UMIN-CTR Clinical Trial

Basic information
Public title	Effect of the combined ingestion of plant-derived ingredients on the pharmacokinetic parameter
Acronym	Effect of the combined ingestion of plant-derived ingredients on the pharmacokinetic parameter
Scientific Title	Effect of the combined ingestion of plant-derived ingredients on the pharmacokinetic parameter
Scientific Title:Acronym	Effect of the combined ingestion of plant-derived ingredients on the pharmacokinetic parameter
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the dose-response effect of the ingredients on the pharmacokinetic parameter
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of the pharmacokinetic parameter after the single ingestion. (AUC)
Key secondary outcomes	Evaluation of the pharmacokinetic parameter after the single ingestion. (Cmax, Tmax)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	5
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	control (1) > wash out > control (2) > wash out > test beverage (1) > wash out > test beverage (2) > wash out > test beverage (3)
Interventions/Control_2	control (2) > wash out > test beverage (2) > wash out > test beverage (3) > wash out > test beverage (1) > wash out > control (1)
Interventions/Control_3	test beverage (1) > wash out > test beverage (3) > wash out > control (2) > wash out > control (1) > wash out > test beverage (2)
Interventions/Control_4	test beverage (2) > wash out > test beverage (1) > wash out > control (1) > wash out > test beverage (3) > wash out > control (2)
Interventions/Control_5	test beverage (3) > wash out > control (1) > wash out > test beverage (2) > wash out > control (2) > test beverage (1)
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	59 years-old >=
Gender	Male
Key inclusion criteria	Healthy males BMI <= 18.5 and >= 29.9
Key exclusion criteria	1) history of or under treatment for gastrointestinal disorder 2) under treatment for severe disease 3) taking therapeutic medicine 4) TG > 399mg/dL, T-Cho > 259mg/dL, FBG 125mg/dL > and HbA1c > 6.4%, AST > 50U/L, ALT > 50U/L, g-GTP > 100U/L 5) HBs positive, HCV positive 6) creatinine > 1.29mg/dL, BUN > 22.0mg/dL 7) syphilis positive, HIV positive 8) food allergy 9) shift worker 10) blood donor (> 200 mL within the last month or > 400 mL within the last 3 months) 11) heavy drinker 12) heavy smoker 13) drinking less than 2 cups of tea or coffee per day 14) Subjects who are judged to be inappropriate for the study by the medical doctor
Target sample size	8

Research contact person
Name of lead principal investigator	1st name Masanobu Middle name Last name Hibi
Organization	Kao Corporation
Division name	Biological Science Research
Zip code	131-8501
Address	2-1-3, Bunka, Sumida-ku, Tokyo 131-8501, Japan
TEL	+81-3-5630-7266
Email	hibi.masanobu@kao.com

Public contact
Name of contact person	1st name Sachiko Middle name Last name Oishi
Organization	Kao Corporation
Division name	Biological Science Research
Zip code	131-8501
Address	2-1-3, Bunka, Sumida-ku, Tokyo 131-8501, Japan
TEL	+81-3-5630-7266
Homepage URL
Email	oishi.sachiko@kao.com

Sponsor
Institute	Kao Corporation
Institute
Department

Funding Source
Organization	Kao Corporation
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	Japan Conference of Clinical Research
Address	2-27-17 Minami-ikebukuro, toshima-ku, Tokyo, 171-0022, Japan
Tel	03-6868-7022
Email	kakigi@3h-ms.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	医療法人社団成守会 成守会クリニック（東京都）

Other administrative information
Date of disclosure of the study information	2021 Year 02 Month 08 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	8
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	2016 Year 04 Month 23 Day
Date of IRB	2016 Year 04 Month 23 Day
Anticipated trial start date	2016 Year 04 Month 23 Day
Last follow-up date	2021 Year 01 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 08 Day
Last modified on	2021 Year 02 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049401