UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054519 |
|---|---|
| Receipt number | R000062292 |
| Scientific Title | Verification of the effects of test food intake on mental health : Placebo-controlled, double-blind, randomized, parallel-group comparison study |
| Date of disclosure of the study information | 2024/05/30 |
| Last modified on | 2024/05/30 18:03:57 |
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Basic information
Public title
Verification of the effects of test food intake on mental health
Acronym
Verification of the effects of test food intake on mental health
Scientific Title
Verification of the effects of test food intake on mental health
: Placebo-controlled, double-blind, randomized, parallel-group comparison study
Scientific Title:Acronym
Verification of the effects of test food intake on mental health
: Placebo-controlled, double-blind, randomized, parallel-group comparison study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Ingest the test food for 4 weeks and verify the effect on mental health.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire
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
Ingestion of test food for 12 weeks.
Interventions/Control_2
Ingestion of placebo food 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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Subjects of Japanese men and women aged 20 to 59.
2)Healthy subjects (Healthy subjects in this study are defined as those who do not have any serious organ disorder or disease, and are not receiving any treatment related to such disorder or disease, or are not receiving any drug therapy. (Whether or not a person qualifies as a healthy person is based on the person's report at the start of the study.)
3)Subject who are easily irritated.
4)Subject who are prone to mental distress
5)Subject who do not feel a strong sense of well-being.
Key exclusion criteria
1)Subject who are pregnant or lactating and those who may become pregnant during the study period
2)Subject suspected of having, or with a history of, serious gastrointestinal, hepatic, renal, circulatory, hematological, endocrine system, or malignant neoplasm diseases
3)Subject taking anti-anxiety medication, antidepressants, autonomic nerve regulators, or sleeping pills
4)Subject with or suspected of having a mental disorder such as depression
5)Subject who are or have been continuously taking health foods or supplements claiming to improve the state of mind, sleep, stress, or fatigue in the past month.
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | Yumi |
| Middle name | |
| Last name | Takeda |
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
yumi_takeda@kewpie.co.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Oe |
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
mariko_oe@kewpie.co.jp
Sponsor or person
Institute
Shiba Palace Clinic
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
Shiba Palace Clinic Ethics Review Committee.
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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 | 05 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 30 | 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 | 05 | Month | 30 | Day |
Last modified on
| 2024 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062292
