UMIN-CTR Clinical Trial

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
Email	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
Email	tsudukit@tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043069