Unique ID issued by UMIN | UMIN000018529 |
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Receipt number | R000021420 |
Scientific Title | Safety evaluation studies of long-term consumption of food containing resistant glucan (water-soluble dietary fiber) in healthy subjects or subjects with pre- constipation subjects |
Date of disclosure of the study information | 2015/08/07 |
Last modified on | 2016/05/20 09:27:13 |
Safety evaluation studies of long-term consumption of food containing resistant glucan (water-soluble dietary fiber) in healthy subjects or subjects with pre- constipation subjects
Safety evaluation studies of long-term consumption of food containing resistant glucan (water-soluble dietary fiber) in healthy subjects or subjects with pre- constipation subjects
Safety evaluation studies of long-term consumption of food containing resistant glucan (water-soluble dietary fiber) in healthy subjects or subjects with pre- constipation subjects
Safety evaluation studies of long-term consumption of food containing resistant glucan (water-soluble dietary fiber) in healthy subjects or subjects with pre- constipation subjects
Japan |
Healthy adult
Adult |
Others
NO
To evaluate the safety of long-term consumption of food containing resistant glucan (water-soluble dietary fiber), quantity of recommended daily intake.
Safety
Adverse event
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Food |
Ingestion of the test product for 12 weeks
20 | years-old | <= |
64 | years-old | >= |
Male and Female
(1) Healthy adult males and females from 20 to 64 years of age
(2) Subjects falling under any of the following
A. 10 subjects whose normal stool frequency is around 3-5 times per week
B. 10 subjects whose normal stool frequency is around 7 times per week
(1) Subjects visiting the hospital for diseases related bowel movements and using drugs, or using commercial laxative
(2) Subjects currently undergoing treatment with digestive diseases that affect the study or having a surgical history of digestive system (except appendicectomy)
(3) Subjects having diseases (irritable enteritis, ulcerative colitis, etc.) affecting bowel movement or a history of these diseases
(4) Subjects having a disease requiring treatment or a history of serious diseases, diabetes, hepatopathy, renal or heart disease
(5) Subjects having possibilities for emerging allergy related to the study
(6) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required
(7) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(8) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
(9) Subjects who intend to become pregnant or lactating
(10) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(11) Subjects judged as unsuitable for the study by the investigator for other reasons
20
1st name | |
Middle name | |
Last name | Toshihiro Yamamoto |
NIHON SHOKUHIN KAKO CO., LTD.
RESEARCH INSTITUTE
30 TAJIMA FUJI, SHIZUOKA
0545-53-5995
toshihiro.yamamoto@nisshoku.co.jp
1st name | |
Middle name | |
Last name | Yuki Kitahara |
TTC Co.,Ltd.
Clinical Research Planning Department
Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
03-5459-5329
y.kitahara@ttc-tokyo.co.jp
TTC Co.,Ltd.
NIHON SHOKUHIN KAKO CO., LTD.
Profit organization
NO
2015 | Year | 08 | Month | 07 | Day |
Unpublished
Completed
2015 | Year | 07 | Month | 23 | Day |
2015 | Year | 08 | Month | 08 | Day |
2015 | Year | 08 | Month | 03 | Day |
2016 | Year | 05 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021420
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