UMIN-CTR Clinical Trial

Basic information
Public title	Changes in plasma concentration of flavonoids after ingestion of flavonoid-rich meal using daily ingredients
Acronym	Changes in plasma concentration of flavonoids after ingestion of flavonoid-rich meal using daily ingredients
Scientific Title	Changes in plasma concentration of flavonoids after ingestion of flavonoid-rich meal using daily ingredients
Scientific Title:Acronym	Changes in plasma concentration of flavonoids after ingestion of flavonoid-rich meal using daily ingredients
Region	Japan

Condition
Condition	Healty adult males
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the absorption rate and plasma concentration of flavonoids after consuming composite flavonoid-rich meals.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	plasma concentration of flavonoids
Key secondary outcomes	flavonoids content in the urine

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	consuming the flavonoid-rich meal
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	Subjects who are given informed consent
Key exclusion criteria	medicated person (like antihypertensive drug) during mensturation
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Yoko Middle name Last name Ichikawa
Organization	Graduate school of integrated pharmaceutical and nutritional sciences, University of Shizuoka
Division name	Laboratory of Food Management
Zip code	422-8526
Address	52-1, Yada, Suruga-ku, Shizuoka
TEL	054-264-5512
Email	ichity@u-shizuoka-ken.ac.jp

Public contact
Name of contact person	1st name Yoko Middle name Last name Ichikawa
Organization	University of Shizuoka
Division name	Graduate school of integrated pharmaceutical and nutritional sciences
Zip code	422-8526
Address	52-1, Yada, Suruga-ku, Shizuoka
TEL	054-264-5512
Homepage URL
Email	ichity@u-shizuoka-ken.ac.jp

Sponsor
Institute	University of Shizuoka
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Ethics Committee of the University of Shizuoka
Address	52-1, Yada, Suruga-ku, Shizuoka
Tel	054-264-5512
Email	tyous10@u-shizuoka-ken.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	2019 Year 06 Month 07 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	7
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	2018 Year 05 Month 01 Day
Date of IRB	2018 Year 06 Month 11 Day
Anticipated trial start date	2019 Year 06 Month 01 Day
Last follow-up date	2019 Year 07 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	2019 Year 06 Month 07 Day
Last modified on	2019 Year 12 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042154