UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051609 |
|---|---|
| Receipt number | R000058888 |
| Scientific Title | Effect of food ingredient on liver functions A preliminary study |
| Date of disclosure of the study information | 2023/07/14 |
| Last modified on | 2023/07/14 10:00:27 |
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Basic information
Public title
Effect of food ingredient on liver functions
A preliminary study
Acronym
Effect of food ingredient on liver functions
A preliminary study
Scientific Title
Effect of food ingredient on liver functions
A preliminary study
Scientific Title:Acronym
Effect of food ingredient on liver functions
A preliminary study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Preliminary study to examine the effect of food ingredient on liver functions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood markers
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants 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
Ingestion of food ingredient
Duration: 12 weeks
Administration: Take once a day
Interventions/Control_2
Ingestion of placeabo
Duration: 12 weeks
Administration: Take once a day
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Kewpie Group employees who voluntarily wish to participate in the study and provide written consent
2) Men and women between the ages of 20 and 65
3) Those who are concerned about the results of liver function based on the results of health checkups.
Key exclusion criteria
1) Those with serious diseases (diabetes, heart disease, liver disease, renal disease, cancer, etc.) or psychiatric diseases
2) Those who fall under the judgment category of "D" (medical care required*) by the Society of Physical Health and Medical Examination.
3) Those with possible food allergy or drug allergy to the test food
Pregnant or lactating mothers, or those who may be pregnant or lactating
4) Those who are otherwise deemed ineligible by the investigator to participate in this study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 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
TEL
03-5384-7759
ryosuke_matsuoka@kewpie.co.jp
Public contact
Name of contact person
| 1st name | Soyogu |
| Middle name | |
| Last name | Yamashita |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
182-0002
Address
2-5-7, Sengawa-cho, Chofu-shi, Tokyo
TEL
03-5384-7759
Homepage URL
soyogu_yamashita@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
Ueno Asao Clinic Institutional Review Board
Address
6F Kairaku Building, 2-7-5 Higashiueno, Taito-ku, Tokyo
Tel
03-6240-1162
info@ueno-asagao.clinic
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
| 2023 | Year | 07 | Month | 14 | 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
60
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
| 2021 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 07 | Month | 14 | Day |
Last modified on
| 2023 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058888
| 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 |
