UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045202 |
|---|---|
| Receipt number | R000051633 |
| Scientific Title | A Study of a Test Food on Blood Kinetics with Healthy Adult Subjects. |
| Date of disclosure of the study information | 2021/08/19 |
| Last modified on | 2021/10/28 12:07:02 |
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Basic information
Public title
A Study of a Test Food on Blood Kinetics with Healthy Adult Subjects.
Acronym
A Study of a Test Food on Blood Kinetics with Healthy Adult Subjects.
Scientific Title
A Study of a Test Food on Blood Kinetics with Healthy Adult Subjects.
Scientific Title:Acronym
A Study of a Test Food on Blood Kinetics with Healthy Adult Subjects.
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine an effect of a test food on blood kinetics with healthy adult subjects.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood kinetics
(before ingestion, and 30minutes 1,2 hours after ingestion.)
Key secondary outcomes
*Secondary indexes
[1] Body measurements (1)
[2] Vital signs (1)
[3] Hematologic test (1)
[4] Blood biochemical test (1)
[5] Urine analysis (1)
[6] Doctor's questions (2)
(1):Before ingestion.
(2):Before ingestion, and 2 hours after ingestion.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
Single ingestion of the test food (individuals who have no experience to ingest a food with a component).
Interventions/Control_2
Oral ingestion of the test food (individuals who have an experience to ingest a food with a component for 13 days from 2 weeks before the test-day until the day before the test-day, 8 tablets in a day).
> Single ingestion of the test food (individuals who have no experience to ingest a food with a component).
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
[1] Males and females aged 20-69 years working at DKS Co., Ltd..
[2] Individuals whose written informed consent has been obtained.
Key exclusion criteria
[1] Individuals who are patients of lifestyle disease (ex. high blood pressure and diabetes), rheumatism, hepatic disorder, kidney disorder and other chronic diseases and take medicine.
[2] Individuals who have a history of medical treatment of malignancy, heart failure, heart infarction.
[3] Individuals who have a history of allergies of a food or medicine including a component of the test food.
[4] Females who are pregnant or lactating, or want to become pregnant.
[5]Individuals who is participating or participated in other clinical studies in the past 3 months.
[6] Individuals who cannot obey instructions by the principal or medical staffs.
[7] Individuals judged inappropriate for the study by the principal.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Natsuo |
| Middle name | |
| Last name | Shoji |
Organization
DRC Clinic
Division name
Managing Doctor
Zip code
530-0038
Address
2-6 Kobaicho Kita-ku, Osaka-shi, Osaka 530-0038, JAPAN
TEL
+81-800-200-5022
furusyo@drc-web.co.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Saito |
Organization
DKS Co. Ltd.
Division name
Life Sciences Business Headquarters
Zip code
601-8391
Address
5 Kisshoinogawaracho, Minami-ku, Kyoto 601-8391, JAPAN
TEL
+81-75-326-7572
Homepage URL
d.saito@dks-web.co.jp
Sponsor or person
Institute
DRC Clinic
Institute
Department
Personal name
Funding Source
Organization
DKS 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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81528382485
i.takahashi@tes-h.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 | 08 | Month | 19 | 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
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | 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 | 08 | Month | 19 | Day |
Last modified on
| 2021 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051633
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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