UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038870 |
|---|---|
| Receipt number | R000044328 |
| Scientific Title | A study to evaluate the effect of plant-derived ingredients on TTR stability -Exploratory study- |
| Date of disclosure of the study information | 2020/12/15 |
| Last modified on | 2020/05/20 12:44:48 |
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Basic information
Public title
A study to evaluate the effect of plant-derived ingredients on TTR stability -Exploratory study-
Acronym
An exploratory study to evaluate the effect of plant-derived ingredients on TTR stability
Scientific Title
A study to evaluate the effect of plant-derived ingredients on TTR stability -Exploratory study-
Scientific Title:Acronym
An exploratory study to evaluate the effect of plant-derived ingredients on TTR stability
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploratory verification of transthyretin (TTR) stability in the plasma from healthy Japanese who have taken plant-derived ingredients (300 mg / day, 12 weeks intakes)
Basic objectives2
Others
Basic objectives -Others
Verification of the effect of plant-derived ingredients on TTR stability in plasma
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
TTR stability
Key secondary outcomes
None
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 35 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Japanese healty females and males older than 35 years
2) Subjects with stable plasma concentrations of the plant-derived ingredients quantitated at 4, 8, and 12 weeks of intakes
3) Subjects with the high averaged concentration of the plant-derived ingredients quantitated at 4, 8, and 12 weeks of intakes
4) Subjects who agreed in writing prior to the start of the trial with sufficient understanding of the purpose and contents of this study
Key exclusion criteria
1) Subjects judged as unsuitable for this study by the principal investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Iwao |
| Middle name | |
| Last name | Funahashi |
Organization
KANEKA CORPORATION
Division name
Pharma & Supplemental Nutrition Solutions Vehicle
Zip code
107-6028
Address
1-12-32, Akasaka, Minato-ku, Tokyo, Japan
TEL
050-3133-6397
Iwao.Funahashi@kaneka.co.jp
Public contact
Name of contact person
| 1st name | Soichi |
| Middle name | |
| Last name | Yoneda |
Organization
APO PLUS STATION CO., LTD.
Division name
CRO Department Food Test Division
Zip code
103-0027
Address
2-14-1, Nihonbashi, Chuo-ku, Tokyo,
TEL
03-6386-8809
Homepage URL
s-yoneda@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
KANEKA CORPORATION
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
Institutional Review Board,Kanazawabunko Hospital
Address
Kanagawa Prefecture Yokohama City Kanazawa-ku Kaburiya Higashi 2-chome 6-22
Tel
045-785-3311
watanabe@kanabun-hp.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
金内メディカルクリニック（東京都）、上尾中央第二病院（埼玉県）、笛吹中央病院（山梨県）、武蔵境クリニック（東京都）、久野マインズタワークリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 15 | 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
| 2019 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 12 | Month | 13 | Day |
Last modified on
| 2020 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044328
| 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 |
