UMIN-CTR Clinical Trial

Basic information
Public title	evaluations for human clock aging
Acronym	evaluations for human clock aging
Scientific Title	Screening of biomarkers for the clock aging in human
Scientific Title:Acronym	Screening of biomarkers for the clock aging in human
Region	Japan

Condition
Condition	healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To search for the blood biomarkers of clock aging in humans.
Basic objectives2	Others
Basic objectives -Others	exploratory study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	A set of molecules in the exosome whose rhythms become abnormal with aging
Key secondary outcomes	sleep habits (sleep diary, questionnaire, actigraphy), sleepiness(wake EEG, subjective ratings), cognitive behavioral functions(test battery), salivary melatonin rhythms, body temperature rhythms

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Behavior,custom Maneuver
Interventions/Control_1	24-hour continuous blood collection, 24-hour constant routine protocol (sustained wakefulness, constant postural maintenance, distributed food intake)
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	79 years-old >=
Gender	Male
Key inclusion criteria	Males aged 20 to 29 years old or aged 60 to 79 years old
Key exclusion criteria	1) Those who have difficulty in blood sampling due to alcohol allergy or vasovagal reflex. 2) Those who have difficulty staying in the laboratory 3) Those who have sleep problems deviating from normal aging changes based on polysomnography, questionnaires, sleep diaries, and actigraphy 4) Those who are taking or have a history of pre-existing medical conditions (cardiovascular, liver, endocrine, brain/neurological, and psychiatric) or therapeutic medications that may affect the outcomes 5) Those who are dependent on alcohol or who have the habit of excessive alcohol consumption 6) Those who have a habit of taking drugs or supplements that affect sleep 7) Those who have experienced across time-zones or shift work at least 6 months prior to the study. 8) Other persons deemed inappropriate by the principal investigator.
Target sample size	18

Research contact person
Name of lead principal investigator	1st name Shingo Middle name Last name Kitamura
Organization	National Center of Neurology and Psychiatry
Division name	Department of Sleep-Wake Disorders
Zip code	1870001
Address	4-1-1, Ogawa-Higashi, Kodaira Tokyo
TEL	042-346-2014
Email	s-kita@ncnp.go.jp

Public contact
Name of contact person	1st name Shingo Middle name Last name Kitamura
Organization	National Center of Neurology and Psychiatry
Division name	Department of Sleep-Wake Disorders
Zip code	1870001
Address	4-1-1, Ogawa-Higashi, Kodaira Tokyo
TEL	042-346-2014
Homepage URL
Email	s-kita@ncnp.go.jp

Sponsor
Institute	National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Center of Neurology and Psychiatry Ethical Committee
Address	4-1-1, Ogawa-Higashi, Kodaira Tokyo
Tel	042-341-2711
Email	ml_rinrijimu@ncnp.go.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 11 Month 19 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	Open public recruiting
Date of protocol fixation	2022 Year 06 Month 07 Day
Date of IRB	2022 Year 06 Month 07 Day
Anticipated trial start date	2022 Year 11 Month 21 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 11 Month 19 Day
Last modified on	2022 Year 11 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056442