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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043379
Receipt No. R000049530
Scientific Title To investigate the effect of the test food on blood kinetics of the indicator components A and B. -Randomized, double-blind, two-drug, two-stage crossover study-
Date of disclosure of the study information 2021/02/24
Last modified on 2021/02/19

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Basic information
Public title To investigate the effect of the test food on blood kinetics of the indicator components A and B.
-Randomized, double-blind, two-drug, two-stage crossover study-
Acronym To investigate the effect of the test food on blood kinetics of the indicator components A and B.
Scientific Title To investigate the effect of the test food on blood kinetics of the indicator components A and B.
-Randomized, double-blind, two-drug, two-stage crossover study-
Scientific Title:Acronym To investigate the effect of the test food on blood kinetics of the indicator components A and B.
Region
Japan

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

Objectives
Narrative objectives1 To investigate the effect of the test food on blood kinetics of the indicator components A and B.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Area under the blood concentration-time curve of A.
Key secondary outcomes Blood concentration of A and B at each time point after ingestion of the test food.
Cmax,Tmax of A.
AUC,Cmax,Tmax of B.

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
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-Intake of control food.
Interventions/Control_2 Intake of control food-Intake of test food.
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
50 years-old >
Gender Male and Female
Key inclusion criteria 1.Between the ages of 20 and 50 years old.
2.Japanese males and females.
Key exclusion criteria 1.Subjects who have a history of or undergoing treatment for a serious disease.
2.Subjects who have a history of or undergoing treatment for diseases that affect digestion and absorption.
3.Subjects who have a history of gastrointestinal resection surgery, excluding appendicectomy.
4.Subject who can`t discontinue health foods, supplements, or medications that may affect the study during the study period.
5.Subjects who may have allergies related to the test food.
6.Subjects who have a smoking habit.
7.Subjects who have difficulty in taking blood samples.
8. Subjects who are pregnant or plan to become pregnant or breastfeed during this study.
9.Subjects who are judged by principal investigator or the person in charge to be unsuitable as subjects.
Target sample size 14

Research contact person
Name of lead principal investigator
1st name Kei
Middle name
Last name Yui
Organization FANCL Corporation
Division name Research Institute, Health science research center
Zip code 244-0806
Address 12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
TEL 045-820-3755
Email ke-yui@fancl.co.jp

Public contact
Name of contact person
1st name Mizuki
Middle name
Last name Watanabe
Organization FANCL Corporation
Division name Research Institute, Health science research center
Zip code 244-0806
Address 12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
TEL 045-820-3510
Homepage URL
Email mizuki1604@fancl.co.jp

Sponsor
Institute FANCL Corporation
Institute
Department

Funding Source
Organization FANCL 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 Clinical Research Ethics Committee of FANCL Corporation
Address 12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
Tel 045-820-3657
Email akihide_nisihara@fancl.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 02 Month 24 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
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 Preinitiation
Date of protocol fixation
2021 Year 02 Month 18 Day
Date of IRB
2021 Year 02 Month 18 Day
Anticipated trial start date
2021 Year 02 Month 24 Day
Last follow-up date
2021 Year 03 Month 26 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 19 Day
Last modified on
2021 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049530

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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