UMIN-CTR Clinical Trial

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
Email	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
Email	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
Email	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	No longer recruiting
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 05 Month 06 Day

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

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