![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
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 |
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 |
|
Condition | ||
Condition | Not applicable | |
Classification by specialty |
|
|
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 |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 |
|
||||||
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 | |
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 |
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 |
|
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 |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
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 |