BETA-GLUCAN

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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

June 3, 2019

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)	Preparation
Beta-glucan	beta-glucan beta-D-glucan	Avena sativa Hordeum vulgare	Seed Seed bran	Isolate
	Oat beta-glucan	Avena sativa

References: Proper name: Charlton et al. 2012; EFSA 2011a,b,2010; Queenan et al. 2007; Braaten et al. 1994; Uusitupa et al. 1992; Common names: Charlton et al. 2012; EFSA 2011a,b,2010; Queenan et al. 2007; Braaten et al. 1994; Uusitupa et al. 1992; Source materials: USDA 2019a,b, Charlton et al. 2012, Queenan 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 any age category listed in this monograph for the specified route of administration are listed in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

• Helps reduce/lower (LDL) cholesterol (which is one risk factor for the development of coronary heart disease) (Charlton et al. 2012; EFSA 2011a,b,2010; AbuMweiss et al. 2010; HC 2010; Wolever et al. 2010; Delahoy et al. 2009; Queenan et al. 2007; Wood 2007; Biorklund et al. 2005; NECP 2002; Brown et al. 1999; Ripsin et al. 1992).
• Provides support for healthy (postprandial) glucose metabolism (within two hours after a meal) (EFSA 2011a,b; Ulmius et al. 2011; Granfeldt et al. 2008; Panahi et al. 2007; Biorklund et al. 2005; Kabir et al. 2002).
• Helps improve (postprandial) glucose metabolism (within two hours after a meal) (EFSA 2011a,b; Ulmius et al 2011; Granfeldt et al. 2008; Panahi et al. 2007; Biorklund et al. 2005; Kabir et al. 2002).
• Source of fiber for the maintenance of good health (CFIA 2012; IOM 2005).
• Helps support and maintain a healthy digestive system (CFIA 2012; IOM 2005).

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

2 - 10 grams of Beta-glucan, per day (Charlton et al. 2011; EFSA 2011a,b.2010; AbuMweiss et al. 2010; Queenan et al. 2007; IOM 2005; Johnston et al. 1998; Braaten et al. 1994; Torronen et al. 1992; Uusitupa et al. 1992).

Direction(s) for use

No statement required.

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

No statement required.

Contraindication(s)

No statement required.

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

Preserve in well-closed containers (USP 35 2012).

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

• AbuMweis SS, Jew S, Ames NP. Beta-glucan from barley and its lipid lowering capacity: a meta-analysis of randomized, controlled trials. European Journal of Clinical Nutrition 2010;64:1472-1480.
• Biorklund M, van Rees A, Mensink RP, Onning G. Changes in serum lipids and postprandial glucose and insulin concentrations after consumption of beverages with beta-glucans from oats or barley: a randomised dose-controlled trial. European Journal of Clinical Nutrition 2005;59(11):1272-1281.
• Braaten JT, Wood PJ, Scott FW, Wolynetz MS, Lowe MK, Bradley-White P, Collins MW. Oat beta-glucan reduces blood cholesterol concentration in hypercholesterolemic subjects. European Journal of Clinical Nutrition 1994;48(7):465-474.
• Brown L, Rosner B, Willett WW, Sacks FM. Cholesterol-lowering effects of dietary fiber: a meta-analysis. American Journal of Clinical Nutrition 1999;69(1):30-42.
• CFIA 2012: Canadian Food Inspection Agency, Guide to Food Labelling and Advertising,
• Chapter 6: The Elements Within the Nutrition Facts Table Section 6.8.1 Dietary Fibre. [Accessed 2019 May 13]. Available from: http://www.inspection.gc.ca/english/fssa/labeti/guide/ch6ae.shtml
• Charlton KE, Tapsell LC, Batterham MJ, O'Shea J, Thorne R, Beck E, Tosh SM. Effect of 6 weeks' consumption of ?-glucan-rich oat products on cholesterol levels in mildly hypercholesterolaemic overweight adults. British Journal of Nutrition 2012;107:1037-1047.
• Delahoy PJ, Magliano DJ, Webb K, Grobler M, Liew D. The relationship between reduction in low-density lipoprotein cholesterol by statins and reduction in risk of cardiovascular outcomes: an updated meta-analysis. Clinical Therapeutics 2009;31(2):236-244.
• EFSA 2010: Scientific Opinion: Scientific Opinion on the substantiation of a health claim related to oat beta-glucans and lowering blood cholesterol and reduced risk of (coronary) heart disease pursuant to Article 14 of Regulation (EC) No 1924/2006. [Internet]. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), European Food Safety Authority (EFSA), Parma, Italy. [Accessed 2019 May 13]. Available from: http://www.efsa.europa.eu/en/efsajournal/doc/1885.pdf
• EFSA 2011a: Scientific Opinion: Scientific Opinion on the substantiation of health claims related to beta-glucans from oats and barley and maintenance of normal blood LDL-cholesterol concentrations (ID 1236, 1299), increase in satiety leading to a reduction in energy intake (ID 851, 852), reduction of post-prandial glycaemic responses (ID 821, 824), and 'digestive function' (ID 850) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. [Internet]. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), European Food Safety Authority (EFSA), Parma, Italy. [Accessed 2019 May 13]. Available from: http://www.efsa.europa.eu/en/efsajournal/doc/2207.pdf
• EFSA 2011b: Scientific Opinion: Scientific Opinion on the substantiation of a health claim related to barley beta-glucans and lowering of blood cholesterol and reduced risk of (coronary) heart disease pursuant to Article 14 or Regulation (EC) No 1924/2006. [Internet]. EFSA Panel on Dietetic Products, Nutrition and Allergies (DNA), European Food Safety Authority (EFSA), Parma, Italy. [Accessed 2019 May 13]. Available from: http://www.efsa.europa.eu/en/efsajournal/doc/2471.pdf
• Granfeldt Y, Nyberg L, Bjorck I. Muesli with 4 g oat beta-glucans lowers glucose and insulin responses after a bread meal in healthy subjects. European Journal of Clinical Nutrition 2008;62(5):600-607.
• HC 2010. Oat Products and Blood Cholesterol Lowering; Summary of Assessment of a Health Claim about Oat Products and Blood Cholesterol Lowering. [Accessed 2019 May 13]. Available from: http://www.hc-sc.gc.ca/fn-an/label-etiquet/claims-reclam/assess-evalu/oat-avoine-eng.php
• IOM 2005: Institute of Medicine of the National Academies. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Food and Nutrition Board. [Accessed 2019 May 13]. Available from: http://www.nap.edu/openbook.php?record_id=10490&page=680
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• Queenan KM, Stewart ML, Smith KN, Thomas W, Fulcher RG, Slavin JL. Concentrated oat ?- glucan, a fermentable fiber, lowers serum cholesterol in hypercholesterolemic adults in a randomized controlled trial. Nutrition Journal 2007;6:1-8.
• Ripsin CM, Keenan JM, Jacobs DR Jr, Elmer PJ, Welch RR, Van Horn L, Liu K, Turnbull WH, Thye FW, Kestin M, Hegsted M, Davidson DM, Davidson MH, Dugan LD, Wahnefried WD, Beling S. Oat products and lipid lowering. A meta-analysis. Journal of the American Medical Association 1992;267(24):3317-3325.
• Torronen R, Kansanen L, Uusitupa M, Hanninen O, Myllymaki O, Harkonen H, Malkki Y. Effects of an oat bran concentrate on serum lipids in free-living men with mild to moderate hypercholesterolaemia. European Journal of Clinical Nutrition 1992;46(9):621-627.
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• USDA 2019a: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). [Internet]. Hordeum vulgare (L). National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2019 May 02]. Available from:
• https://npgsweb.ars-grin.gov/gringlobal/taxonomybrowse.aspx
• USDA 2019b: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). [Internet]. Avena sativa (L). National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2019 May 13]. Available from:
• https://npgsweb.ars-grin.gov/gringlobal/taxonomybrowse.aspx
• USP 35: The United States Pharmacopeia and the National Formulary (USP 35/NF 30). Rockville (MD): United States Pharmacopeial Convention, Inc.; 2012.
• Uusitupa MI, Ruuskanen E, Makinen E, Laitinen J, Toskala E, Kervinen K, Kesaniemi YA. A controlled study on the effect of beta-glucan-rich oat bran on serum lipids in hypercholesterolemic subjects: relation to apolipoprotein E phenotype. Journal of American College of Nutrition 1992;11(6):651-659.
• Wolever TMS, Tosh SM, Gibbs AL, Brand-Miller J, Duncan AM, Hart V, Lamarche B, Thomson BA, Duss R, Wood PJ. Physicochemical properties of oat ?-glucan influence its ability to reduce serum LDL cholesterol in humans: a randomized clinical trial. American Journal of Clinical Nutrition 2010;92(4):723-732.
• Wood P. Cereal ?-glucans in diet and health. Journal of Cereal Science 2007;46(3):230-238.

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