Unique ID issued by UMIN | UMIN000053868 |
---|---|
Receipt number | R000061490 |
Scientific Title | Setting of test food intake |
Date of disclosure of the study information | 2024/03/14 |
Last modified on | 2024/03/14 19:04:00 |
Setting of test food intake
Setting of test food intake
Setting of test food intake
Setting of test food intake
Japan |
Healthy adult
Not applicable | Adult |
Others
NO
The intake is determined by having the subject ingest the test food and observing the increase in blood amino acid concentration after ingestion
Safety,Efficacy
Exploratory
Not applicable
blood amino acid concentration
Body composition
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Dose comparison
2
Prevention
Food |
Consecutive intake of 10g of test food once a day for 15 days
Consecutive intake of 20g of test food once a day for 15 days
18 | years-old | <= |
29 | years-old | >= |
Male and Female
(1) Healthy males and females from 18 to 29 years of age
(2) Subjects whose BMI is less than 20 kg/m2
(3) Subjects who defecate more than 3 times a week without laxative
(4) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
(1) Subjects who have a positive or false positive result in any infectious disease test or who are carriers
(2) Subjects who have a soybean allergy or who have experienced symptoms such as rash, redness, or difficulty in breathing due to eating soybean products containing soybean flour or soy milk
(3) Subjects who may develop allergies in relation to the study
(4) Subjects who are taking healthy foods
(5) Subjects who are prescribed laxatives or medicines or quasi-drugs that affect the intestinal flora and are taking them more than once a month
(6) Subjects who have with a disease being treated (excluding dry eye/caries treatment) or a disease requiring treatment (grade II hypertension, diabetes, etc.)
(7) Subjects who have had abnormalities in clinical laboratory values or cardiopulmonary function, and are judged to have a problem participating in the study
(8) Subjects who have a disease that requires constant medication (seasonal medication etc.), those who have a disease under treatment, those who have a history of serious disease that required medication, and those who are scheduled for surgery
(9) Subjects whose physical measurements, physical examination values, and clinical examination values before the start of intake were significantly out of the reference range
(10) Subjects who work in shifts, work late at night, and have an irregular daily rhythm before the test day, or subjects who living conditions do not allow them to consume test food every day during the designated period
(11) Subjects who are participating in the other study within one month before the start of this study
(12) Subjects who plan overseas trip, domestic long-term trip or domestic frequent trips
(13) Subjects who plan to become pregnant or breastfeed during the study period
(14) Subjects who are judged to be unsuitable as subjects based on the answers to the background survey
(15) Subjects who are judged as unsuitable for the study by the investigator for other reason
30
1st name | Eiichiro |
Middle name | |
Last name | Naito |
Yakult Honsha Co., Ltd.
Research & Development Division
186-8650
5-11 Izumi, Kunitachi-shi, Tokyo
042-577-8969
eiichiro-naito@yakult.co.jp
1st name | Kaori |
Middle name | |
Last name | Yoshimura |
EP Mediate Co., Ltd.
R&D Support Center Foods Department Trial Planning Section 1
162-0821
Kagurazaka AK Bldg., 1-8 Tsukudocho, Shinjuku-ku, Tokyo
080-1193-3234
yoshimura.kaori265@eps.co.jp
EP Mediate Co., Ltd.
Yakult Honsha Co., Ltd.
Profit organization
Japan
Medical Station Clinic Research Ethics Committee
3-12-8, Takaban, Meguro-ku, Tokyo
03-6452-2712
nakagawa.akiko297@eps.co.jp
NO
メディカルステーションクリニック
2024 | Year | 03 | Month | 14 | Day |
Unpublished
Preinitiation
2024 | Year | 03 | Month | 14 | Day |
2024 | Year | 03 | Month | 14 | Day |
2024 | Year | 03 | Month | 15 | Day |
2024 | Year | 06 | Month | 07 | Day |
2024 | Year | 03 | Month | 14 | Day |
2024 | Year | 03 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061490
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |