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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043069


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name