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Drugs and Health Products

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 the statements are synonymous. Either term or statement may be selected by the applicant.

Date

September 27, 2013

Proper name(s)

Beta-glucan (Charlton et al. 2012; Queenan et al. 2007; Braaten et al. 1994; Uusitupa et al. 1992)

Common name(s)

Beta-glucan (Charlton et al. 2012; Queenan et al. 2007; Braaten et al. 1994; Uusitupa et al. 1992)

Source material(s)

  • Avena sativa L. (oat) (USDA 2008) seed and/or seed bran (Charlton et al. 2012; Queenan et al. 2007)
  • Hordeum vulgare L. (barley) (USDA 2010) seed and/or seed bran (Queenan et al. 2007)

Route(s) 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

  • Helps reduce/lower (LDL) cholesterol (which is one risk factor for the development of coronary heart disease) (Charlton et al. 2012; EFSA 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) (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) (Ulmius et al 2011; Granfeldt et al. 2008; Panahi et al. 2007; Biorklund et al. 2005; Kabir et al. 2002).
  • Source of dietary fiber to help support and maintain a healthy digestive system (CFIA 2012; IOM 2005).
  • Helps support and maintain a healthy digestive system (CFIA 2012; IOM 2005).

Dose

Subpopulation(s)

Adults (≥ 18 years)
Quantity(ies)

3-10 g oat beta-glucan, per day (Charlton et al. 2011; Queenan et al. 2007; Johnston et al. 1998; Braaten et al. 1994; Torronen et al. 1992; Uusitupa et al. 1992)

Directions for use

No statement required.

Duration 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 NNHPD Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Storage conditions

Statement(s) to the effect of

Preserve in well-closed containers (USP 35).

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the NNHPD Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredients Database (NHPID). In addition, the medicinal ingredient may comply with the specifications outlined in the United States Pharmacopeia monograph Colloidal Oatmeal (USP 35).

References cited

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