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Drugs and Health Products

White Kidney Bean Extract - Phaseolus Vulgaris L. 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 the statements are synonymous. Either term or statement may be selected by the applicant.

Date

January 12, 2016

Proper name(s)

Phaseolus vulgaris L. (USDA 2010)

Common name(s)

White kidney bean (Barrett and Udani 2011; Wu et al. 2010; Udani et al. 2009; Vinson et al. 2009; Celleno et al. 2007; Udani and Singh 2007; Udani et al. 2004; Rothacker 2003; Facciola 1998)

Source material(s)

Seed

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:
  • Provides support for healthy (postprandial) glucose metabolism (within two hours after a meal) (Barrett and Udani 2011; Udani et al. 2009; Vinson et al. 2009; Boivin et al. 1987; Layer et al. 1986).
  • Helps improve (postprandial) glucose metabolism (within two hours after a meal) (Barrett and Udani 2011; Udani et al. 2009; Vinson et al. 2009; Boivin et al. 1987; Layer et al. 1986).
  • Helps reduce the (enzymatic) digestion of carbohydrates (Barrett and Udani 2011; Vinson et al. 2009; Layer et al. 1985; Boivin et al. 1987; Layer et al. 1986).
  • 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 (Wu et al. 2010; Celleno et al. 2007; Udani and Singh 2007; Udani et al. 2004; Rothacker 2003).

Dose(s)

Statement(s) to the effect of

Subpopulation(s)

Adults ( ≥ 18 years)

Quantity(ies)

All claims except weight management

1.5-3 g aqueous extract per day, standardised to 3000 alpha-amylase inhibiting units (AAIU) per gram (Barrett and Udani 2009; Udani et al. 2009; Vinson et al. 2009; Layer et al. 1985).

Weight management

1 g aqueous extract standardised to 3000 alpha-amylase inhibiting units (AAIU) per gram, three times per day (Wu et al. 2010; Celleno et al. 2007; Udani and Singh 2007; Udani et al. 2004; Rothacker 2003).

Note: Solvent used for extraction must be water only. On the electronic PLA form, indicate 'Extract dry standardized' as a method of preparation and 'Water 100%' in the solvent field.

Directions for use
Take before meals (Wu et al. 2010; Barrett and Udani 2009; Udani et al. 2009; Vinson et al. 2009; Celleno et al. 2007; Udani and Singh 2007; Udani et al. 2004; Rothacker 2003; Layer et al. 1985).

Duration of use

No statement required.

Risk information

Statement(s) to the effect of:

Caution(s) and warning(s)

  • If you are breastfeeding, consult a health care practitioner prior to use.
  • If you have diabetes, consult a health care practitioner prior to use (Buse 2000).

Contraindication(s)

If you are pregnant, do not use this product.

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)
  • Amount of hemagglutinating units (HU) should not exceed 645 HU per gram.
  • Amount of trypsin inhibitor units (TIU) should not exceed 20 TIU per milligram.

References cited

  • Barrett ML, Udani JK. A proprietary alpha-amylase inhibitor from white bean (Phaseolus vulgaris): A review of clinical studies on weight loss and glycemic control. Nutrition Journal 2011;10:24.
  • Boivin M, Zinsmeister AR, Go VL, DiMagno EP. Effect of a purified amylase inhibitor on carbohydrate metabolism after a mixed meal in healthy humans. Mayo Clinic Proceedings 1987;62:249-255.
  • Buse J. A symposium: combining insulin and oral agents. The American Journal of Medicine 2000;108:23S-32S.
  • Celleno L, Tolaini MV, D'Amore A, Perricone NV, Preuss HG. A dietary supplement containing standardized Phaseolus vulgaris extract influences body composition of overweight men and women. International Journal of Medical Sciences 2007;4(1):45-52.
  • Facciola S. Cornucopia II: A source book of edible plants. Vista (CA): Kampong Publications, 1998.
  • Layer P, Carlson GL and DiMagno EP. Partially purified white bean amylase inhibitor reduces starch digestion in vitro and inactivates intraduodenal amylase in humans. Gastroenterology 1985;88:1895-902.
  • Layer P, Zinsmeister AR, DiMagno EP. Effects of decreasing intraluminal amylase activity on starch digestion and postprandial gastrointestinal function in humans. Gastroenterology 1986;91:41-48.
  • Rothacker D. Next link will take you to another Web site Reduction in body weight with a starch blocking diet aid: Starch Away comparison with placebo. Leiner Health Products. 2003. [Internet]. [Accessed 2012 April 3].
  • Udani JK, Hardy M, Madsen DC. Blocking carbohydrate absorption and weight loss: a clinical trial using Phase 2 brand proprietary fractionated white bean extract. Alternative Medicine Review 2004;9(1):63-69.
  • Udani JK, Singh BB. Blocking carbohydrate absorption and weight loss: a clinical trial using a proprietary fractionated white bean extract. Alternative Therapies 2007;13(4):32-37.
  • Udani JK, Singh BB, Barrett ML, Preuss HG. Lowering the glycemic index of white bread using a white bean extract. Nutrition Journal 2009;8:52.
  • USDA 2010: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Next link will take you to another Web site Germplasm Resources Information Network (GRIN). [Internet].National Germplasm Resources Laboratory, Beltsville (MD). [Phaseolus vulgaris. Last updated 2010 August 19; Accessed 2013 April 17].
  • Vinson JA, Kharrat HA, Shuta D. Investigation of an amylase inhibitor on human glucose absorption after starch consumption. The Open Nutraceuticals Journal 2009;2:88-91.
  • Wu X, Xu X, Shen J, Perricone N, Preuss H. Enhanced weight loss from a dietary supplement containing standardized Phaseolus vulgaris extract in overweight men and women. Journal of Applied Research 2010;10:73-79.

References reviewed