GREEN COFFEE BEAN EXTRACT

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.

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)

Table 1. Proper name(s), Common name(s), Source material(s)

Proper name(s)	Common name(s)	Source material(s)
		Proper name(s)	Part(s)
Green coffee bean extract	Green coffee bean extract	Coffea arabica Coffea canephora	Seed

References: Proper name: Kozuma et al. 2005; Common name: Kozuma et al. 2005; Source materials: USDA 2018, Thom 2007, Kozuma et al. 2005.

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)

• Could (be a) complement to a healthy lifestyle that incorporates a calorie-reduced diet and regular physical activity for individuals involved in a weight management program (Thom 2007; Dellalibera et al. 2006).
• Helps maintain healthy blood pressure levels (Mubarak et al. 2012; Watanabe et al. 2006; Kozuma et al. 2005).
• Helps support cardiovascular health (Mubarak et al. 2012; Watanabe et al. 2006; Kozuma et al. 2005).
• Source of/Provides antioxidants (Farah et al. 2008; Castellucio et al. 1995).

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Antioxidant

Methods of preparation: Standardized extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

Not to exceed 1000 milligrams of extract per day, standardized to 45-50% chlorogenic acids and up to 4% of caffeine (Thom 2007).

Weight Management

Methods of preparation: Standardized extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

400 - 1000 milligrams of extract per day, standardized to 45-50% chlorogenic acids and up to 4% caffeine (Thom 2007; Dellalibera et al. 2006).

Blood pressure; Cardiovascular health

Methods of preparation: Standardized extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

115 - 1000 milligrams of extract per day, standardized to 45-50% chlorogenic acids and up to 4% caffeine (Thom 2007; Watanabe et al. 2006; Kozuma et al. 2005).

Note

For Blood pressure and/or Cardiovascular health claims: Green coffee bean extract (maximum 4% caffeine) cannot be combined with caffeine or other medicinal or non-medicinal ingredients containing caffeine.

Direction(s) for use

No statement required.

Duration(s) of Use

No statement required.

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 breastfeeding.

Contraindication(s)

Do not use this product if you are pregnant.

Known adverse reaction(s)

No statement required.

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

• Castelluccio C, Paganga G, Melikian N, Bolwell GP, Pridham J, Sampson J, Rice-Evans C. Antioxidant potential of intermediates in phenylpropanoid metabolism in higher plants. FEBS Letters 1995;368(1):188-192. 
• Dellalibera O, Lemaire B and Lafay S. Svetol®, green coffee extract, induces weight loss and increases lean to fat ratio in volunteers with overweight problems. Phytotherapie 2006;4(4):194–197.
• Farah A, Monteiro M, Donangelo CM, Lafay S. Chlorogenic acids from green coffee extract are highly bioavailable in humans. The Journal of Nutrition 2008;138:2309-2315.
• Kozuma K, Tsuchiya S, Kohori J, Hase T and Tokimitsu I. Antihypertensive effect of green coffee bean extract on mildly hypertensive subjects. Hypertension Research: Official Journal of the Japanese Society of Hypertension 2005;28(8):711-718. 
• Mubarak A, Bondonno CP, Liu AH, Considine MJ, Rich L, Mas E, Croft KD, Hodgson JM. Acute effects of chlorogenic acid on nitric oxide status, endothelial function, and blood pressure in healthy volunteers: a randomized trial. Journal of Agricultural and Food Chemistry 2012;60:9130-9136. 
• Thom E. The Effect of Chlorogenic Acid Enriched Coffee on Glucose Absorption in Healthy Volunteers and Its Effect on Body Mass When Used Long-term in Overweight and Obese People. The Journal of International Medical Research 2007;35(6):900-908.
• USDA 2018: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program.Germplasm Resources Information Network (GRIN). [Internet]. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2018 June 29]. Available from:  http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
• Watanabe T, Arai Y, Mitsui Y, Kusaura T, Okawa W, Kajihara Y, Saito I. The blood pressure-lowering effect and safety of chlorogenic acid from green coffee bean extract in essential  hypertension. Clinical and Experiemntal Hypertension 2006;28(5):439-449. 

References reviewed

• Blum J, Lemaire B, and Lafay S. Effect of a green decaffeinated coffee extract on glycemia - A pilot prospective clinical study. NUTRAfoods 2007;6(3):13-17. 
• Farah A, Monteiro M, Donangelo CM, Lafay S. Chlorogenic acids from green coffee extract are highly bioavailable in humans. The Journal of Nutrition 2008;138:2309-2315. 
• Henry-Vitrac C, Ibarra A, Roller M, Mérillon JM, Vitrac X. Contribution of chlorogenic acids to the inhibition of human hepatic glucose-6-phosphatase activity in vitro by Svetol, a standardized decaffeinated green coffee extract. Journal of Agricultural and Food Chemistry 2010;58:4141-4144. 
• Ochiai R, Jokura H, Suzuki A, Tokimitsu I, Ohishi M, Komai N, Rakugi H, Ogihara T. Green coffee bean extract improves human vasoreactivity. Hypertension Research 2004;27(10):731-737. 
• Olthof MR, Hollmann PCH and Katan MB. Chlorogenic acid and caffeic acid are absorbed in humans. The Journal of Nutrition 2001;131:66-71. 
• Yamaguchi T, Chikama A, Mori K, Watanabe T, Shioya Y, Katsuragi Y, Tokimitsu I. Nutrition, Metabolism & Cardiovascular Diseases 2008;18:408-414.