UMIN-ICDS Clinical Trial
| 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 |
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Basic information
Public title
After 16 hours of fasting Verification of the effect of ketones
Acronym
After 16 hours of fasting Verification of the effect of ketones
Scientific Title
After 16 hours of fasting Verification of the effect of ketones
Scientific Title:Acronym
After 16 hours of fasting Verification of the effect of ketones
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To ascertain the effects of ketones after 16 hours of fasting in healthy adult male subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
total ketone body
Key secondary outcomes
beta-Hydroxybutyric acid (3-hydroxybutyric acid)
Acetoacetic acid
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
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.
Key exclusion criteria
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.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Nakamura |
Organization
Medical Corporation Ouryokukai Nihonbashi Sakura Clinic
Division name
department of internal medicine
Zip code
103-0025
Address
1-9-2 Nihonbashikayabacho, Chuo-ku, Tokyo
TEL
03-6661-9061
mail-1@ouryokukai.sakura.ne.jp
Public contact
Name of contact person
| 1st name | Masako |
| Middle name | |
| Last name | Mizuuchi |
Organization
APO PLUS STATION CO., LTD.
Division name
Clinical Operation Department, CRO Business Division
Zip code
103-0027
Address
2-14-1 Nihonbashi, Chuo-ku, Tokyo , Japan
TEL
03-6386-8809
Homepage URL
food-contact@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
ANGFA Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board,Medical Corporation Ouryokukai Nihonbashi Sakura Clinic
Address
1-9-2,Nihonbashikayabacho,Chuo-ku,Tokyo,Japanv
Tel
03-6661-9061
c-irb_ug@neues.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To ascertain the effects of ketones after 16 hours of fasting.
Management information
Registered date
| 2022 | Year | 05 | Month | 02 | Day |
Last modified on
| 2022 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054323
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
