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Toxicity Studies of Blockal, a Dietary Supplement Containing Phase 2 Starch Neutralizer (Phase 2), a Standardized Extract of the Common White Kidney Bean (Phaseolus vulgaris)

Pharmachem Laboratories, Inc., Kearny, New Jersey, USA

Correspondence: Address correspondence to Dilip Chokshi, MSc, MS, Director, New Products, Pharmachem Laboratories, Inc., 265 Harrison Avenue, Kearny, NJ 07032, USA. E-mail:dchokshi{at}pharmachem.com

The number of available dietary supplements containing "starch blockers" intended for weight loss has risen dramatically in recent years. These supplements are believed to reduce carbohydrate-derived calories by interfering with -amylase, the digestive enzyme responsible for conversion of complex carbohydrates to simple absorbable sugars. The present paper reports the findings of single- and multiple-dose (4-week) oral toxicity studies in rats of the marketed dietary supplement Blockal. Blockal contains as its main ingredient Phase 2 Starch Neutralizer (Phase 2 or Phaseolamin 2250), a standardized extract derived from the common white kidney bean (Phaseolus vulgaris) that has been shown to have -amylase-inhibiting activity. The Blockal acute oral LD₅₀ exceeded the highest dose tested (3 g/kg body weight [bw]), which provided a single dose of 1668 mg/kg bw of Phase 2 white kidney bean extract. The no-observed-effect level (NOEL) seen in the 4-week study was equivalent to the highest Blockal dose tested (2 g/kg bw/day), which provided 1112 mg/kg/day of Phase 2 white kidney bean extract. The results of these studies support and are consistent with the safety of the marketed dietary supplement Blockal, and indirectly, the safety of its main ingredient, Phase 2 Starch Neutralizer (Phase 2 or Phaseolamin 2250), a standardized extract derived from the common white kidney bean.

Key Words: -Amylase Inhibitor • Phase 2 • Phaseolus vulgaris • Safety • Starch Blocker • Toxicity

International Journal of Toxicology, Vol. 25, No. 5, 361-371 (2006)
DOI: 10.1080/10915810600846229


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