UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041910 |
|---|---|
| Receipt number | 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 12:52:13 |
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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
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
Hitoshi_Okumura@suntory.co.jp
Sponsor or person
Institute
SUNTORY GLOBAL INNOVATION CENTER LIMITED
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047837
