Unique ID issued by UMIN | UMIN000021511 |
---|---|
Receipt number | R000024803 |
Scientific Title | Safety evaluation of excessive intake of newly developed functional food containing lactic acid bacteria powder in healthy adults |
Date of disclosure of the study information | 2016/03/17 |
Last modified on | 2017/01/25 17:34:54 |
Safety evaluation of excessive intake of newly developed functional food containing lactic acid bacteria powder in healthy adults
Safety evaluation of excessive intake of functional food containing lactic acid bacteria powder
Safety evaluation of excessive intake of newly developed functional food containing lactic acid bacteria powder in healthy adults
Safety evaluation of excessive intake of functional food containing lactic acid bacteria powder
Japan |
Healthy adults with or without a tendency for constipation
Adult |
Others
NO
In order to investigate the safety of excessive consumption of food containing lactic acid bacteria powder for 4 weeks
Safety
The incidence of side effects during intervention
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Intervention
Test tablets (containing lactic acid bacteria powder)
Duration: 4 weeks
Amount: 4.4 g daily
Control
Placebo tablets
Duration: 4 weeks
Amount: 4.4 g daily
20 | years-old | <= |
70 | years-old | > |
Male and Female
(1) Japanese untreated males and females from 20 to 69 years of age.
(2) Those judged as suitable for the study by the principal investigator.
(3) Those who gave the written informed consent before the study.
(1) A medical history of severe disorders, or continuous medical treatment.
(2) A surgical history of digestive system (except appendicectomy)
(3) Constantly usage of medical agents for constipation, supplements and/or functional foods (including Food for Specified Health Uses [FOSHU]) for intestinal regulation.
(4) With allergy to lactic acid bacteria, milk, soybean, or citrus/
(5) Those who are pregnant or have possibility to become pregnant during the study or breast-feeding.
(6) Those who drink alcohol a lot or heavy smoker.
(7) Those having an extremely irregular diet habit (unexpectedly skipping three or more meals a week)
(8) Alternative work schedule, or work on midnight shift.
(9) Those who are participating or plan to participate the other clinical tests (foods, medicines, cosmetics or liniments) during the study.
(10) Those judged as unsuitable for the study by the principal investigator for other reasons.
44
1st name | |
Middle name | |
Last name | Kazuhiko Takano |
Medical Corporation Hokubukai
Utsukushigaoka Hospital
61-1 Sin-ei, Kiyota-ku, Sapporo, Hokkaido 004-0839, Japan
011-882-0111
info@csc-smo.co.jp
1st name | |
Middle name | |
Last name | Isao Takehara |
Clinical Support Corporation
PI-Food Service Division
4-1 South 1 West 8, Chuo-ku, Sapporo, Hokkaido 060-0061, Japan
011-223-3130
takehara@csc-smo.co.jp
Clinical Support Corporation
Asahi Group Holdings, Ltd.
Profit organization
NO
2016 | Year | 03 | Month | 17 | Day |
Unpublished
Completed
2016 | Year | 02 | Month | 25 | Day |
2016 | Year | 03 | Month | 17 | Day |
2016 | Year | 03 | Month | 17 | Day |
2017 | Year | 01 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024803
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |