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International Journal of Toxicology
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Article

Safety Studies Regarding a Standardized Extract of Fermented Wheat Germ

James T. Heimbach

JHeimbach LLC, Port Royal, Virginia, USA

Gyula Sebestyen

Department of Public Health, Faculty of Medicine, Semmelweis University, Budapest, Hungary

Gabor Semjen

Department of Pharmacology and Toxicology, Faculty of Veterinary Science, Szent Istvan University, Budapest, Hungary

Elke Kennepohl

Write-Tox Consulting, Spruce Grove, Alberta, Canada

Correspondence: Address correspondence to James T. Heimbach, PhD, FACN, JHeimbach LLC, 923 Water Street, P.O. Box 66, Port Royal, VA 22535, USA. E-mail:jh{at}jheimbach.com

"Avemar pulvis" is a powder consisting of an aqueous extract of fermented wheat germ, with the drying aids maltodextrin and silicon dioxide, standardized to contain approximately 200 µg/g of the natural constituent 2,6-dimethoxy-p-benzoquinone. The results of toxicological and clinical studies of this product demonstrate its safety for its intended use as a dietary supplement ingredient in the United States. Avemar pulvis has been used in Hungary since 1998 and is approved in that country, as well as in the Czech Republic, Bulgaria, and Romania, as a "medical nutriment for cancer patients." Acute and subacute toxicity studies using rodents orally administered Avemar pulvis showed that dose levels (2000 to 3000 mg/kg body weight [bw]/day) exceeding the normal recommended oral dosage (8.5 g/day or 121 mg/kg bw/day for a 70-kg individual) by up to approximately 25-fold caused no adverse effects. The test substance showed no evidence of mutagenicity or genotoxicity in vitro or in vivo. Clinical studies using Avemar pulvis as a supplement to drug therapy in cancer patients at doses of 8.5 g/day not only showed no evidence of toxicity, but also showed a reduction in the side effects of chemotherapy. Overall, it was concluded that Avemar pulvis would not be expected to cause adverse effects under the conditions of its intended use as an ingredient in dietary supplements.

Key Words: Avemar pulvis • Dietary Supplement • DMBQ • Fermented Wheat Germ • Safety • Toxicity

International Journal of Toxicology, Vol. 26, No. 3, 253-259 (2007)
DOI: 10.1080/10915810701369709
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