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Clinical Trial at Kitasato Institute, Japan
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Summary

Excessive oxidation reaction in living bodies induces sedimentation of blood cells such as erythrocytes and leukocytes on the intima of the blood vessels, contribution to occurrence of arteriosclerosis. The major causes are attributed to activation of vascular endothelial cells and stimulation of platelet agglutination due to lipid peroxides. These are usually caused by excessive intake of lipid, influences of intestinal environment or stresses. The following clinical study was conducted with healthy volunteers using “preB food,” which is classified as a fermented vegetable food, and is recognized to affect the intestinal bacterial flora, which is conducive to controlling the intestinal environment. PreB is a kind of supplemental health food containing over 55 kinds of grains, vegetables, fruits and wild herbs. Hematological and biochemical tests centering on hepatic function assessment were performed before and after the ingestion of the test substance.

Together with molecular biological analyses of the intestinal bacterial flora, and immunological analyses mainly on T cells, the presence or absence of the possible influences of preB on the body was investigated.

The results confirmed that the ingestion of preB does not provide any influences on either hepatic functions or changes in lipid metabolisms. In addition, it indicated that in more than half the volunteer subjects there was a change in the intestinal environment. It suggested that preB would not cause any safety-related problems, and at the same time exhibit positive effects on the intestinal environment.

Introduction

Oxidated substances produced by aging and stresses in the body are involved in the excessive accumulation of hyper-oxidated lipids, hepatic disorders and arteriosclerosis. They also possess the risk of inducing carcinogenicity through DNA damage in the cells. Oxidated substances in the body exist as metabolites, which are derived from the biological defense mechanisms. In addition, however, they accumulate excessively in the body due to westernized dietary habits or stresses, and currently attention has been paid to them as one of the causes of the stimulation of aging along with the above-stated diseases. In this connection, excessive ingestion of lipids is responsible for the onset of lifestyle-related diseases including arteriosclerosis and hypertension as their direct causes whereas the intestinal environment is also designated as one of the indirect factors to incur these diseases. For the purpose of improving the intestinal environments, probiotic products, mainly comprising lactic acid bacteria beverages, have currently been employed. In this relation, development of functional foods exerting normalization of the intestinal environment and anti-oxidation effects against oxidants is highly expected in terms of their usefulness as the QOL improving supplements.

PreB used in the present study is designated as a liquid-type health food containing vegetable-origin lactobacillus and dietary fiber. PreB also contains other useful ingredients such as Lutein, which is a yellow pigment contained in green and yellow vegetables and is known to exert anti-oxidation effects, plus it represents carotenoids (pigment group) like ß -carotene and lycopene. In the present study, efficacy confirmation and the safety verifications were conducted using preB in healthy volunteers as the study subjects.

TitleSafety study on preB
Study Number00802
Purpose:To re-confirm the safety of preB by assessing the hepatic function test items, and also to analyze the possible influences on the intestinal environment.
Sponsor
Name:Naturally Yours Co., Ltd.
Address:Takanawa Chuo Building 6F, 2-20-23, Takanawa, Minato-ku, Tokyo
Tel: 03-5791-3308, Fax: 03-3446-4708
Responsible person:Ohno Taichi
Assignee
Name:Research Center for Medical Environment,
Division of Biomedical Research,
Kitasato Institute Medical Center Hospital
Kitasato University,
The Kitasato Institute
Address:5-9-1, Shirogane, Minato-ku, Tokyo
Director of the Center:Ph.D. Suzuki Tatsuo
Name:Biomedical Laboratory &RCME, Division of Biomedical Research, Clinical Trial Section, Division of Clinical Research, Kitasato Institute Medical Center Hospital, Kitasato University,
The Kitasato Institute
Chief Administrator:Ph.D. Kobayashi Noritada
Investigators:Ph.D. Kobayashi Noritada
Shimamura Shizue
Ph.D. Yamazaki Taiga
Iwakata Jun
Chief Investigator:MD & Ph.D. Hirose Ryuichi
Study Director:Suzuki Tatsuo

Date of study initiation:May 14, 2008
Date of study completion:September 9, 2008
Date of preparation of the final report:September 17, 2008