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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000047640 |
Receipt No. | 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 | 2022/05/06 |
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 |
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Condition | |||
Condition | None | ||
Classification by specialty |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 10 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | APO PLUS STATION CO., LTD. |
Institute | |
Department |
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 |
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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 | No longer recruiting | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | 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 |