UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047972 |
|---|---|
| Receipt number | R000054686 |
| Scientific Title | Investigation of the in vivo dynamics of dietary ingredients |
| Date of disclosure of the study information | 2022/06/08 |
| Last modified on | 2023/06/09 18:54:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation of the in vivo dynamics of dietary ingredients
Acronym
Investigation of the in vivo dynamics of dietary ingredients
Scientific Title
Investigation of the in vivo dynamics of dietary ingredients
Scientific Title:Acronym
Investigation of the in vivo dynamics of dietary ingredients
Region
| Japan | Asia(except Japan) |
Condition
Condition
Healty volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims at elucidating the difference in the in vivo dynamics of food ingredients.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dietary peptides in plasma
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake test food
Interventions/Control_2
Intake test food
Interventions/Control_3
Intake test food
Interventions/Control_4
Intake test food
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females whose age of 20 years or more and less than 65 years.
(2) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
(1) Subjects receiving a medical treatment for chronic diseases (dyslipidemia, high blood pressure, diabetes, etc.)
(2) Subjects receiving a medical treatment for serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders.
(3) Subjects who have the possibility of developing allergic symptoms by the test food.
(4) Female subjects who are pregnant or lactating, or intending to become pregnant during the study.
(5) Subjects deemed unsuitable by the investigator.
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Yamashita |
Organization
Pharma Foods International Co.,Ltd.
Division name
R&D Dept.
Zip code
615-8245
Address
1-49 Goryo-Ohara, Nishikyo-ku, Kyoto
TEL
075-748-9829
y-yamashita@pharmafoods.co.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Ide |
Organization
Pharma Foods International Co.,Ltd.
Division name
R&D Dept.
Zip code
615-8245
Address
1-49 Goryo-Ohara, Nishikyo-ku, Kyoto
TEL
075-748-9829
Homepage URL
masahiro-ide@pharmafoods.co.jp
Sponsor or person
Institute
Pharma Foods International Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
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
Pharma Foods International Co.,Ltd. Institutional Review Board
Address
1-49 Goryo-Ohara, Nishikyo-ku, Kyoto
Tel
075-748-9811
t-sakata@pharmafoods.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
株式会社ファーマフーズ（京都府）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
8
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
| 2022 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 06 | Day |
Last modified on
| 2023 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054686
