UMIN-CTR Clinical Trial

Basic information
Public title	Preliminary clinical study for the double-blind competitive examination to analyze the effect of mushroom extract-containing food on the expression of sirtuins in a peripheral blood mononuclear cell and oral mucosa cells.
Acronym	The effect of mushroom extract-containing food on the expression of sirtuins in blood and oral mucosal cells.
Scientific Title	Preliminary clinical study for the double-blind competitive examination to analyze the effect of mushroom extract-containing food on the expression of sirtuins in a peripheral blood mononuclear cell and oral mucosal cells.
Scientific Title:Acronym	The effect of mushroom extract-containing food on the expression of sirtuins in blood and oral mucosal cells.
Region	Japan

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

Objectives
Narrative objectives1	Pilot study for the double-blind competitive examination to analyze the effect of mushroom extract-containing food on the expression of sirtuins in peripheral blood mononuclear cell and oral mucosal cells.
Basic objectives2	Others
Basic objectives -Others	To study the effect of mushroom extract-containing food on the expression of sirtuins.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	To study the methods for collection and transportation of samples, and to establish the methods for the analysis of sirtuin levels on blood and oral mucosal cells.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	mushroom extract containing food
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	69 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy donors without allergy of mushroom food
Key exclusion criteria	allergy of mushroom food
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name Yudoh
Organization	St.Marianna University School of Medicine
Division name	Institute of Medical Science
Zip code	2168512
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki City, Japan
TEL	0449778111
Email	yudo@marianna-u.ac.jp

Public contact
Name of contact person	1st name Kazuo Middle name Last name Yudoh
Organization	St.Marianna University School of Medicine
Division name	Institute of Medical Science
Zip code	2168512
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki City, Japan
TEL	0449778111
Homepage URL
Email	yudo@marianna-u.ac.jp

Sponsor
Institute	St.Marianna University School of Medicine
Institute
Department

Funding Source
Organization	St.Marianna University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	University ethics committee in St. Marianna University School of Medicine
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki City, Japan
Tel	0449778111
Email	k-sienbu.mail@marianna-u.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

Other administrative information
Date of disclosure of the study information	2020 Year 12 Month 08 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	Preinitiation
Date of protocol fixation	2020 Year 11 Month 17 Day
Date of IRB
Anticipated trial start date	2020 Year 12 Month 01 Day
Last follow-up date	2021 Year 03 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 12 Month 07 Day
Last modified on	2020 Year 12 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048704