UMIN-CTR Clinical Trial

Basic information
Public title	A pharmacokinetic study of flavonoids derived from food
Acronym	A pharmacokinetic study of flavonoids derived from food
Scientific Title	A pharmacokinetic study of flavonoids derived from food
Scientific Title:Acronym	A pharmacokinetic study of flavonoids derived from food
Region	Japan

Condition
Condition	Healthy adult volunteers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the pharmacokinetics of flavonoids derived from food
Basic objectives2	Others
Basic objectives -Others	To evaluate the absorption of food-derived ingredients from the digestive tract
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Time-dependent change of blood flavonoids from administration to 24 hours
Key secondary outcomes	The area under the curve (AUC0-24)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is 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	Single ingestion of 5 tablets of food containing flavonoids
Interventions/Control_2	Single ingestion of 5 tablets of placebo
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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Males and females whose age are 20<= years old when the consent is obtained. (2) Subjects who receive an explanation about this trial in advance, understand the content, agree with the purpose, and obtain the written consent.
Key exclusion criteria	(1) Subjects whose systolic blood pressure is under 90 mmHg. (2) Subjects who fall under any of the following items; A) Subjects with heart, liver, or kidney disease (including complications of other diseases) B) Subjects with a history of cardiovascular disease C) Subjects with diabetes D) subjects with a history of gastrointestinal surgery (gastrectomy, gastrointestinal suture, intestinal resection, etc.) that may affect drug absorption E) Subjects with or suspected gastrointestinal obstruction and gastrointestinal motility F) Subjects with abnormal vomiting reflex G) Subjects with test food or drug allergies (including allergies to alcohol used to disinfect the puncture site) H) Subjects who donated 400 mL or more within 90 days, 200 mL or more within 60 days, or those who donated component blood within 30 days I) Pregnant or potentially pregnant women, and lactating women (3) Subjects who ingested rose hips, strawberries, linden, grapefruit, foods containing St. Jones wort and dietary supplements (including supplements and beverages) within 3 days before the start of this study. (4) Subjects who drink habitually (drinking 40 g of pure alcohol or more twice a week) or who drank within 2 days before the start of this study. (5) Subjects who have a smoking habit and those who smoked within 2 days after the start of this study. (6) Subjects who show a positive reaction with HBs antigen, HCV antibody, syphilis serum reaction and HIV antigen / antibody. (7) Subjects with a lean type (BMI less than 18.5). (8) Subjects who are judged to be unsuitable for the test by the investigator.
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Hirosato Middle name Last name Kawakami
Organization	Morishita Jintan Co.,Ltd.
Division name	Health Care Product Department
Zip code	573-0128
Address	11-1, Tsudayamate 2-Chome, Hirakata City, Osaka
TEL	072-800-1044
Email	h-kawakami@jintan.co.jp

Public contact
Name of contact person	1st name Akifumi Middle name Last name Nagatomo
Organization	Morishita Jintan Co.,Ltd.
Division name	Health Care Product Department
Zip code	573-0128
Address	11-1, Tsudayamate 2-Chome, Hirakata City, Osaka
TEL	072-800-1044
Homepage URL
Email	a-nagatomo@jintan.co.jp

Sponsor
Institute	Morishita Jintan Co.,Ltd.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	International Institute for Integrative Sleep Medicine, University of Tsukuba
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Morishita Jintan Institutional Review Board
Address	11-1, Tsudayamate 2-Chome, Hirakata City, Osaka
Tel	06-6761-1131
Email	y-takeda@jintan.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	2021 Year 03 Month 31 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	Completed
Date of protocol fixation	2021 Year 01 Month 26 Day
Date of IRB	2021 Year 02 Month 08 Day
Anticipated trial start date	2021 Year 02 Month 09 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	2021 Year 02 Month 22 Day
Last modified on	2021 Year 08 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049566