UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049561 |
|---|---|
| Receipt number | R000056442 |
| Scientific Title | Screening of biomarkers for the clock aging in human |
| Date of disclosure of the study information | 2022/11/19 |
| Last modified on | 2022/11/21 15:30:03 |
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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
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
s-kita@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056442
