RESVERATROL

Notes

• Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
• The solidus (/) indicates that the terms and/or statements are synonymous. Either term or statement may be selected by the applicant.

Date

August 28, 2018

Proper name(s), Common name(s), Source material(s)

References: Proper names: PubChem 2018; O'Neil 2013, Common name: O'Neil 2013; Source materials: USDA 2018, O'Neil 2013, La Porte et al. 2010, Bertelli and Das 2009, Dani et al. 2007.

Route of Administration

Oral

Dosage Form(s)

This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

Acceptable dosage forms for the age category listed in this monograph and specified route of administration are indicated in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

(Provides) An antioxidant (Ghanim et al. 2010; Rocha et al. 2009).

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Not to exceed 1 gram of resveratrol, per day (Cottart et al. 2013; Brown et al. 2010; Gaby 2006).

Direction(s) for use

No statement required.

Duration(s) of Use

Products providing more than 250 mg of resveratrol, per day

Consult a health care practitioner/health care provider/health care professional/doctor/physician for prolonged use (Vang et al. 2010).

Risk Information

Caution(s) and warning(s)

• Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you are pregnant or breastfeeding.
• Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you are taking prescription medications as resveratrol may alter the effectiveness of these medications (Bransyo et al. 2011; Chow et al. 2010).

Contraindication(s)

No statement required.

Known adverse reaction(s)

Products providing 500 mg or more of resveratrol, per day

May cause nausea, abdominal pain, and/or diarrhea (Brown et al. 2010; Chow et al. 2010).

Non-medicinal ingredients

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

Storage conditions

No statement required.

Specifications

• The finished product specifications must be established in accordance with the requirements described in the Natural and Non-prescription Health Products Directorate (NNHPD) Quality of Natural Health Products Guide.
• The medicinal ingredient must comply with the requirements outlined in the NHPID.

References cited

• Bertelli AA, Das DK. Grapes, wines, resveratrol, and heart health. Journal of Cardiovascular Pharmacology 2009;54(6):468-476.
• Brasnyó P, Molnár GA, Mohás M, Markó L, Laczy B, Cseh J, Mikolás E, Szijártó IA, Mérei A, Halmai R, Mészáros LG, Sümegi B, Wittmann. Resveratrol improves insulin sensitivity, reduces oxidative stress and activates the Akt pathway in type 2 diabetic patients. British Journal of Nutrition 2011;106(3):383-389.
• Brown VA, Patel KR, Viskaduraki M, Crowell JA, Perloff M, Booth TD, Vasilinin G, Sen A, Schinas AM, Piccirilli G, Brown K, Steward WP, Gescher AJ, Brenner DE. Repeat Dose Study of the Cancer Chemopreventive Agent Resveratrol in Healthy Volunteers: Safety, Pharmacokinetics, and Effect on the Insulin-like Growth Factor Axis. Cancer Research 2010; 70(22):9003-9011.
• Chow HH, Garland LL, Hsu CH, Vining DR, Chew WM, Miller JA, Perloff M, Crowell JA, Alberts DS. Resveratrol Modulates Drug- and Carcinogen-Metabolizing Enzymes in a healthy Volunteer Study. Cancer Prevention Research 2010;3:1168-1175.
• Cottart CH, Nivet-Antoine V, Beaudeux JL.Review of recent data on the metabolism, biological effects, and toxicity of resveratrol in humans. Molecular Nutrition & Food Research 2013;Epub 1-15.
• Dani C, Oliboni LS, Vanderlinde R, Bonatto D, Salvador M, Henriques JA. Phenolic content and antioxidant activities of white and purple juices manufactured with organically- or conventionally-produced grapes. Food and Chemical Toxicology 2007;45(12):2574-2580.
• Gaby A. The Natural Pharmacy, 3rd edition. Healthnotes Inc.;2006.
• Ghanim H, Sia CL, Abuaysheh S, Korzeniewski K, Patnaik P, Marumganti A, Chaudhuri A, Dandona P. An anti-inflammatory and Reactive Oxygen Species Suppressive Effects of an Extract of Polygonum Cuspidatum Containing Resveratrol. Journal of Clinical Endocrinology & Metabolism 2010;95(9):E1-E8.
• La Porte C, Voduc N, Zhang G, Seguin I, Tardiff D, Singhal N, Cameron DW. Steady-State Pharmacokinetics and Tolerability of Trans-Resveratrol 2000 mg Twice Daily with Food, Quercetin and Alcohol (Ethanol) in Healthy Human Subjects. Clinical Pharmacokinetics 2010;49(7):449-454.
• O'Neil MJ, Smith A, Heckelman PE, Budavari S, editors. The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals, 15th edition. Whitehouse Station (NJ): Merck & Co., Inc.; 2013.
• PubChem 2018: PubChem Substance Database; National Center for Biotechnology Information. Chemicals & Bioassays. U.S. National Library of Medicine. [Internet]. [Accessed 2018 June 18]. Available from : http://www.ncbi.nlm.nih.gov/pcsubstance?cmd=search
• Rocha KK, Souza GA, Ebaid GX, Seiva FR, Cataneo AC, Novelli EL. Resveratrol toxicity: Effects on risk factors for atherosclerosis and hepatic oxidative stress in standard and high-fat diets. Food and Chemical Toxicology 2009;47(6):1362-1367.
• USDA 2018: ARS, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2018 June 18]. Available at: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
• Vang, O. What is new for resveratrol? Is a new set of recommendations necessary? Annals of the New York Academy of Sciences 2013;1290(1):1-11.

References reviewed

• Baxter RA. Anti-aging properties of resveratrol: review and report of a potent new antioxidant skin care formulation. Journal of Cosmetic Dermatology 2008;7(1):2-7.
• Bishayee A. Cancer Prevention and Treatment with Resveratrol: From Rodent Studies to Clinical Trials. Cancer Prevention Research Published Online First;2009.
• Boocock DJ, Faust GE, Patel KR, Schinas AM, Brown VA, Ducharme MP, Booth TD, Crowell JA, Perloff M, Gescher AJ, Steward WP, Brenner DE. Phase I dose escalation pharmacokinetic study in healthy volunteers of resveratrol, a potential cancer chemopreventive agent. Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology 2007;16:1246-1252.
• Boocock DJ, Patel KR, Faust GE, Normolle DP, Marczylo TH, Crowell JA, Brenner DE, Booth TD, Gescher A, Steward WP.Quantitation of trans-resveratrol and detection of its metabolites in human plasma and urine by high performance liquid chromatography. Journal of chromatography. B, Analytical technologies in the biomedical and life sciences 2007;848:182-187.
• ChemID 2012: National Institutes of Health. ChemIDplus advanced [online]. 2011. Resveratrol. ChemIDplus Advanced Bethesda (MD): Specialized Information Services, United States National Library of Medicine, National Institutes of Health, United States Department of Health & Human Services. [Accessed 2011 May 9].
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• Hogan S, Canning C, Sun S, Sun X, Zhou K. Effects of Grape Pomace Antioxidant Extract on Oxidative Stress and Inflammation in Diet Induced Obese Mice. Journal of Agriculture and Food Chemistry 2010;58(21):11250-11256.
• Kennedy DO, Wightman EL, Reay JL, Lietz G, Okello EJ, Wilde A, Haskell CF. Effects of resveratrol on cerebral blood flow variables and cognitive performance in humans: a double-blind, placebo-controlled, crossover investigation. The American journal of clinical nutrition 2010; 91:1590-1597.
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• Meng X, Maliaki P, Lu H, Lee M-J, Yang CS.Urinary and plasma levels of resveratrol and quercetin in humans, mice, and rats after ingestion of pure compounds and grape juice. Journal of Agriculture and Food Chemistry 2004;52:935-942.
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• Puizina-Ivic N, Miric L, Carija A, Karlica D, Marasovic D. Modern approach to topical treatment of aging skin. Collegium antropologicum 2010;34(3):1145-1153.
• Soleas GJ, Yan J, Goldberg DM. Ultrasensitivity assay for the three polyphenols (catechin, quercetin and resveratrol) and their conjugates in biological fluids utilizing gas chromatography with mass selective detection. Journal of chromatography. B, Analytical technologies in the biomedical and life sciences 2002;757:161-172.
• Toklu HZ, Sehirli O, Ersahin M, Süleymanoglu S, Yiginer O, Emekli-Alturfan E, Yarat A, Yegen BÇ, Sener G. Resveratrol improves cardiovascular function and reduces oxidative organ damage in the renal, cardiovascular and cerebral tissues of two-kidney, one-clip hypertensive rats. The Journal of pharmacy and pharmacology 2010;62(12):1784-1793.
• Vitaglione P, Sforza S, Galaverna G, Ghidini C, Caporaso N, Vescovi PP, Fogliano V, Marchelli R. Bioavailability of trans-resveratrol from red wine in humans. Molecular nutrition and food research 2005;49:495-504.
• Walle T, Hsieh F, DeLegge MH, Oatis JE, Walle UK. High absorption but very low bioavailability of oral resveratrol in humans. Drug metabolism and disposition: the biological fate of chemicals.2004;32:1377-1382.
• Wang J, He D, Zhang Q, Han Y, Jin S, Qi F. Resveratrol Protects Against Cisplatin-Induced Cardiotoxicity by Alleviating Oxidative Damage. Cancer biotherapy and radiopharmaceuticals, 2009;24(6):675-680.
• Wood LG, Wark PA, Garg ML. Antioxidant and anti-inflammatory effects of resveratrol in airway disease. Antioxid Redox Signal 2010 Nov 15;13(10):1513-1515.
• Zamora-Ros R, Urpí-Sardà M, Lamuela-Raventós RM, Estruch R, Vázquez-Agell M, Serrano-Martínez M, Jaeger W, Andres-Lacueva C. Diagnostic performance of urinary resveratrol metabolites as a biomarker of moderate wine consumption.Clinical Chemistry 2006;52:1373-80.
• Zern TL, Wood RJ, Greene C, West KL, Liu Y, Aggarwal D, Shachter NS, Fernandez ML. Grape Polyphenols Exert a Cardioprotective Effect in Pre- and Postmenopausal Women by Lowering Plasma Lipids and Reducing Oxidative Stress. Journal of Nutrition 2005;135:1911-1917.