Safety studies regarding a standardized extract of fermented wheat germ.
"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.
Heimbach
James T
JT
JHeimbach LLC, Port Royal, Virginia 22535, USA. jh@jheimback.com
Sebestyen
Gyula
G
Semjen
Gabor
G
Kennepohl
Elke
E
D000818:Animals; D016588:Anticarcinogenic Agents / Q000592:standards / Q000627:therapeutic use / Q000633:toxicity; D016227:Benzoquinones / Q000032:analysis / Q000592:standards; D016466:CHO Cells; D002986:Clinical Trials as Topic; D003257:Consumer Product Safety; D006224:Cricetinae; D003412:Cricetulus; D053938:DNA Fragmentation / Q000187:drug effects; D019587:Dietary Supplements / Q000592:standards / Q000633:toxicity; D005260:Female; D007928:Lethal Dose 50; D008297:Male; D051379:Mice; D008815:Mice, Inbred Strains; D009369:Neoplasms / Q000517:prevention & control; D019055:No-Observed-Adverse-Effect Level; D010936:Plant Extracts / Q000592:standards / Q000627:therapeutic use / Q000633:toxicity; D051381:Rats; D011916:Rats, Inbred F344; D017208:Rats, Wistar; D018675:Toxicity Tests / Q000379:methods*; D014908:Triticum / Q000737:chemistry*
D016588:Anticarcinogenic Agents; C113915:Avemar; D016227:Benzoquinones; D010936:Plant Extracts; C030511:2,6-dimethoxy-1,4-benzoquinone