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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041910
Receipt No. R000047837
Scientific Title Pharmacokinetic study of food ingredient (SIC-2020-09-SHKBSS)
Date of disclosure of the study information 2020/10/01
Last modified on 2020/09/28

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Basic information
Public title Pharmacokinetic study of food ingredient
(SIC-2020-09-SHKBSS)
Acronym Pharmacokinetic study of food ingredient
(SIC-2020-09-SHKBSS)
Scientific Title Pharmacokinetic study of food ingredient
(SIC-2020-09-SHKBSS)
Scientific Title:Acronym Pharmacokinetic study of food ingredient
(SIC-2020-09-SHKBSS)
Region
Japan

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

Objectives
Narrative objectives1 To understand the changes in blood levels of food ingredient.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Concentration of food ingredient in plasma and blood
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Functional food1, 8 weeks, once a day
Interventions/Control_2 Functional food2, 8 weeks, once a day
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
30 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria (1) Healthy men and women whose are 30 <= years old < 60. Employees of Suntory Holdings Limited, who work at the Suntory World Research Center.
(2) Subjects who can make self-judgment and are voluntarily giving written informed consent.
(3) Subject who are scheduled to come to work on designated days.
Key exclusion criteria (1) Subjects whose systolic blood pressure is less than 90mmHg
(2) Subjects who donated 200 mL of blood and/or blood components within four weeks prior to the current study
(3) Males whose blood was collected more than 400 mL within the last 12 weeks
(4) Females whose blood was collected more than 400 mL within the last 16 weeks
(5) Males whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added
(6) Females whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added
(7) Subjects who are participating in other clinical studies for drug medicine or food, or who finished clinical study within four weeks
(8) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons
Target sample size 28

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Watanabe
Organization SUNTORY GLOBAL INNOVATION CENTER LIMITED
Division name Research Institute
Zip code 619-0284
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL 050-3182-0593
Email H_Watanabe@suntory.co.jp

Public contact
Name of contact person
1st name Hitoshi
Middle name
Last name Okumura
Organization SUNTORY GLOBAL INNOVATION CENTER LIMITED
Division name Research Institute
Zip code 619-0284
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL 050-3182-0685
Homepage URL
Email Hitoshi_Okumura@suntory.co.jp

Sponsor
Institute SUNTORY GLOBAL INNOVATION CENTER LIMITED
Institute
Department

Funding Source
Organization SUNTORY GLOBAL INNOVATION CENTER LIMITED
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Miura Clinic, Medical Corporation Kanonkai IRB
Address Higashitenma Bldg. 9F, 1-7-17 Higashitenma, Kita-ku, Osaka, 530-0044, Japan
Tel 06-6135-5200
Email info@miura-cl.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 10 Month 01 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
2020 Year 09 Month 17 Day
Date of IRB
2020 Year 09 Month 17 Day
Anticipated trial start date
2020 Year 10 Month 01 Day
Last follow-up date
2021 Year 06 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
2020 Year 09 Month 28 Day
Last modified on
2020 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047837

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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