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 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.

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Effect of polyphenol-rich grape seed extract on ambulatory blood pressure in subjects with pre- and stage I hypertension

British Journal Of Nutrition ◽

10.1017/s000711451300161x ◽

2013 ◽

Vol 110 (12) ◽

pp. 2234-2241 ◽

Cited By ~ 44

Author(s):

Rouyanne T. Ras ◽

Peter L. Zock ◽

Yvonne E. M. P. Zebregs ◽

Neil R. Johnston ◽

David J. Webb ◽

...

Keyword(s):

Blood Pressure ◽

Platelet Aggregation ◽

Ambulatory Blood Pressure ◽

Plasma Renin ◽

Grape Seed Extract ◽

Grape Seed ◽

Seed Extract ◽

Stage I ◽

Double Blind ◽

Dietary Polyphenols

Dietary polyphenols, such as those from grape products, may exert beneficial effects on cardiovascular health, including anti-hypertensive effects. We investigated the effect of a specific grape seed extract (GSE) rich in low-molecular-weight polyphenolic compounds on ambulatory blood pressure (ABP) in untreated subjects with pre- and stage I hypertension. In addition, potential mechanisms that could underlie the hypothesised effect of GSE on blood pressure (BP), and platelet aggregation, were explored. The study was designed as a double-blind, placebo-controlled, randomised, parallel-group intervention study including seventy healthy subjects with systolic BP between 120 and 159 mmHg. A 1-week run-in period was followed by an 8-week intervention period, during which subjects consumed capsules containing either 300 mg/d of GSE or a placebo (microcrystalline cellulose). Before and after the intervention, daytime ABP readings, 24 h urine samples and fasting and non-fasting blood samples were taken. The mean baseline systolic BP was 135·8 (se 1·3) mmHg and diastolic BP was 81·5 (se 0·9) mmHg. BP values were modestly, but not significantly, affected by the polyphenol-rich GSE treatment v. placebo with an effect of − 3·0 mmHg for systolic BP (95 % CI − 6·5, 0·5) and − 1·4 mmHg for diastolic BP (95 % CI − 3·5, 0·6). Vasoactive markers including endothelin-1, NO metabolites and asymmetric dimethylarginine, plasma renin activity and platelet aggregation were not affected by the GSE intervention. Our findings show that consumption of polyphenol-rich GSE does not significantly lower ABP in untreated subjects with pre- and stage I hypertension.

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A Clinical Study on the Correlation between Gastrointestinal Symptoms, Depression, and Anxiety in Patients with Irritable Bowel Syndrome

The Journal of Internal Korean Medicine ◽

10.22246/jikm.2019.40.4.629 ◽

2019 ◽

Vol 40 (4) ◽

pp. 629-636

Author(s):

Bong-soo Hur ◽

Seo-hyung Choi ◽

Yeoung-su Lyu

Keyword(s):

Irritable Bowel Syndrome ◽

Clinical Study ◽

Gastrointestinal Symptoms ◽

Depression And Anxiety ◽

Irritable Bowel

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Dissolution Study on Grape Polyphenol Hard Gelatin Capsule Dietary Supplements

Frontiers in Nutrition ◽

10.3389/fnut.2021.780260 ◽

2021 ◽

Vol 8 ◽

Author(s):

Weiting Lyu ◽

Thamer Omar ◽

Harna Patel ◽

David Rodriguez ◽

Mario G. Ferruzzi ◽

...

Keyword(s):

Dietary Supplements ◽

High Performance ◽

Grape Seed ◽

Acetate Buffer ◽

Dissolution Profile ◽

Dissolution Study ◽

Marker Compounds ◽

Dissolution Apparatus ◽

Hcl Medium ◽

States Pharmacopeia

Methods for a dissolution study by ultra-high performance liquid chromatography/triple quadrupole mass spectrometry (UHPLC-QqQ/MS) analysis of grape polyphenol dietary supplements, namely, grape seed extract (GSE) and resveratrol (RSV) capsules, were developed following the guidance of United States Pharmacopeia (USP) <2040>. Two dissolution media, 0.1 N hydrochloric acid (pH 1.2) and 0.05 M acetate buffer (pH 4.6), were evaluated with dissolution apparatus (USP 1), 100 rpm rotation speed, and 900 ml dissolution medium volume. Dissolution profiling was performed over 120 min. Major phenolic compounds of gallic acid, catechin, epicatechin, and procyanidin B2 were quantitated to obtain the dissolution profile of GSE capsules, and trans-RSV was used for RSV capsules. Results indicated that the released trans-RSV for RSV capsules in both of the dissolution media meets the USP standards, and that for the GSE capsules, all the four marker compounds passed the dissolution test in the HCl medium but did not reach a 75% release within 60 min in the acetate buffer. These promising results suggest that the general USP dissolution protocols are adequate for the successful release of RSV capsules in HCl medium and acetate buffer and GSE capsules (in HCl medium), but may be inadequate for GSE capsules in acetate buffer. These results showed that under a low pH of 1.2 (simulated stomach environment), bioactive compounds were released on time from the GSE capsules and met the USP guidelines; however, under a higher pH of 4.6 (simulated duodenum environment), the same biomarkers failed, suggesting the need to further improve the dissolution of GSE over a wider range of pH environments to enhance bioavailability and efficacy.

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Efectos del secado al aire y solar sobre la calidad nutricional del aceite, las semillas y pieles de las uvas Muscat Hamburg

Grasas y Aceites ◽

10.3989/gya.0341181 ◽

2018 ◽

Vol 69 (4) ◽

pp. 277

Author(s):

L. Tașeri ◽

M. Gülcü ◽

I. Palabiyik ◽

G. U. Seçkin ◽

T. Aktas ◽

...

Keyword(s):

Water Activity ◽

Antioxidant Activities ◽

Grape Juice ◽

Grape Seed ◽

Grape Pomace ◽

Drying Methods ◽

Grape Seed Oil ◽

Optimum Separation ◽

Fatty Acid Compositions

Grape pomace is an agro-industrial by-product from the production of must (grape juice) by pressing whole grapes. In order to evaluate the seeds and skins of the grape pomace, it must first be dried and then separated in a screen machine. The drying of pomace is an important and necessary process for the optimum separation of seeds. The main purpose of this study was to determine the optimum drying process for obtaining high-quality grape seed oil. In this research, open air and solar energy drying methods were compared in terms of water activity, total bacterial and mold-yeast count, along with the chemical and fatty acid compositions of pressed grape residues. Oleic acid and linoleic acid contents ranged from 16.56-16.96% and 71.45-71.96%, respectively. Antioxidant activities ranged from 2.33-2.80 μmol trolox/g. The results showed that the drying methods did not decrease the nutritional quality of grape residues and prevented microbial growth by decreasing water activity to below 0.60.

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The Role of Dietary Supplements in Depression and Anxiety – A Narrative Review

Pharmacopsychiatry ◽

10.1055/a-0942-1875 ◽

2019 ◽

Vol 52 (06) ◽

pp. 261-279 ◽

Cited By ~ 2

Author(s):

Knut Hoffmann ◽

Barbara Emons ◽

Stefan Brunnhuber ◽

Sedya Karaca ◽

Georg Juckel

Keyword(s):

Psychiatric Disorders ◽

Dietary Supplements ◽

Psychiatric Treatment ◽

Practical Knowledge ◽

Current Knowledge ◽

German Society ◽

Narrative Review ◽

Depression And Anxiety ◽

The Impact

Abstract Introduction Dietary supplements are very widely used in the general population and there is a growing market for them, which is against the recommendations of the German Society for Nutrition. There is some evidence that dietary supplements are useful additions in the treatment of psychiatric disorders. This review is an overview of available practical knowledge regarding the use of supplements in psychiatric treatment. In particular, the review focused on the diagnosis of depression and anxiety in terms of supplement treatment. Methods This is a narrative review of the evidence regarding supplements for treating anxiety and depression. We searched PubMed to 2018. Two reviewers screened the citations and abstracted the data. Phytopharmaceutical attends and animal-based data were excluded. Results There are strong indications regarding the impact of supplements on the selected psychiatric disorders, but at this time, there only a few randomized clinical studies available, so evidence for these findings is quite low. However, it must be noted that there are strong hints for a relationship between vitamin D level and depression. Furthermore, various supplements have got potentially an influence on the characteristics of depression. Discussion This review summarizes the current knowledge about supplements when used for some psychiatric conditions, but the data does not provide compelling evidence in any direction. There are only indications that there is an influence of supplements on psychiatric diseases. In support of this, there is further need for high-quality studies in this field. Reviews on other diagnoses, such as schizophrenia and dementia, will be part of further work.

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Modeling Interactions Between Latent Variables in Research on Type D Personality: A Monte Carlo Simulation and Clinical Study of Depression and Anxiety

Multivariate Behavioral Research ◽

10.1080/00273171.2018.1562863 ◽

2019 ◽

Vol 54 (5) ◽

pp. 637-665

Author(s):

Paul Lodder ◽

Johan Denollet ◽

Wilco H. M. Emons ◽

Giesje Nefs ◽

Frans Pouwer ◽

...

Keyword(s):

Monte Carlo Simulation ◽

Monte Carlo ◽

Clinical Study ◽

Latent Variables ◽

Type D Personality ◽

Depression And Anxiety ◽

Type D ◽

Modeling Interactions

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Effect of different splitting techniques on the characteristics of divided tablets of five commonly split drug products in Jordan

Pharmacy Practice ◽

10.18549/pharmpract.2020.2.1776 ◽

2020 ◽

pp. 1776

Author(s):

Shadi F. Gharaibeh ◽

Linda Tahaineh

Keyword(s):

Standard Deviation ◽

Relative Standard Deviation ◽

The Other ◽

Crushing Strength ◽

Percentage Score ◽

Drug Products ◽

Weight Variation ◽

Relative Standard ◽

Uniformity Test ◽

Better Than

Objective: To determine the accuracy, variability, and weight uniformity of tablet subdivision techniques utilized to divide the tablets of five drug products that are commonly prescribed for use as half tablets in Jordan. Methods: Ten random tablets of five commonly subdivided drug products were weighed and subdivided using three subdivision techniques: hand breaking, kitchen knife, and tablet cutter. The five commonly subdivided drug products (warfarin 5 mg, levothyroxine 50 μg, levothyroxine 100 μg, candesartan 16 mg, and carvedilol 25 mg) were weighed. The weights were analyzed for acceptance, accuracy, and variability. Weight variation acceptance criteria were adopted in this work as a tool to indicate the properness of the subdivision techniques used to produce acceptable half tablets. Other relevant physical characteristics of the five products such as tablet shape, dimensions, face curvature, score depth, and crushing strength were measured. Results: All tablets were round in shape, had weights that ranged between 100.63 mg (standard deviation=0.99) and 379.04 mg (standard deviation=3.00), and had crushing strengths that ranged between 23.29 N (standard deviation=3.58)and 103.35 N (standard deviation=14.98). Both candesartan and carvedilol were bi-convex in shape with an extent of face curvature equal to about 33%. In addition, percentage score depth of the tablets had a range between 0% and 24%. The accuracy and variability of subdivision varied according to the subdivision technique used and tablet characteristics. Accuracy range was between 81% and 109.8%. Moreover, the relative standard deviation was between 1.5% and 17.4%. Warfarin 5 mg subdivided tablets failed the weight variation test regardless of the subdivision technique used. Subdivision by hand produced half tablets that were acceptable for levothyroxine 50 μg and levothyroxine 100 μg. Subdivision by knife produced half tablets that were acceptable only for candesartan tablets. However, the tablet cutter produced half tablets that passed the weight variation test for four out of the five drug products tested in this study. Conclusions: The tablet cutter performed better than the other subdivision techniques used. It produced half tablets that passed the weight uniformity test for four drug products out of the five.

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