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Drugs and Health Products

Monograph: Grape Seed Extract

This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient. It is a referenced document to be used as a labelling standard. Note: Text in parentheses is additional optional information which can be included on the PLA and product labels at the applicants' discretion. The solidus (/) indicates that the terms are synonyms or that the statements are synonymous. Either term or statement may be selected by the applicant.

Date: 2009-06-24

NHPID Name

Grape seed extract (USDA 2008)

Proper Name(s)

Vitis vinifera L. (Vitaceae) ( USDA 2008 )

Common Name(s)

Grape seed extract ( Sano et al. 2007 )

Source Material

Seed ( Sano et al. 2007 , Henriet 1993 )

Route Of Administration

Oral

Dosage Form(s)

  • The acceptable pharmaceutical dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets.
  • This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of:

Dose(s)

Adults:

Antioxidant
Preparation: Dry & Powder Standardised

Dose(s): not to exceed 475 Milligrams per day, grape seed extract 80-85 Percent Oligomeric proanthocyanidins
Relief of symptoms related to non-complicated CVI
Preparation: Dry & Powder Standardised

Dose(s): 150 - 475 Milligrams per day, grape seed extract 80-85 Percent Oligomeric proanthocyanidins

See Appendix 1 for examples of appropriate dosage preparations and frequencies of use, according to cited references. The purpose of Appendix 1 is to provide guidance to industry.

Duration of use

Relief of symptoms related to non-complicated CVI: Use for a minimum of 1 month to see beneficial effects  (Thébaut et al. 1985, Delacroix 1981, Sarrat 1981)
Consult a health care practitioner for use beyond 3 months  (Sano et al. 2007)

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
  • Consult a health care practitioner prior to use if you are pregnant or breastfeeding
  • Relief of symptoms related to non-complicated CVI:
    Consult a health care practitioner if symptoms worsen

Contraindication(s):
No statement is required

Known Adverse Reaction(s):
No statement is required

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database and must meet the limitations outlined in the database.

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the NHPD Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredient Database (NHPID).

References cited

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  • Bagchi D, Garg A, Krohn L, Bagchi M, Bagchi DJ, Balmoori J, Stohs SJ. 1998. Protective effects of grape seed proanthocyanidins and selected antioxidants against TPA-induced hepatic and brain lipid peroxidation and DNA fragmentation, and peritoneal macrophage activation in mice. General Pharmacology 30(5):771-776
  • Delacroix P. 1981. [Double-blind study of Endotelon in chronic venous insufficiency.] Étude en double aveugle de l'endotelon dans l'insuffisance veineuse chronique. La Revue de Médecine 22(27-28):1793-1802 (in French)
  • Henriet JP. 1988. [EndotelonR in the functional disorders caused by peripheral vascular insufficiency.] EndotelonR dans les manifestations fonctionnelles de l'insuffisance veineuse périphérique: Étude EIVE. Actualité Médicales Internationales-Angiologie 5(74):167-170 (in French)
  • Henriet JP. 1993. [Veno-lymphatic insufficiency. 4 729 patients undergoing hormonal and procyanidol oligomer therapy.] Insuffisance veino-lymphatique 4 729 patientes sous thérapeutique hormonale et oligomères procyanidoliques. Phlébologie 46(2):313-325 (in French)
  • Natella F, Belelli F, Gentill V, Ursini F, Scaccini C. 2002. Grape seed proanthocyanidins prevent plasma postprandial oxidative stress in humans. The Journal of Agricultural and Food Chemistry 50(26):7720-7725
  • Sano A, Uchida R, Saito M, Shioya N, Komori Y, Tho Y, Hashizume N. 2007. Beneficial effects of grape seed extract on malondialdehyde-modified LDL. Journal of Nutritional Science and Vitaminology 53(2):174-182
  • Sarrat L. 1981. [Therapeutic relief of functional problems of the lower legs by Endotelon, a microangrioprotector.] Abord Thérapeutique des troubles fonctionnels des membres inférieurs par un microangrioprotecteur l'Endotelon. Bordeaux Médical 14:685-688 (in French)
  • Thébaut J-F, Thébaut P, Vin F. 1985. [Study of Endotelon in the functional manifestations of peripheral venous insufficiency. Results of a double-blind study of 92 patients.] Étude de l'Endotelon dans les manifestations fonctionelles de l'insuffisance veineuse périphérique. Résultats d'une étude en double aveugle portant sur 92 patients. Gazette Médicale 92(1):96-100 (in French)
  • USDA 2008: ARS, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2008-01-21]. Available at http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl

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Appendix 1: Examples of dosage preparations and frequencies of use

Antioxidant:

  • 555 mg grape seed extract, per day, standardized to 72% oligomeric proanthocyanidins (OPC) (Sano et al. 2007)
  • 300 mg grape seed extract, per day, standardized to 80-85% oligomeric proanthocyanidins (OPC) (Natella et al. 2002)

Relief of symptoms related to non-complicated CVI:

  • 150 mg grape seed extract, 2 times per day, standardized to 80-85% oligomeric proanthocyanidins (OPC) (Henriet 1993; Henriet 1988)
  • 50 mg grape seed extract, 3 times per day, standardized to 80-85% oligomeric proanthocyanidins (OPC) (Thébaut et al. 1985; Delacroix et al. 1981; Sarrat 1981)