UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041668 |
|---|---|
| Receipt number | R000047561 |
| Scientific Title | Studies on the pharmacokinetics of useful ingredients after intake of processed food derived from natural products for healthy subjects |
| Date of disclosure of the study information | 2020/09/03 |
| Last modified on | 2022/03/31 10:31:22 |
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Basic information
Public title
Studies on the pharmacokinetics of useful ingredients after intake of processed food derived from natural products for healthy subjects
Acronym
Studies on the pharmacokinetics of useful ingredients after intake of processed food derived from natural products for healthy subjects
Scientific Title
Studies on the pharmacokinetics of useful ingredients after intake of processed food derived from natural products for healthy subjects
Scientific Title:Acronym
Studies on the pharmacokinetics of useful ingredients after intake of processed food derived from natural products for healthy subjects
Region
| Japan |
Condition
Condition
healthy subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aim to evaluate the pharmacokinetics of useful ingredients in blood after a single intake test of processed food derived from natural products.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood carotenoid contents
Amino acid contents in blood
Changes in blood antioxidant index
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single ingestion of processed food derived from natural products with known concentrations of useful ingredients
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
1.Persons who were obtained written consent based on the subject's free will for participating in this study after receiving a sufficient explanation.
2.In principle, persons who are in their thirties at the time of obtaining consent.
3.Persons who live near the implementation facility.
Key exclusion criteria
1. Persons who suspected of impaired renal function.
2. Persons who may develop allergies related to the test
3. Persons who are with smoking habits.
4. Persons who have participated in other clinical studies at the start of this study.
5.Persons who are judged to be inappropriate by the investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Nomiyama |
Organization
Shinshu university school of medicine
Division name
Department of preventive medicine and public health
Zip code
390-8621
Address
Asahi 3-1-1, Matsumoto, Nagano, Japan
TEL
0263-37-2622
nomiyama@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hirokazu |
| Middle name | |
| Last name | Toubou |
Organization
Shinshu university school of medicine
Division name
Department of preventive medicine and public health
Zip code
390-8621
Address
Asahi 3-1-1, Matsumoto, Nagano, Japan
TEL
0263-37-2622
Homepage URL
htoubou@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu university
Institute
Department
Personal name
Funding Source
Organization
Hagihara Farm Production Institute 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
the Ethics Review Committee of Shinshu University School of Medicine
Address
Asahi 3-1-1, Matsumoto, Nagano, Japan
Tel
0263-37-2572
mdrinri@shinshu-u.ac.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 | 09 | Month | 03 | 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
10
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
| 2020 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 03 | Day |
Date of closure to data entry
| 2020 | Year | 11 | Month | 06 | Day |
Date trial data considered complete
| 2020 | Year | 11 | Month | 16 | Day |
Date analysis concluded
| 2022 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 03 | Day |
Last modified on
| 2022 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047561
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
