UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040970 |
|---|---|
| Receipt number | R000045075 |
| Scientific Title | Safety evaluation study of food containing plant extract |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2022/04/13 18:45:27 |
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Basic information
Public title
Safety evaluation study of food containing plant extract
Acronym
Safety evaluation study of food containing plant extract
Scientific Title
Safety evaluation study of food containing plant extract
Scientific Title:Acronym
Safety evaluation study of food containing plant extract
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to confirm the safety of taking the test food for 12 consecutive weeks
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Side effects and adverse events
(Physical measurements, blood tests, urinalysis, vitals, doctor consultation)
Key secondary outcomes
RBMT(The Rivermead Behavioral Memory Test)
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
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of the test food for 12 weeks (3 tablets / day)
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Japanese male and female over 40 years old at the time of the informed consent.
2)Subjects who do not take medication or health food continuously.
3)Subjects whose Moca-J score is ranged from 18 to 28 before intake of the test food.
4) Subjects who have received a sufficient explanation of the purpose and contents of the examination, have the ability to make a self-judgment, voluntarity participate in the study after understanding the content enough and agree to participate in the study by signing the written informed consent.
5) Subjects who are able to visit the hospital regularly and are able to take the test food at home.
Key exclusion criteria
1) Subjects who have an allergy to the test food.
2) Subjecte whose GDS score is more than 10 before intake of the test food.
3)Subjects who has participated in other clinical studies (clinical trials) within 3 months before the start of the test or who is planning to participate in other clinical studies (clinical trials) during the study period.
4) Subjects who is current disease or a history of diabetes, liver disease (hepatitis), renal disease, serious diseases such as heart disease, thyroid disease, adrenal disease, or other metabolic diseases.
5)Subjects who are judged as unsuitable for the study by principal investigator or sub-investigator.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | tazuo |
| Middle name | |
| Last name | okuno |
Organization
Kanazawa Medical University
Division name
Department of Geriatrics
Zip code
920-0293
Address
1-1 University, Uchinada town, Kahoku county, Ishikawa
TEL
076-286-2211
ma6-0219@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Hama |
Organization
Kanazawa Medical University Hospital
Division name
Dementia Center
Zip code
920-0293
Address
1-1 University, Uchinada town, Kahoku county, Ishikawa
TEL
076-286-3511
Homepage URL
hama-d@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Maruzen Pharmaceuticals 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 ethical committees of the Kanazawa Medical University
Address
1-1 University, Uchinada town, Kahoku county, Ishikawa
Tel
076-218-8346
tiken@kanazawa-med.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 | 07 | Month | 01 | 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
| 2020 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | 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
| 2020 | Year | 07 | Month | 01 | Day |
Last modified on
| 2022 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045075
| 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 |
