Safety Studies Regarding a Standardized Extract of Fermented Wheat Germ

Abstract

"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 microg/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.

Avemar, a nontoxic fermented wheat germ extract, attenuates the growth of sensitive and 5-FdUrd/Ara-C cross-resistant H9 human lymphoma cells through induction of apoptosis

“…However, the percentage of apoptotic cells reached a maximum of 48% at a concentration of 300 μg/ml since higher dosage of the drug (600 μg/ml) was not able to significantly intensify the observed effect. This might be the reason for the fact that Avemar demonstrated no signs of toxicity in various studies (25), whereas more potent anticancer drugs exert a number of dose-limiting toxic side effects when applied to humans.…”

Avemar (Wheat Germ Extract) in Cancer Prevention and Treatment

“…The effects of Avemar are manifold (3)(4)(5)(6)(7). On the contrary, it shows no toxicity, mutagenicity, or genotoxicity (8). Moreover, the combination of Avemar with chemotherapeutic agents did not increase the toxicity or reduce antiproliferative activity (9).…”

Safety Study of Yeast Hydrolysate with below 10 kDa Molecular Weight in Animal Models

“…Its subacute toxicity is also very low, as no toxicity was observed at the highest dose tested in rats, 1868 mg/kg. 17) Kim et al 11) tried to assess the anti-obesity effect of yeast hydrolysate with below 10 kDa molecular weight and found that it reduced body weight in SD rats fed a high fat diet. To investigate the effects of yeast hydrolysate with below 10 kDa molecular weight on appetite regulation mechanisms in Values are means ± S.D.…”