The Safety and Immune-efficacy of Fucoidan from Gagome Kombu (Kjellmaniella crassifolia) on Women with the History of Gynecological Cancer / 日本補完代替医療学会誌

Objective: Fucoidan is a sulfated polysaccharide in brown seaweeds. Previous studies show that fucoidan from Gagome kombu (GKF) exhibit immune-enhancing capabilities on healthy adults. In this study, we focused on the women with the history of gynecological cancer and evaluated the safety and immune-efficacy of GKF.Methods: Ten Japanese women subjects were chosen to ingest the test samples (1 drink / day containing 200 mg GKF) for 4 weeks. Before and after ingestion, blood chemistry analysis, hematological analysis, urinalysis and immune analysis were conducted. Result: Results showed no adverse clinical changes in blood and urinary analysis. In addition, no serious symptoms were observed. Moreover, decrease of serum levels of Eotaxin, IL-7, IL-17 and VEGF were observed.Conclusion: These results indicate that in the case of women with the history of gynecological cancer, GKF is a safe functional food ingredient.

Immune Efficacy and Safety of Fucoidan Extracted from Gagome Kombu <i>(Kjellmaniella crassifolia)</i> in Healthy Japanese Subjects / 日本補完代替医療学会誌

Objective: We previously reported the immune-enhancing behavior of fucoidan, a sulfated polysaccharide extracted from Gagome kombu (GKF), both in vitro and in animal studies. In the present study, we evaluated the immune efficacy and safety of GKF in healthy Japanese adults.Methods: In this randomized, double blind, placebo-controlled study, 30 subjects who ingested GKF (200 mg/day) or placebo for 4 weeks were enrolled. For evaluation of efficacy, phytohemagglutinin-stimulated cytokine production in whole blood cells was measured. For evaluation of safety, blood chemistry analysis, hematological analysis, and urinalysis were conducted.Results: Almost all cytokine production decreased in samples from the placebo group during the test period. Ingestion of GKF for 4 weeks significantly suppressed the decrease in production of the T helper 1 (Th1)-type cytokines interferon-γ and interleukin-12 as well as the Th1:Th2 ratio. There were no adverse clinical changes in blood analysis and urinary analysis, and no serious symptom was observed.Conclusion: These results indicate that GKF is a useful and safe food ingredient to support immune function.

The Safety of Long-Term Ingestion of Fucoidan from Gagome Kombu (<i>Kjellmaniella Crassifolia</i>) on Cancer Patients / 日本補完代替医療学会誌

<b>Objective:</b> Fucoidan, a sulfated polysaccharide in Gagome kombu (GKF) is known to exhibit immune-enhancing and anti-cancer activities. Recently, cancer patients use various dietary supplements containing fucoidan and mushroom extracts. However, there have been few reports on the safety and efficacy of fucoidan-containing supplements. In this study, we examined the safety of long-term ingestion of GKF in cancer patients.<br> <b>Methods:</b> Twenty six (26) Japanese cancer patients—16 of whom (male 6, female 10, age 62.8 ± 10.7) have completed cancer treatment and 10 (male 4, female 6, 67.0 ± 10.6) still under treatment and regularly taking anti-cancer drugs and hormone pills—were chosen to ingest GKF-containing supplements (200–300 mg/day) for 8 weeks. Before ingestion and every 4 weeks thereafter (4^th and 8^th week), blood chemistry analysis, hematological analysis, urinalysis and immune analysis were conducted.<br> <b>Result:</b> There were no adverse clinical changes in blood and urinary analysis. In addition, no serious adverse effects were observed.<br> <b>Conclusion:</b> These results indicate long-term ingestion of GKF is indeed, safe for cancer patients.<br>

Safety of Excessive Intake of <i>Ashitaba</i> Green Juice in Normal and Borderline Mildly Diabetic Subjects / 日本補完代替医療学会誌

<b>Objective</b>: “<i>Ashitaba</i>” (<i>Angelica keiskei</i>) is a traditional vegetable peculiar to Japan. <i>Ashitaba</i> contains vitamins, dietary fiber and polyphenols such as chalcones abundantly. We previously reported anti-diabetic action of <i>Ashitaba </i>in an animal model as well as in diabetics. In this study, we evaluated the safety of<i> Ashitaba</i> green juice in healthy and borderline mildly diabetic subjects.<br> <b>Methods</b>: Japanese adult subjects (n = 24) ingested <i>Ashitaba</i> green juice (31.5 g granulated powder) for 4 weeks. For evaluation of safety, blood chemistry analysis, hematological analysis and urinalysis were conducted.<br> <b>Result</b>: On excessive ingestion of <i>Ashitaba</i> green juice for 4 weeks, there were no adverse clinical changes in blood analysis and urinary analysis and no serious symptom was observed.<br> <b>Conclusion</b>: These results indicate that excessive ingestion of <i>Ashitaba</i> green juice is safe in healthy and borderline mildly diabetic subjects.<br>

Safety Evaluation of <i>Ashitaba</i> (<i>Angelica Keiskei</i>) on Mutagenic Test, Single and 13-Weeks Oral Toxicity Tests / 日本補完代替医療学会誌

We evaluated the safety of <i>Ashitaba</i> (<i>Angelica keiskei</i>) in bacterial reverse mutation test as well as single and 13-weeks oral toxicity tests. In the bacterial reverse mutation test, ethanol extract of <i>Ashitaba</i> had no reverse mutation inducing activity on five bacterial strains with or without S9 metabolic activation. In the single oral toxicity test, <i>Ashitaba</i> powder (3,500 mg/kg/day) showed no adverse effects in male and female SD rats. In the 13-week repeated oral toxicity test, <i>Ashitaba</i> powder (875 and 1,750 mg/kg/day) showed no adverse effects on body weight, food consumption, blood biochemistry, hematology, urinalysis, ophthalmoscopy, organ weight and histopathology in male and female SD rats. These results indicate that<i> Ashitaba</i> is very safe foodstuff under the conditions of this study.<br>

The Safety and Immune-Efficacy of Fucoidan from Gagome Kombu (<i>Kjellmaniella crassifolia</i>) on the Elderly / 日本補完代替医療学会誌

<b>Objective:</b> Gagome kombu (<i>Kjellmaniella crassifolia</i>), an edible brown seaweed grown around the southern area of Hokkaido, is known to abundantly contain fucoidan. Previous studies show that on animals, fucoidan from Gagome kombu (GKF) exhibits immune-enhancing, anti-cancer and anti-influenza virus capabilities. In this study, we focused on the elderly and evaluated the safety and immune-efficacy of GKF.<br> <b>Methods:</b> Eighteen (18) Japanese elderly subjects were chosen to ingest the test samples (3 tablets/day containing 50 mg GKF and lactic acid bacteria) for 8 weeks. Before ingestion and every 4 weeks thereafter (4^th and 8^th week), blood chemistry analysis, hematological analysis, urinalysis and immune analysis were conducted.<br> <b>Result:</b> Test results showed no adverse clinical changes in blood and urinary analysis. In addition, no serious symptoms were observed. Moreover, GKF markedly decreased serum IgE levels.<br> <b>Conclusion:</b> These results indicate that in the case of elderly, GKF is a safe functional food ingredient.<br>

Efficacy and Safety of<i> Ashitaba</i> (<i>Angelica keiskei</i>) on the Patients and Candidates with Metabolic Syndrome: A Pilot Study / 日本補完代替医療学会誌

<b>Objective</b>: “<i>Ashitaba</i>” (<i>Angelica keiskei</i>) is a traditional vegetable unique to Japan. <i>Ashitaba</i> contains an abundance of vitamins, dietary fiber and polyphenols such as chalcones. We previously reported anti-diabetic behavior of chalcones from <i>Ashitaba</i>. In this study, we evaluated the efficacy and safety of<i> Ashitaba</i> on patients and candidates with MetS.<br> <b>Methods</b>: Nine adult subjects defined as patients and candidates with MetS ingested <i>Ashitaba</i> green juice (6.2 g/day of granulated powder containing 12.3 mg chalcones) for 8 weeks. For evaluation of efficacy, abdominal fat area, body weight, body fat and blood parameters were measured. For evaluation of safety, blood chemistry analysis, hematological analysis and urinalysis were conducted.<br> <b>Result</b>: Ingestion of <i>Ashitaba</i> green juice for 8 weeks significantly decreased visceral fat area, body weight, BMI and body fat, respectively. There were no adverse clinical changes in blood analysis and urinary analysis, and no serious symptom was observed.<br> <b>Conclusion</b>: These results indicate that it is possible that <i>Ashitaba</i> is a useful and safe foodstuff for the prevention of MetS.<br>

Safety Evaluation of Fucoidan from <i>Kjellmaniella Crassiforia</i> and Extract from <i>Hypsizigus Marmoreus</i>: Influence on the Activities and Gene Expressions of Rat Hepatic CYPs / 日本補完代替医療学会誌

<b>Object:</b> Gagome kombu (<i>Kjellmaniella cracciforia</i>) is the edible brown seaweed and contains fucoidan, a sulfated polysaccharide, abundantly. Bunashimeji (<i>Hypsizigus marmoreus</i>) 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).<br> <b>Methods:</b> 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.<br> <b>Result:</b> There were no difference in activities and mRNA expressions of hepatic CYPs (CYP2C11, CYP2D, CYP2E1 and CYP3A1) among all groups.<br> <b>Conclusion:</b> These results indicated GKF and KTE did not influence the rat hepatic CYPs.<br>

Safety Evaluation of Fucoidan from Kjellmaniella Crassifolia in Genotoxicity Tests / 日本補完代替医療学会誌

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.<br>

Safety of fucoidan from Gagome kombu (Kjellmaniella crassifolia) in healthy adult volunteers / 日本補完代替医療学会誌

<b>Object:</b> Fucoidan is a sulfated polysaccharide in brown marine algae. Gagome kombu (<i>Kjellmaniella crassifolia</i>) 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.<br> <b>Methods:</b> 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.<br> <b>Result:</b> 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.<br> <b>Conclusion:</b> This study suggests that GKF is safe in healthy adults.<br>