UMIN-CTR Clinical Trial

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	19
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	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	2021 Year 05 Month 03 Day

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