UMIN-CTR Clinical Trial

Basic information
Public title	Studies on the pharmacokinetics of useful ingredients after intake of processed food derived from natural products for healthy subjects
Acronym	Studies on the pharmacokinetics of useful ingredients after intake of processed food derived from natural products for healthy subjects
Scientific Title	Studies on the pharmacokinetics of useful ingredients after intake of processed food derived from natural products for healthy subjects
Scientific Title:Acronym	Studies on the pharmacokinetics of useful ingredients after intake of processed food derived from natural products for healthy subjects
Region	Japan

Condition
Condition	healthy subject
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aim to evaluate the pharmacokinetics of useful ingredients in blood after a single intake test of processed food derived from natural products.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood carotenoid contents Amino acid contents in blood Changes in blood antioxidant index
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Single ingestion of processed food derived from natural products with known concentrations of useful ingredients
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	18 years-old <=
Age-upper limit	60 years-old >
Gender	Male
Key inclusion criteria	1.Persons who were obtained written consent based on the subject's free will for participating in this study after receiving a sufficient explanation. 2.In principle, persons who are in their thirties at the time of obtaining consent. 3.Persons who live near the implementation facility.
Key exclusion criteria	1. Persons who suspected of impaired renal function. 2. Persons who may develop allergies related to the test 3. Persons who are with smoking habits. 4. Persons who have participated in other clinical studies at the start of this study. 5.Persons who are judged to be inappropriate by the investigator.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Tetsuo Middle name Last name Nomiyama
Organization	Shinshu university school of medicine
Division name	Department of preventive medicine and public health
Zip code	390-8621
Address	Asahi 3-1-1, Matsumoto, Nagano, Japan
TEL	0263-37-2622
Email	nomiyama@shinshu-u.ac.jp

Public contact
Name of contact person	1st name Hirokazu Middle name Last name Toubou
Organization	Shinshu university school of medicine
Division name	Department of preventive medicine and public health
Zip code	390-8621
Address	Asahi 3-1-1, Matsumoto, Nagano, Japan
TEL	0263-37-2622
Homepage URL
Email	htoubou@shinshu-u.ac.jp

Sponsor
Institute	Shinshu university
Institute
Department

Funding Source
Organization	Hagihara Farm Production Institute Co., Ltd
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	the Ethics Review Committee of Shinshu University School of Medicine
Address	Asahi 3-1-1, Matsumoto, Nagano, Japan
Tel	0263-37-2572
Email	mdrinri@shinshu-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 09 Month 03 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	10
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 07 Month 09 Day
Date of IRB	2020 Year 08 Month 03 Day
Anticipated trial start date	2020 Year 09 Month 01 Day
Last follow-up date	2020 Year 10 Month 03 Day
Date of closure to data entry	2020 Year 11 Month 06 Day
Date trial data considered complete	2020 Year 11 Month 16 Day
Date analysis concluded	2022 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date	2020 Year 09 Month 03 Day
Last modified on	2022 Year 03 Month 31 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047561