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.

Object: Fucoidan is a sulfated polysaccharide in brown marine algae. Gagome kombu (Kjellmaniella crassifolia) is a Japanese edible seaweed and contains fucoidan abundantly. Recently, it was reported that fucoidan from Gagome kombu (GKF) had anti-tumor, immune-enhancing and anti-coagulant activities. In this study, we conducted a safety of GFK on the healthy adult.
Methods: Thirty-two healthy volunteers were randomly divided into 4 groups and administered a standard volume and three times volume of two kinds of test drinks containing GKF for 4 weeks.
Result: No abnormal changes were observed after test drinks ingestion on blood chemistry, urinalysis, hematological data and blood pressure. No severe adverse events related to test drinks were observed. Moreover, increase of Th1 cells was observed in immunological analysis.
Conclusion: This study suggests that GKF is safe in healthy adults.

Coix lacryma-jobi L. var.ma-yuen Stapf (Coix seed) is a grass crop that has long been used in traditional medicine as a nourishing food. However, high-intake safety of the extract of the husks, pellicles and astringent skin of Coix seed has rarely been evaluated. We performed a safety test of hot water extract of all parts of Coix seed (CRD extract) in rats. CRD extract showed no significant toxicity on body weight, blood analyses, urinalysis and histopathological examination in acute toxicity tests.

We conducted a preliminary study of the facial skin-improving effects of collagen-containing beverages as evaluated by objective indices. After obtaining written informed consent, 61 healthy females (age: 25–68, 34±8 y.o.) were randomly divided into two groups, receiving beverages containing 5 g (N=30) and 10 g (N=31), respectively, of collagen daily for one month. Facial skin moisture content and lower eyelid wrinkles were assessed before, 1 week and 1 month after consuming the test beverages. Results were analyzed of the 5 g and 10 g groups, as well as responder and non-responder groups. 10 g collagen beverages showed 50% effectiveness, and were more effective than the 5 g beverage; the effect was observable within 1 week. Furthermore, subjects with more wrinkles and drier skin showed greater benefit than those with higher facial skin moisture content and/or fewer wrinkles. It is suggested that a beverage containing 10 g collagen should be used for aged subjects with more wrinkles and/or drier skin for a period of 1–2 months in future randomized placebo-controlled trials of collagen-containing beverages.

Fresh kiwi fruit freeze-dried juice has been traditionally used for constipation of elderly patients. Its effectiveness and safety was studied in 42 elderly patients (age 60–84: median age 67±6) suffering from mild to moderate constipation, taken as a food supplement of 6 capsules/3 times per day for 4 weeks following a one week control period, after receiving written informed consent. Bowel habits and generic quality of life questionnaires were monitored. Bowel habits such as evacuation time and stool quality improved from the 14^th day and continued for 28 days compared to the control period.
Quality of life in terms of external appearance (such as skin and edema), lumbago, and headache improved. In conclusion, freeze-dried fresh kiwi fruit juice had a laxative and QOL-improving effect on the elderly. No apparent adverse effects were observed.

Coix lacryma-jobi L. var.ma-yuen Stapf (coix seed) is a grass crop that has long been used in traditional medicine as a nourishing food. However, high-intake safety of the extract of the husks, pellicles and astringent skin of coix seed has rarely been evaluated. We performed a 28-day repeated dose oral toxicity test of hot water extract of all parts of Coix seed in rats. The extract showed no significant toxicity on body weight, blood analyses, urinalysis and histopathological examination in acute toxicity tests.

Coix lacryma-jobi L. var. ma-yuen Stapf is a grass long been used in traditional medicine as a nourishing food and reported to possess pharmacological effects including anti-tumor, anti-obesity, anti-diabetic, etc. In order to evaluate the possible mutagenicity of the hot water extract of all parts (husks, pellicles, and astringent skin) of the food, we performed a reverse mutation test in bacteria, a mouse lymphoma assay and a mouse micronucleus test. The results of all tests were negative. It was concluded that the extract has no mutagenicity for living bodies.

Of “foods for specified health use (FOSHU)”, approximately 90 kinds are presently indicated as “appropriate for hypertension”. In this review we describe their safety and effectiveness.

An exploratory open-label human clinical study was performed in healthy adults with shoulder stiffness to evaluate the efficacy of Astaxanthin by means of measuring blood flow change in the shoulders and subjective questionnaires on physical conditions, including alleviation of stiffness before and after treatment. Two capsules containing 3 mg Astaxanthin each (6 mg in total) were administered once daily (6 mg a day) on days 1 to 28 (4 weeks) to 13 patients (3 men/10 women). All patients were assessed for efficacy and the study demonstrated significant improvements in physical conditions such as shoulder stiffness, physical fatigue, sense of mental irritation, sense of coldness in hands and feet, eye fatigue and eye bleariness. Significant increases of blood flow in shoulders were observed at the end of treatment using laser-doppler graphics. Blood tests conducted to confirm safety before and at the end of treatment showed no clinical differences, and no adverse side effects were reported. In conclusion, Astaxanthin appeared to safely alleviate stiff shoulders and improve other physical conditions during a 4-week open-label study.

Approximately 100 kinds of Foods for Specified Health Use (FOSHU) are used to “control postprandial elevated blood glucose level”. In this review, we describe their safety and effectiveness.