UMIN-CTR Clinical Trial

Basic information
Public title	Pharmacokinetic study of food ingredient (SIC-2020-09-SHKBSS)
Acronym	Pharmacokinetic study of food ingredient (SIC-2020-09-SHKBSS)
Scientific Title	Pharmacokinetic study of food ingredient (SIC-2020-09-SHKBSS)
Scientific Title:Acronym	Pharmacokinetic study of food ingredient (SIC-2020-09-SHKBSS)
Region	Japan

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

Objectives
Narrative objectives1	To understand the changes in blood levels of food ingredient.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Concentration of food ingredient in plasma and blood
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Functional food1, 8 weeks, once a day
Interventions/Control_2	Functional food2, 8 weeks, once a day
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	30 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Healthy men and women whose are 30 <= years old < 60. Employees of Suntory Holdings Limited, who work at the Suntory World Research Center. (2) Subjects who can make self-judgment and are voluntarily giving written informed consent. (3) Subject who are scheduled to come to work on designated days.
Key exclusion criteria	(1) Subjects whose systolic blood pressure is less than 90mmHg (2) Subjects who donated 200 mL of blood and/or blood components within four weeks prior to the current study (3) Males whose blood was collected more than 400 mL within the last 12 weeks (4) Females whose blood was collected more than 400 mL within the last 16 weeks (5) Males whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added (6) Females whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added (7) Subjects who are participating in other clinical studies for drug medicine or food, or who finished clinical study within four weeks (8) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons
Target sample size	28

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Watanabe
Organization	SUNTORY GLOBAL INNOVATION CENTER LIMITED
Division name	Research Institute
Zip code	619-0284
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0593
Email	H_Watanabe@suntory.co.jp

Public contact
Name of contact person	1st name Hitoshi Middle name Last name Okumura
Organization	SUNTORY GLOBAL INNOVATION CENTER LIMITED
Division name	Research Institute
Zip code	619-0284
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0685
Homepage URL
Email	Hitoshi_Okumura@suntory.co.jp

Sponsor
Institute	SUNTORY GLOBAL INNOVATION CENTER LIMITED
Institute
Department

Funding Source
Organization	SUNTORY GLOBAL INNOVATION CENTER LIMITED
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	Miura Clinic, Medical Corporation Kanonkai IRB
Address	Higashitenma Bldg. 9F, 1-7-17 Higashitenma, Kita-ku, Osaka, 530-0044, Japan
Tel	06-6135-5200
Email	info@miura-cl.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 10 Month 01 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 09 Month 17 Day
Date of IRB	2020 Year 09 Month 17 Day
Anticipated trial start date	2020 Year 10 Month 01 Day
Last follow-up date	2021 Year 06 Month 30 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 09 Month 28 Day
Last modified on	2020 Year 09 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047837

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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