UMIN-CTR Clinical Trial

Basic information
Public title	A study to compare the absorbency after test food intake.
Acronym	A study to compare the absorbency after test food intake.
Scientific Title	A study to compare the absorbency after test food intake.
Scientific Title:Acronym	A study to compare the absorbency after test food intake.
Region	Japan

Condition
Condition	None
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the absorbability of three types of test foods.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	AUC Cmax
Key secondary outcomes	Tmax T1/2

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Single intake of food A and placebo-Wash out-Single intake of food B-Wash out-Single intake of food C and placebo
Interventions/Control_2	Single intake of food B-Wash out-Single intake of food C and placebo-Wash out-Single intake of food A and placebo
Interventions/Control_3	Single intake of food C and placebo-Wash out-Single intake of food A and placebo-Wash out-Single intake of food B
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	1)Japanese healthy males and females aged from 20 to 59 years old 2)Subjects who can visit the medical institution where the test is conducted on the scheduled visit date and can be hospitalized for 2 nights and 3 days in this test 3)Subjects who have an ability to understand the purpose and contents of this clinical trial and voluntarily applied and agreed to participate in this clinical trial after the explanation of this clinical trial
Key exclusion criteria	1)Subjects who regularly use foods containing the ingredients used in this test 2)Subjects who usually intake a food for specified health use, functional food and health foods 3)Subjects who weigh 40 kg or less or 100 kg or more, or who have a BMI of 31 or more 4)Subjects who are under treatment or have a history of serious heart disease, lung disease, gastrointestinal disease, hypertension, diabetes, or malignant neoplasms 5)Subjects who usually intake drug 6)Subjects who are pregnant, lactation, or planning to become pregnant 7)Subjects who are sensitive to test product or other foods, and medical products 8)Subjects who have collected more than 200 mL of blood 4 weeks before the Screening test or 400 mL of blood before 16 weeks before the Screening test 9)Subjects who have had a bad mood or poor physical condition due to blood sampling in the past 10)Subjects who participated in other clinical studies 11)Subjects who are judged as unsuitable for this study by the principal investigator for other reasons
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Kazumoto Middle name Last name Sasaki
Organization	Medical Corporation Ichigenkai
Division name	Sasaki Memorial Hospital
Zip code	359-1144
Address	1-7-25, Nishitokorozawa, Tokorozawa Shi, Saitama Ken, Japan
TEL	04-2923-1123
Email	soumuka@sasaki-memorial.com

Public contact
Name of contact person	1st name Fukuko Middle name Last name Kubota
Organization	APO PLUS STATION CO., LTD.
Division name	CRO Department Clinical Operations Division
Zip code	103-0027
Address	2-14-1,Nihonbashi,Chuo-ku,Tokyo, JAPAN
TEL	03-6386-8809
Homepage URL
Email	food-contact@apoplus.co.jp

Sponsor
Institute	APO PLUS STATION CO., LTD.
Institute
Department

Funding Source
Organization	THERAVALUES 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	Kanazawabunko Hospital IRB
Address	2-6-22,Kamariyahigashi,Kanazawa-ku,Yokohama-shi,Kanagawa-ken,Japan
Tel	045-785-3311
Email	h.itou@kanabun-hp.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 12 Month 12 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	24
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 11 Month 27 Day
Date of IRB	2020 Year 11 Month 27 Day
Anticipated trial start date	2020 Year 12 Month 12 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	2020 Year 12 Month 10 Day
Last modified on	2021 Year 05 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048757