Abstract
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.
Highlights
Consumer interest in the use of botanical dietary supplements (DSs) continues to increase
The weight variation of grape seed extract (GSE) and RSV capsules was evaluated according to the US Pharmacopeia (USP) tests
GSE capsules and Concord Grape Juice (CGJ) both possessed a high polyphenol content according to the total polyphenol content test
Summary
Consumer interest in the use of botanical dietary supplements (DSs) continues to increase. It is estimated that 77% of US adults consume DSs on a regular basis [2]. Grape and grapederived products contain a unique mixture of bioactive dietary polyphenols, which have long been reported to have antioxidant and positive health promoting effects and associated with the prevention of numerous diseases, including cardiovascular and neurodegenerative diseases as well as several forms of cancers [4–6]. Previous studies have investigated the disease preventative effect of some specific grape polyphenol forms, including resveratrol (RSV), proanthocyanidins, and anthocyanins [7–9]. Grapes and their byproducts are the ideal candidates for DSs
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