Safety studies regarding a standardized extract of fermented wheat germ

Area of Science:

• Nutritional Science
• Toxicology
• Pharmacology

Background:

• Avemar pulvis is a dietary supplement derived from fermented wheat germ.
• It is approved as a medical nutriment for cancer patients in several European countries.
• The active compound is 2,6-dimethoxy-p-benzoquinone.

Purpose of the Study:

• To evaluate the safety and potential benefits of Avemar pulvis.
• To assess toxicological and clinical effects for its use as a dietary supplement ingredient.

Main Methods:

• Acute and subacute toxicity studies in rodents.
• In vitro and in vivo mutagenicity and genotoxicity assays.
• Clinical studies in cancer patients receiving Avemar pulvis as a supplement to drug therapy.

Main Results:

• Oral administration in rodents at doses up to 25-fold the recommended human dose showed no adverse effects.
• No evidence of mutagenicity or genotoxicity was observed.
• Clinical studies demonstrated no toxicity and a reduction in chemotherapy-related side effects.

Conclusions:

• Avemar pulvis is safe for its intended use as a dietary supplement ingredient.
• The product may help mitigate side effects associated with cancer drug therapy.
• Further research may explore its therapeutic potential in oncology support.