UMIN-CTR Clinical Trial

Basic information
Public title	An effectiveness confirmation test of test food consumption
Acronym	An effectiveness confirmation test of test food consumption
Scientific Title	An effectiveness confirmation test of test food consumption
Scientific Title:Acronym	An effectiveness confirmation test of test food consumption
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm effectiveness on blood miRNA in human by consumption of test food.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Level of blood miRNA
Key secondary outcomes	Level of blood total protein Level of blood albumin Level of blood AST Level of blood ALT Level of blood LDH Level of blood total bilirubin Level of blood ALP Level of blood gamma-GTP Level of blood CPK Level of blood BUN Level of blood CRE Level of blood UA Level of blood Na Level of blood Cl Level of blood K Level of blood Ca Level of blood total cholesterol Level of blood LDL-cholesterol Level of blood HDL-cholesterol Level of blood triglyceride Level of blood glucose

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake two tablets of test food which contain pterostilbene for four weeks
Interventions/Control_2	Intake two tablets of test food which contain pterostilbene for four weeks
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	45 years-old <=
Age-upper limit	64 years-old >=
Gender	Male
Key inclusion criteria	1)Males aged 45-64 years at a time of obtaining informed consent. 2)Subjects who show understanding of the clinical study procedures and agreement with participating this study by written informed consent.
Key exclusion criteria	1)Subjects who are currently receiving medication. 2)Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ). 3)Subjects who have excessive alcohol intake. 4)Subjects who constantly use oral medicines, Food for Specified Health Uses (FOSHU), functional foods, supplements and/or healthy foods having a possibility of affecting test results. 5)Subjects who have extremely irregular dietary habits, have midnight work or irregular shift work. 6)Subjects who have allergy to medicines or foods (especially gelatin). 7)Subjects who are participating the other clinical test, were participating it within the past 4 weeks, or are going to participate it. 8)Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. 9)Subjects who donated over 400mL blood and/or blood components within the last three month to the current study. 10)Subjects who is going to be collected over 1200mL blood and/or blood components which is collected whithin the last 12 month and at this study 11)Subjects judged as unsuitable for the study by the principal or attending investigator.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Shukuko Middle name Last name Ebihara
Organization	Chiyoda Paramedical Care Clinic
Division name	Director
Zip code	101-0047
Address	2F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-5548
Email	cpcc-contact@cpcc.co.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Kuriki
Organization	Kewpie Corporation
Division name	Evaluation & Analysis Sciences Department Institute of Technology Solutions, R&D Division
Zip code	182-0002
Address	2-5-7, Sengawa-Cho, Chofu-Shi, Tokyo 182-0002, Japan.
TEL	03-5384-7759
Homepage URL
Email	daisuke_kuriki@kewpie.co.jp

Sponsor
Institute	Kewpie Corporation
Institute
Department

Funding Source
Organization	Kewpie Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Sanwauchikannda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
Email	IRB@cpcc.co.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 07 Month 29 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	100
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 07 Month 21 Day
Date of IRB	2019 Year 07 Month 19 Day
Anticipated trial start date	2019 Year 07 Month 30 Day
Last follow-up date	2019 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 07 Month 29 Day
Last modified on	2020 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042786