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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

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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
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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