UMIN-CTR Clinical Trial

Basic information
Public title	Test for confirmation of absorption of a compound by ingestion of test foods
Acronym	Test for confirmation of absorption of a compound by ingestion of test foods
Scientific Title	Test for confirmation of absorption of a compound by ingestion of test foods
Scientific Title:Acronym	Test for confirmation of absorption of a compound by ingestion of test foods
Region	Japan

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

Objectives
Narrative objectives1	Confirm the difference between origin raw materials and food ingredient in terms of absorption of compound when taken orally.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Concentration of intact components in blood plasma
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	single oral ingestion about 250g of raw material ( fruit eatable part and seed )
Interventions/Control_2	Single oral ingestion 1250mL of food (beverages) containing food ingredients extracted and refined from raw materials.
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 and Female
Key inclusion criteria	(1) Men and women aged 20 to 65 years at the time of obtaining consent (2) BMI of 18.5 kg/m^2or more but less than 30.0 kg/m^2. (3) Those who have completed two doses of the new coronavirus vaccine at least one week prior to the first test day. (4) Those who have received sufficient explanation of the test, understand the contents, and can give written consent in person.
Key exclusion criteria	(1) People who have difficulty with acidity (2) Those who are currently taking any medication. (3) Those who are scheduled to take medication or receive vaccinations between one week before the first test date and the second test date. (4) Heavy drinkers of alcohol (5) Those who are unable to go to bed and sleep as usual the day before the test day (6) Those who have been told that their blood vessels are too thin or that it is difficult to draw blood more than once (7) Those who are aware that they have severe symptoms such as irregular menstruation, menstrual cramps, or symptoms related to menopausal disorders. (8) Those who have a history or current history of serious diseases of the heart, liver, kidneys, digestive organs, etc. (9) Those who are pregnant, lactating, or intend to become pregnant during the study period. (10) Those with allergies to medicines or food (11) Those who are currently participating in a clinical trial of another drug or health food, and plan to participate in another clinical trial within 4 weeks of the end of the trial, or after consenting to participate in the trial. (12) Those who have donated component blood or 200 mL whole blood since the month prior to the start of the study. (13) Men who have donated 400 mL of whole blood for 3 months prior to the start of the study. (14)Women who have donated 400 mL of whole blood for 4 months prior to the start of the study (15) Men whose total blood collection volume exceeds 1200 mL when the planned total blood collection volume for the study is added to the blood collection volume from 12 months prior to the start of the study (16)Women whose blood volume exceeds 800 mL when the total planned blood volume for the study is added to the blood volume collected 12 months prior to the start of the study. (17) Patients who are judged to be inappropriate for participation in the study by the principal investigator or sub-investigator. Translated with www.DeepL.com/Translator (free version)
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Yuko Middle name Last name Matsui
Organization	R&D Institute, MORINAGA & CO., LTD.
Division name	Health Science Research Center
Zip code	230-8504
Address	Shimosueyoshi 2-1-1 Tsurumi-ku Yokohama-si Kanagawa-ken
TEL	045-571-2982
Email	y-matsui-jd@morinaga.co.jp

Public contact
Name of contact person	1st name Sadao Middle name Last name Mori
Organization	R&D Institute, MORINAGA & CO., LTD.
Division name	Health Science Research Center
Zip code	230-8504
Address	Shimosueyoshi 2-1-1 Tsurumi-ku Yokohama-si Kanagawa-ken
TEL	045-571-2982
Homepage URL
Email	s-mori-ab@morinaga.co.jp

Sponsor
Institute	R&D Institute, MORINAGA & CO., LTD.
Institute
Department

Funding Source
Organization	R&D Institute, MORINAGA & 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	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Chushin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
Email	IRB@cpcc.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 10 Month 06 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	10
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	Main results already published
Date of protocol fixation	2021 Year 09 Month 17 Day
Date of IRB	2021 Year 09 Month 17 Day
Anticipated trial start date	2021 Year 09 Month 29 Day
Last follow-up date	2021 Year 11 Month 30 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 09 Month 29 Day
Last modified on	2022 Year 02 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051980