UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037764 |
|---|---|
| Receipt number | R000043069 |
| Scientific Title | Study on significance of measuring blood telomere length in humans 1 |
| Date of disclosure of the study information | 2019/08/22 |
| Last modified on | 2020/02/17 17:03:43 |
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Basic information
Public title
Study on significance of measuring blood telomere length in humans 1
Acronym
Study on significance of measuring blood telomere length in humans 1
Scientific Title
Study on significance of measuring blood telomere length in humans 1
Scientific Title:Acronym
Study on significance of measuring blood telomere length in humans 1
Region
| Japan |
Condition
Condition
Healthy adults and mild obese
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This study uses telomere length in blood as an index of aging, analyzes the correlation between telomere length and various biological parameters, and clarifies the significance of telomere length measurement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between telomere length and various biological parameters (body composition, blood biochemical parameters, aging and inflammation parameters, metabolites)
Key secondary outcomes
Correlation between telomere length and food intake
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Aged 50-75 years at informed consent
2) Body-mass index (BMI) 18.5-30 kg/m2
3) Obtained written informed consent from the subjects for the study participation
Key exclusion criteria
1) Pregnancy, nursing or planning to become pregnant during the study (female only)
2) Any other significant medical conditions
3) Uncontrolled metabolic syndrome
4) Severe allergies
5) Participation in other clinical trials at enrollment
6) Any other considered by a study physician to be inappropriate for inclusion
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Tsuduki |
Organization
Tohoku University
Division name
Graduate School of Agricultural Science
Zip code
980-0845
Address
468-1, Aoba, Aramaki, Aoba-ku, Sendai 980-0845, Japan
TEL
+81-22-757-4392
tsudukit@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Tsuduki |
Organization
Tohoku University
Division name
Graduate School of Agricultural Science
Zip code
980-0845
Address
468-1, Aoba, Aramaki, Aoba-ku, Sendai 980-0845, Japan
TEL
+81-22-757-4392
Homepage URL
tsudukit@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
National Agriculture and Food Research Organization
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee on Human Studies at Tohoku University Graduate School of Agriculture
Address
468-1, Aoba, Aramaki, Aoba-ku, Sendai 980-0845, Japan
Tel
022-757-4003
agr-syom@grp.tohoku.ac.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
東北大学（宮城県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 22 | 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
222
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
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 08 | Month | 22 | Day |
Last modified on
| 2020 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043069
