Unique ID issued by UMIN | UMIN000034833 |
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Receipt number | R000039726 |
Scientific Title | Exploratory test on the influence of Frugra(R) intake for two weeks on changes in intestinal environment and amount of salt intake |
Date of disclosure of the study information | 2018/11/09 |
Last modified on | 2020/06/10 13:39:59 |
Exploratory test on the influence of Frugra(R) intake for two weeks on changes in intestinal environment and amount of salt intake
Exploratory test on the influence of Frugra(R) intake on changes in intestinal environment and amount of salt intake
Exploratory test on the influence of Frugra(R) intake for two weeks on changes in intestinal environment and amount of salt intake
Exploratory test on the influence of Frugra(R) intake on changes in intestinal environment and amount of salt intake
Japan |
Healthy Adults
Not applicable |
Others
NO
Explore the influence of replacement of breakfast with Frugra(R) meal for two weeks on changes in intestinal environment and amount of salt intake before and after ingestion.
Efficacy
Urinary indoxyl sulfate at the beginning of the test or after Frugra(R) ingestion for 2 weeks
Estimated amount of salt intake by spot urine at the beginning of the test or after Frugra(R) ingestion for 2 weeks
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Replace breakfast with about 50 g of Frugra(R) (Calbee, Inc.) per meal with or without milk or soy milk for two weeks
20 | years-old | <= |
Not applicable |
Male and Female
1.Persons who have had urinary indoxyl sulfate test (trade name: intestinal environmental test "chokatsu check") in Healthcare Systems Co., Ltd. in the past
2.Healthy Japanese who are 20 years old
3.Choose persons whose latest urinary indoxyl sulfate value are higher from the top
1.Persons who are allergic to the test food
2.Persons who regularly use medicines and quasi-drugs that may affect intestinal environment such as antibiotics
3.Persons who intend to take new supplements during the exam
4.Persons who are breastfeeding, pregnant, scheduled or hoping to be pregnant during the exam period
5.Persons who participated in other examination during the first month before the start of the exam, or those who plan to participate in other exams following this exam agreement
6.Persons who are judged inappropriate for the exam by the principal investigator
30
1st name | Takanori |
Middle name | |
Last name | Yasutake |
Healthcare Systems Co., Ltd.
Marketing and Sales Promotion Division
1050004
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
03-6809-2722
yasutake@hc-sys.jp
1st name | Takanori |
Middle name | |
Last name | Yasutake |
Healthcare Systems Co., Ltd.
Marketing and Sales Promotion Division
1050004
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
03-6809-2722
yasutake@hc-sys.jp
Healthcare Systems Co., Ltd.
Calbee, Inc.
Profit organization
The Ethics Committee of Healthcare Systems Co., Ltd.
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
03-6809-2722
soumu@hc-sys.jp
NO
2018 | Year | 11 | Month | 09 | Day |
https://www.calbee.co.jp/rd/result/report38.php
Partially published
https://www.calbee.co.jp/rd/result/report38.php
30
Estimated salt intake is decreased.
2020 | Year | 06 | Month | 10 | Day |
Healthy Adults
29 participants completed
No adverse effect reported
Estimated salt intake
Completed
2018 | Year | 10 | Month | 22 | Day |
2018 | Year | 10 | Month | 22 | Day |
2018 | Year | 11 | Month | 09 | Day |
2019 | Year | 01 | Month | 04 | Day |
2018 | Year | 11 | Month | 09 | Day |
2020 | Year | 06 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039726
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