UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to compare the absorbency after food intake containing plant extract for adult males (2)
Title of the study (Brief title)	A study to compare the absorbency after food intake containing plant extract (2)
Region	Japan

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

Objectives
Narrative objectives1	To compare the absorbency of two types of plant extract containing food for healthy adult males
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	AUC Cmax
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Single intake of test food A- single intake of test food B
Interventions/Control_2	Single intake of test food B- single intake of test food A
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
Key inclusion criteria	Healthy males aged 20-60 years
Key exclusion criteria	(1) Subjects having possibilities for emerging allergy related to the study. (2) Subjects who are under medication. (3) Subjects who are under treatment or have a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease). (4) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire. (5) Subjects who constantly take in supplement richly containing licorice extract. (6) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination at the screening. (7) Subjects who have habits affecting research results, such as doing shift work day and night, or Subjects who have a plan that affect research results such as day and night shift work or going overseas. (8) Subjects who have participated in other clinical study within the last one month prior to the current study. (9) Subjects who are difficult to take the test food as instructed. (10) Subjects who donated over 200 ml of blood at least one month before the test started. (11) Subjects who have experience of bad mood or deteriorating physical condition due to blood collection. (12) Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size	24

Research contact person
Name of lead principal investigator	Yo Miyakoshi
Organization	KANEKA CORPORATION
Division name	Pharma & Supplemental Nutrition Solutions Vehicle
Address	1-12-32, Akasaka, Minato-ku, Tokyo
TEL	050-3133-9895
Email	Yo.Miyakoshi@kaneka.co.jp

Public contact
Name of contact person	Shingo Yamamichi
Organization	TTC Co.,Ltd
Division name	Clinical Research Planning Department
Address	Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	s.yamamichi@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd
Institute
Department

Funding Source
Organization	KANEKA CORPORATION
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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 09 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 09 Month 13 Day
Anticipated trial start date	2018 Year 09 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 09 Month 14 Day
Last modified on	2018 Year 12 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038914