60 cancer patients between the ages of 20 and 80 who had completed a main treatment were randomly administered Tabebuia Avellanedae (Taheebo) extract 2.0 g/day (usual dosage), 4.0 g/day (2 times dosage), or 6.0 g/day (3 times dosage) for 6 months. A blood biochemical exam, urinalysis, adverse effects, several immunological parameters, urine 8-OHdG and QOLsurvey were evaluated. Five patients dropped out, but there was no direct cause and effect between the extract and dropout. Although several items of the blood biochemical exam revealed slight variation within the normal limits, distinct abnormities were not detected. Furthermore, side effects like allergic symptoms were not found. Immune parameters and urine 8-OHdG did not change significantly. CRP, which is a sensitive marker of inflammation, was significantly improved, and this may suggest the possibility of this extract helping to prevent hardening of blood vessels due to arteriosclerosis. In Japan, long-term food safety tests have rarely been done, therefore we recommend that more of these exams be carried out.

We evaluated the safety of fucoidan from Gagome Kombu (GKF) in genotoxicity tests. In bacterial reverse mutation test, GKF had no reverse mutation inducing activity on five bacterial strains with or without S9 metabolic activation. In chromosome aberration test, GKF had neither structural nor numerical chromosome aberration inducibility with or without S9 metabolic activation. In micronucleus test, neither formation of micronuclei nor decrease of mironucleated reticulocytes was observed in the bone marrow of the mice treated by GKF. These results indicate that GKF has no genotoxic activities under the condition of this study.

Object: Gagome kombu (Kjellmaniella cracciforia) is the edible brown seaweed and contains fucoidan, a sulfated polysaccharide, abundantly. Bunashimeji (Hypsizigus marmoreus) is the popular Japanese mushrooms and contains polyterpenes as the bitter substance. Previously, we investigated the bioactive functions (e.g. anti-tumor action) and the safety of fucoidan from Gagome kombu (GKF) and the extract from Bunashimeji (KTE: Kinoko terpene extract). In this study, we evaluate the influence of GKF and KTE on hepatic cytochrome P450 (CYP).
Methods: Male SD rats were divided into three groups (n = 5). 2,000 mg/kg of GKF and KTE were given orally once daily for 4 days.
Result: There were no difference in activities and mRNA expressions of hepatic CYPs (CYP2C11, CYP2D, CYP2E1 and CYP3A1) among all groups.
Conclusion: These results indicated GKF and KTE did not influence the rat hepatic CYPs.