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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037197
Receipt No. R000042197
Scientific Title Study on the significance of human blood plant sterol analysis 1
Date of disclosure of the study information 2019/06/30
Last modified on 2019/08/22

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Basic information
Public title Study on the significance of human blood plant sterol analysis 1
Acronym Study on the significance of human blood plant sterol analysis 1
Scientific Title Study on the significance of human blood plant sterol analysis 1
Scientific Title:Acronym Study on the significance of human blood plant sterol analysis 1
Region
Japan

Condition
Condition Healthy adults and mild obese
Classification by specialty
Medicine in general Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 This study analyzes the correlation between the plant sterol level and various biological parameters using the plant sterol level in blood as an index of intake of plant food, and reveals the effectiveness of consumption of plant food .
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between blood plant sterol concentration and various biological parameters (body composition, blood biochemical parameters, aging and inflammation parameters, metabolites)
Key secondary outcomes Correlation between blood plant sterol concentration and intake of vegetable food

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
75 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 180

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 Japanese Governmental office
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 06 Month 30 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 177
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 04 Month 01 Day
Date of IRB
2019 Year 06 Month 21 Day
Anticipated trial start date
2019 Year 07 Month 01 Day
Last follow-up date
2019 Year 08 Month 01 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 06 Month 27 Day
Last modified on
2019 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042197

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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