UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037529 |
|---|---|
| Receipt number | R000042786 |
| Scientific Title | An effectiveness confirmation test of test food consumption |
| Date of disclosure of the study information | 2020/07/29 |
| Last modified on | 2020/10/09 11:53:38 |
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Basic information
Public title
An effectiveness confirmation test of test food consumption
Acronym
An effectiveness confirmation test of test food consumption
Scientific Title
An effectiveness confirmation test of test food consumption
Scientific Title:Acronym
An effectiveness confirmation test of test food consumption
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm effectiveness on blood miRNA in human by consumption of test food.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Level of blood miRNA
Key secondary outcomes
Level of blood total protein
Level of blood albumin
Level of blood AST
Level of blood ALT
Level of blood LDH
Level of blood total bilirubin
Level of blood ALP
Level of blood gamma-GTP
Level of blood CPK
Level of blood BUN
Level of blood CRE
Level of blood UA
Level of blood Na
Level of blood Cl
Level of blood K
Level of blood Ca
Level of blood total cholesterol
Level of blood LDL-cholesterol
Level of blood HDL-cholesterol
Level of blood triglyceride
Level of blood glucose
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake two tablets of test food which contain pterostilbene for four weeks
Interventions/Control_2
Intake two tablets of test food which contain pterostilbene for four weeks
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
| 45 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male
Key inclusion criteria
1)Males aged 45-64 years at a time of obtaining informed consent.
2)Subjects who show understanding of the clinical study procedures and agreement with participating this study by written informed consent.
Key exclusion criteria
1)Subjects who are currently receiving medication.
2)Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ).
3)Subjects who have excessive alcohol intake.
4)Subjects who constantly use oral medicines, Food for Specified Health Uses (FOSHU), functional foods, supplements and/or healthy foods having a possibility of affecting test results.
5)Subjects who have extremely irregular dietary habits, have midnight work or irregular shift work.
6)Subjects who have allergy to medicines or foods (especially gelatin).
7)Subjects who are participating the other clinical test, were participating it within the past 4 weeks, or are going to participate it.
8)Subjects who donated over 200mL blood and/or blood components within the last one month to the current study.
9)Subjects who donated over 400mL blood and/or blood components within the last three month to the current study.
10)Subjects who is going to be collected over 1200mL blood and/or blood components which is collected whithin the last 12 month and at this study
11)Subjects judged as unsuitable for the study by the principal or attending investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shukuko |
| Middle name | |
| Last name | Ebihara |
Organization
Chiyoda Paramedical Care Clinic
Division name
Director
Zip code
101-0047
Address
2F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-5548
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Kuriki |
Organization
Kewpie Corporation
Division name
Evaluation & Analysis Sciences Department Institute of Technology Solutions, R&D Division
Zip code
182-0002
Address
2-5-7, Sengawa-Cho, Chofu-Shi, Tokyo 182-0002, Japan.
TEL
03-5384-7759
Homepage URL
daisuke_kuriki@kewpie.co.jp
Sponsor or person
Institute
Kewpie Corporation
Institute
Department
Personal name
Funding Source
Organization
Kewpie 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 of Chiyoda Paramedical Care Clinic
Address
2F Sanwauchikannda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.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
| 2020 | Year | 07 | Month | 29 | 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
100
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 | 07 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 29 | Day |
Last modified on
| 2020 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042786
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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