UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054617 |
|---|---|
| Receipt number | R000062407 |
| Scientific Title | Effect of test food consumption on blood microRNA level |
| Date of disclosure of the study information | 2024/06/10 |
| Last modified on | 2024/06/10 13:53:05 |
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Basic information
Public title
Effect of test food consumption on blood microRNA level
Acronym
Effect of test food consumption on blood microRNA level
Scientific Title
Effect of test food consumption on blood microRNA level
Scientific Title:Acronym
Effect of test food consumption on blood microRNA level
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
Blood microRNA level
Key secondary outcomes
Blood biochemical test
Safety evaluation
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake two tablets of test food which contain test component (high dose) for twelve weeks
Interventions/Control_2
Intake two tablets of test food which contain test component (low dose) for twelve weeks
Interventions/Control_3
Intake two tablets of test food which does not contain test component for twelve weeks
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
| 65 | years-old | >= |
Gender
Male
Key inclusion criteria
(1) Healthy adults without serious illness.
(2) Male.
(3) 30 males aged 40-65 years. Subjects who voluntarily wish to participate in clinical trials and agreement with participating this study by written informed consent.
(4) Subjects who can maintain regular daily habits during the test period.
(5) In principle, subjects who are taking medication for treatment of chronic diseases (high blood pressure, etc.) or are going to the hospital are excluded. If the condition is mild, their participation will be considered by the principal investigator.
Key exclusion criteria
(1) Subjects who are currently receiving medication or going to the hospital.
(2) Subjects who have previous medical history of serious disease or chronic disease.
(3) Subjects who have allergy to foods or medicines.
(4) Subjects who were participating other clinical test within the past 1 month.
(5) Subjects who constantly use Food for Specified Health Uses(FOSHU) or functional foods, etc.
(6) Subjects who eat and drink excessively or have extremely irregular dietary habits.
(7) Subjects judged as unsuitable for the study by the principal investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Tanaka |
Organization
Kagawa Nutrition University
Nutrition Clinic
Division name
Director
Zip code
170-8481
Address
3-24-3, Komagome, Toshima-ku, Tokyo, JAPAN
TEL
03-3918-6181
clinic@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | Matsuoka |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
182-0002
Address
2-5-7, Sengawa-Cho, Chofu-Shi, Tokyo, Japan
TEL
03-5384-7759
Homepage URL
ryosuke_matsuoka@kewpie.co.jp
Sponsor or person
Institute
Kagawa Nutrition University
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
The Ethical Committee of Kagawa Nutrition University
Address
3-9-21, Chiyoda, Sakado-Shi, Saitama, Japan
Tel
049-282-1353
kenshien@eiyo.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
| 2024 | Year | 06 | Month | 10 | Day |
Related information
URL releasing protocol
https://www2.aeplan.co.jp/jsnfs2023/contents/program.html
Publication of results
Partially published
Result
URL related to results and publications
https://www2.aeplan.co.jp/jsnfs2023/contents/program.html
Number of participants that the trial has enrolled
30
Results
Although there were no significant improvements in blood microRNA levels due to intake of the test component, some subjects with large fluctuations in microRNA levels, who were considered to be responders, were observed. Regarding blood glucose measurements, the significant increase observed in the control group was not seen in the test component(high dose) group. Thus, test component intake would inhibit the rise in blood glucose levels.
Results date posted
| 2024 | Year | 06 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Males aged 40-65 years.
Participant flow
Of the 30 patients (10 controls, 10 low doses, 10 high doses), 27 patients (10 controls, 9 low doses, 8 high doses) were analyzed.
Adverse events
There is no adverse event.
Outcome measures
Blood microRNA level, Blood biochemical test, Safety evaluation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2017 | Year | 10 | 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
| 2024 | Year | 06 | Month | 10 | Day |
Last modified on
| 2024 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062407
