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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042421
Receipt No. R000048424
Scientific Title Influence of coix seed on immune cells
Date of disclosure of the study information 2020/11/11
Last modified on 2020/11/20

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Basic information
Public title Influence of coix seed on immune cells
Acronym Influence of coix seed on immune cells
Scientific Title Influence of coix seed on immune cells
Scientific Title:Acronym Influence of coix seed on immune cells
Region
Japan

Condition
Condition Healthy subject
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the Influence of coix seed on immune cells.
Basic objectives2 Others
Basic objectives -Others Influence
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Immune cells
Key secondary outcomes Intestinal microbiota
Cytokines

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Cooked coix seed, 160 g/day for 7 days.
Interventions/Control_2 None
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
65 years-old >
Gender Male
Key inclusion criteria 1. Aged 20 to 64 years old.
2. Subject who is in good physical condition to safely complete the study.
3. Subject who has received an explanation of the study in advance and is able to understand the content and agree with the purpose.
4. Subject who voluntarily participates with written consent
5. Subject who resides near Amano Clinic (1400-35, Oshikusa, Oshino, Minamitsuru, Yamanashi, Japan).
Key exclusion criteria 1. Subject with severe cardiovascular disorder, liver dysfunction, renal dysfunction, respiratory disorder, endocrine disorder, metabolic disorder, or history of these.
2. Subject with Hepatitis B or C, or history of these.
3. Subject who may cause allergies related to coix seed.
4. Subject whose blood drawn (such as blood donation) exceeding 200 mL within 1 month before the start of this study, or 400 mL within 3 months.
5. Subject with a body temperature of 37.5 degrees Celsius or higher within one week.
6. Subject who participated in another clinical trial within the past 3 months or who are currently participating in another clinical trial.
7. Subject who was judged by the principal investigator inappropriate to participate.
Target sample size 24

Research contact person
Name of lead principal investigator
1st name Yoshio
Middle name
Last name Suzuki
Organization Juntendo University
Division name Graduate School of Health and Sports Science
Zip code 2701695
Address 1-1, Hiragagakuendai, Inzai, Chiba
TEL +81476981001
Email yssuzuki@juntendo.ac.jp

Public contact
Name of contact person
1st name Yoshio
Middle name Suzuki
Last name Suzuki
Organization Juntendo University
Division name Graduate School of Health and Sports Science
Zip code 2701695
Address 1-1, Hiragagakuendai, Inzai, Chiba
TEL +81476981001
Homepage URL
Email yssuzuki@juntendo.ac.jp

Sponsor
Institute Juntendo University, Graduate School of Health & Sports Science
Institute
Department

Funding Source
Organization The National Agriculture and Food Research Organization (NARO)
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 of Juntendo University Graduate School of Sports and Health Science
Address 1-1, Hiragagakuenndai, Inzai, Chiba
Tel +81476981001
Email sc-kyomu@juntendo.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 あまの診療所(山梨県)

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 11 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
2020 Year 11 Month 10 Day
Date of IRB
2020 Year 11 Month 10 Day
Anticipated trial start date
2020 Year 11 Month 12 Day
Last follow-up date
2021 Year 01 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
2020 Year 11 Month 11 Day
Last modified on
2020 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048424

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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