Unique ID issued by UMIN | UMIN000047640 |
---|---|
Receipt number | R000054323 |
Scientific Title | After 16 hours of fasting Verification of the effect of ketones |
Date of disclosure of the study information | 2022/05/02 |
Last modified on | 2022/07/01 18:14:59 |
After 16 hours of fasting Verification of the effect of ketones
After 16 hours of fasting Verification of the effect of ketones
After 16 hours of fasting Verification of the effect of ketones
After 16 hours of fasting Verification of the effect of ketones
Japan |
None
Not applicable | Adult |
Others
NO
To ascertain the effects of ketones after 16 hours of fasting in healthy adult male subjects.
Efficacy
total ketone body
beta-Hydroxybutyric acid (3-hydroxybutyric acid)
Acetoacetic acid
Observational
20 | years-old | <= |
60 | years-old | > |
Male
1) Japanese males between the ages of 20 and 60 years old at the time consent is obtained.
2) Persons with no abnormalities in blood glucose levels (no abnormalities in blood glucose levels ever indicated in a physical examination)
3) BMI between 18.5 kg/m2 and 22.0 kg/m2
4)Persons who are able to come to the hospital fasting, having eaten dinner by 19:00 the previous day in order to obtain values after 16 hours of fasting.
5) The patient must have received a full explanation of the purpose and content of the study and must have signed a consent form prior to the start of the study.
1) Those with a history or current condition (disease) of liver disease, renal disease, cerebrovascular disease, diabetes, dyslipidemia, hypertension, or other chronic disease
2) Currently undergoing treatment for a serious disease
3) The patient is regularly using medicines or quasi-drugs that may affect the test items.
4) Those who regularly use health foods (food for specified health use, nutritional supplements, functional foods, supplements, etc.) that may affect the test items.
5) Those with extremely irregular lifestyles (e.g., working at night or living day and night in reverse)
6) Those who are currently participating in a clinical trial or have participated in another clinical trial within the past 3 months from the date of obtaining consent
7) Those who plan to participate in other clinical trials during the study period
8) Any other person who is judged by the investigator to be unsuitable for the study.
10
1st name | Masahiko |
Middle name | |
Last name | Nakamura |
Medical Corporation Ouryokukai Nihonbashi Sakura Clinic
department of internal medicine
103-0025
1-9-2 Nihonbashikayabacho, Chuo-ku, Tokyo
03-6661-9061
mail-1@ouryokukai.sakura.ne.jp
1st name | Masako |
Middle name | |
Last name | Mizuuchi |
APO PLUS STATION CO., LTD.
Clinical Operation Department, CRO Business Division
103-0027
2-14-1 Nihonbashi, Chuo-ku, Tokyo , Japan
03-6386-8809
food-contact@apoplus.co.jp
APO PLUS STATION CO., LTD.
ANGFA Co.,Ltd.
Profit organization
Institutional Review Board,Medical Corporation Ouryokukai Nihonbashi Sakura Clinic
1-9-2,Nihonbashikayabacho,Chuo-ku,Tokyo,Japanv
03-6661-9061
c-irb_ug@neues.co.jp
NO
2022 | Year | 05 | Month | 02 | Day |
Unpublished
Completed
2022 | Year | 04 | Month | 26 | Day |
2022 | Year | 04 | Month | 26 | Day |
2022 | Year | 05 | Month | 06 | Day |
2022 | Year | 05 | Month | 16 | Day |
To ascertain the effects of ketones after 16 hours of fasting.
2022 | Year | 05 | Month | 02 | Day |
2022 | Year | 07 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054323
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |