UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058384 |
|---|---|
| Receipt number | R000066749 |
| Scientific Title | Functionality verification test by continuous intake of test food: a randomized, double blind, placebo-controlled study |
| Date of disclosure of the study information | 2025/07/08 |
| Last modified on | 2025/07/07 11:06:37 |
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Basic information
Public title
Functionality verification test by continuous intake of test food
Acronym
Functionality verification test by continuous intake of test food
Scientific Title
Functionality verification test by continuous intake of test food: a randomized, double blind, placebo-controlled study
Scientific Title:Acronym
Functionality verification test by continuous intake of test food
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verify the functionality of the test food after 12 weeks of continuous consumption
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Saliva tests ( s-IgA, cortisol, oxytocin, DHEA), Body weight and body fat, OSA sleep inventory MA version, VAS, skin image analysis (wrinkles, blemishes, texture), subjective evaluation
Key secondary outcomes
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
Continuous intake of one packet per day of the test food for 12 weeks.
Interventions/Control_2
Continuous intake of one packet per day of the placebo for 12 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
| 40 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Males and females aged of 40-59 years
2.Subjects who often feel tired in their daily lives and those who feel easily fatigued.
3.Subjects who feel that they catch colds easily or get sick easily.
4.Subjects who are able to maintain the daily routine they had before participating in this test.
5.Have obtained written consent to participate in this study of their own free will, based on a thorough understanding of the study.
Key exclusion criteria
1. Subjects who are currently receiving medical treatment or rprescription medication for chronic fatigue or chronic fatigue syndrome.
2. Subjects with a serious disease.
3. Pregnant, lactating, or planning to become pregnant during the study period
4. Subjects who are receiving medical treatment (hormone replacement therapy, drug therapy, exercise therapy, diet therapy, etc.) under the supervision of a physician
5. Subjects who are taking or have taken supplements, functional foods, or medicines that affect the immune system
6. Subjects who take or will take new supplements, functional foods, or medicines that affect immunity, sleep, body fat, or skin during the study period.
7. Subjects with food allergies.
8. Subjects with a history of drug dependence
9. Excessive smokers and excessive alcohol users
10. BMI less than 18.5 or more than 31
11. Subjects who plan to receive any vaccination from 30 days prior to the start of the study through the end of the study period.
12. Subjects who work night shift or rotating day and night shifts.
13. Subjects who have participated in other clinical trials within the past month and those who are scheduled to participate during the study period.
14. Subjects who are deemed inappropriate by the principal investigator.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kaneko |
Organization
Japan Clinical Trial Association
Division name
N.A.
Zip code
1600022
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
info@yakujihou.org
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kaneko |
Organization
Japan Clinical Trial Association
Division name
N.A.
Zip code
1600022
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
Homepage URL
info@yakujihou.org
Sponsor or person
Institute
Japan Clinical Trial Association
Institute
Department
Personal name
Funding Source
Organization
Morishita Jintan 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
Institutional Review Board of Pharmaceutical Law Wisdoms
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
Tel
0364574911
master@yakujihou.net
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
| 2025 | Year | 07 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 07 | Day |
Last modified on
| 2025 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066749
