UMIN-CTR Clinical Trial

Basic information
Public title	Absorbency confirmation test of food ingredients
Acronym	Absorbency confirmation test of food ingredients
Scientific Title	Absorptivity confirmation test in single ingestion of food ingredients for healthy adults
Scientific Title:Acronym	Absorptivity confirmation test in single ingestion of food ingredients for healthy adults
Region	Japan

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

Objectives
Narrative objectives1	To compare blood kinetics of food ingredients with control ingredients in healthy adult male
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of blood kinetics of food ingredients with control ingredients
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Double blind -all involved are 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	Intake of test food (single ingestion) - washout period - control food (single ingestion)
Interventions/Control_2	Intake of control food (single ingestion) - washout period - test food (single ingestion)
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	65 years-old >
Gender	Male
Key inclusion criteria	Healthy males from 20 to under 65 years of age
Key exclusion criteria	(1) Subjects who routinely use health food containing participating component (2) Subjects who cannot carry out inspection procedure as prescribed (3) Subjects who have under treatment or a history of serious disease (4) Subjects having possibilities for emerging allergy related to the test food (5) Subjects who donated over 200mL blood or blood components within the last one month to the current study. (6) Subjects who donated over 400mL blood within the last three months to the current study. (7) Subjects who will be collected over 1200mL blood, when the sampling amounts within the last twelve months are adding to the planned sampling amounts of this study. (8) Subjects who are judged as unsuitable for the current study based on the results of clinical and physical preliminary examination (9) Subjects who have participated in other clinical studies within the last one month prior to the current study or are planned to participate in other studies after obtaining informed consent for the current study (10) Subjects who are judged as unsuitable for the current study based on the results of lifestyle questionnaire (11) Subjects judged as unsuitable for the current study by the investigator
Target sample size	8

Research contact person
Name of lead principal investigator	1st name Masamitsu Middle name Last name Moriwaki
Organization	Taiyo Kagaku Co., Ltd.
Division name	Nutrition division
Zip code	510-0844
Address	1-3, Takara-cho, Yokkaichi-shi, Mie
TEL	059-347-5411
Email	mmoriwaki@taiyokagaku.co.jp

Public contact
Name of contact person	1st name Ryo Middle name Last name Nakagawa
Organization	Taiyo Kagaku Co., Ltd.
Division name	Nutrition division
Zip code	510-0844
Address	1-3, Takara-cho, Yokkaichi-shi, Mie
TEL	059-347-5411
Homepage URL
Email	rnakagawa@taiyokagaku.co.jp

Sponsor
Institute	TTC Co., Ltd
Institute
Department

Funding Source
Organization	Taiyo Kagaku Co., Ltd.
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	Aisei Hospital Ueno Clinic Research Ethics Committee
Address	2-18-6, Higashiueno, Taitou-ku, Tokyo
Tel	03-6455-0880
Email	t.saito@ttc-smo.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 11 Month 14 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	2019 Year 11 Month 14 Day
Date of IRB	2019 Year 11 Month 14 Day
Anticipated trial start date	2019 Year 11 Month 15 Day
Last follow-up date	2019 Year 11 Month 29 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 11 Month 14 Day
Last modified on	2019 Year 12 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043874