality challenged from the purity, authentication, adulteration, and actual concentration of targeted bioactives, to ensure consumer health protection as well as the quality and safety of grape polyphenol-based DSs, the present investigation was aimed at establishing a comprehensive quality control (QC) approach for grape polyphenol-based DSs in support of a human clinical study. In this study, the manufactured grape seed polyphenol extract (GSPE) and trans-resveratrol (RSV) capsules and Concord Grape Juice (CGJ) along with the corresponding original drug materials were analyzed using the developed different liquid chromatography/UV-visible spectroscopy/mass spectrometry (LC/UV-Vis/MS) methods. The weight variation of GSPE and RSV capsules was also evaluated according to the US Pharmacopeia (USP) tests. The results indicate that the total identified polyphenol content in each grape seed extract (GSE) capsule/CGJ is very similar and all GSE/RSV capsules pass the content/weight uniformity test. Given the complexity of these and many botanical products from the issues of purity, quality, adulteration, consistency, and their coupling to the complex chemistry in each grape-derived botanical, quality assurance and the steps needed to ensure grape-derived DSs being well homogeneous and stable and containing the known and expected bioactives at specific concentration ranges are fundamental to any research study and in particular to a clinical trial. Each of these issues is essential to provide a solid foundation upon which clinical trials with botanicals can be conducted with the goal of realizing measurable mental health outcomes such as reducing depression and anxiety as well as understanding of their underlying biological mechanisms.https://www.frontiersin.org/articles/10.3389/fnut.2021.780226/fullbotanicalsquality controlgrape seed extract (GSE)resveratrolgrape juiceLC/UV-Vis/MS |
| spellingShingle | Weiting Lyu Weiting Lyu David Rodriguez Mario G. Ferruzzi Giulio M. Pasinetti Giulio M. Pasinetti James W. Murrough James W. Murrough James E. Simon James E. Simon Qingli Wu Qingli Wu Chemical, Manufacturing, and Standardization Controls of Grape Polyphenol Dietary Supplements in Support of a Clinical Study: Mass Uniformity, Polyphenol Dosage, and Profiles Frontiers in Nutrition botanicals quality control grape seed extract (GSE) resveratrol grape juice LC/UV-Vis/MS |
| title | Chemical, Manufacturing, and Standardization Controls of Grape Polyphenol Dietary Supplements in Support of a Clinical Study: Mass Uniformity, Polyphenol Dosage, and Profiles |
| title_full | Chemical, Manufacturing, and Standardization Controls of Grape Polyphenol Dietary Supplements in Support of a Clinical Study: Mass Uniformity, Polyphenol Dosage, and Profiles |
| title_fullStr | Chemical, Manufacturing, and Standardization Controls of Grape Polyphenol Dietary Supplements in Support of a Clinical Study: Mass Uniformity, Polyphenol Dosage, and Profiles |
| title_full_unstemmed | Chemical, Manufacturing, and Standardization Controls of Grape Polyphenol Dietary Supplements in Support of a Clinical Study: Mass Uniformity, Polyphenol Dosage, and Profiles |
| title_short | Chemical, Manufacturing, and Standardization Controls of Grape Polyphenol Dietary Supplements in Support of a Clinical Study: Mass Uniformity, Polyphenol Dosage, and Profiles |
| title_sort | chemical manufacturing and standardization controls of grape polyphenol dietary supplements in support of a clinical study mass uniformity polyphenol dosage and profiles |
| topic | botanicals quality control grape seed extract (GSE) resveratrol grape juice LC/UV-Vis/MS |
| url | https://www.frontiersin.org/articles/10.3389/fnut.2021.780226/full |
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