UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056243 |
|---|---|
| Receipt number | R000064262 |
| Scientific Title | Study on the effects of test foods on mental health |
| Date of disclosure of the study information | 2024/11/26 |
| Last modified on | 2024/11/22 18:44:08 |
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Basic information
Public title
Study on the effects of test foods on mental health
Acronym
Study on the effects of test foods on mental health
Scientific Title
Study on the effects of test foods on mental health
Scientific Title:Acronym
Study on the effects of test foods on mental health
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effects of food intake on mental health
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary oxytocin and cortisol
Key secondary outcomes
TMS,TDMS,VAS
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single administration of test food (Test Food)
Interventions/Control_2
Olfactory exposure to test food (Test Food)
Interventions/Control_3
Single administration of test food (Control Food)
Interventions/Control_4
No treatment
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 25 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy women aged 25 to 45 (at the time of consent)
Participants who usually eat breakfast
Participants who have weekends off from work
Key exclusion criteria
Participants with food allergies
Participants with abnormal smell or taste
Participants who are pregnant or may be pregnant
Participants with a history of mental illness or a current illness
Participants who dislike bread
Participants with dietary restrictions
Participants taking medication
Participants who do not eat bread even once a week
Participants who skip breakfast more than two days a week
Participants who smoke or drink alcohol
Participants with dietary restrictions
Participants taking supplements
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Aida |
Organization
NIPPN CORPORATION
Division name
Innovation Center, Central Research Laboratory
Zip code
243-0041
Address
5-1-3 Midorigaoka, Atsugi City, Kanagawa Prefecture
TEL
042-222-6963
kaida@nippn.co.jp
Public contact
Name of contact person
| 1st name | Rika |
| Middle name | |
| Last name | Motooka |
Organization
SOUKEN Co., Ltd.
Division name
secretariat
Zip code
105-0013
Address
DaiwaA Hamamatsucho Bldg. 3F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1555
Homepage URL
r_motooka@mail.souken-r.com
Sponsor or person
Institute
NIPPN CORPORATION
Institute
Department
Personal name
Funding Source
Organization
NIPPN CORPORATION
Organization
Division
Category of Funding Organization
Self funding
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,105-0013, JAPAN
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 | 11 | Month | 26 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 19 | 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 | 11 | Month | 22 | Day |
Last modified on
| 2024 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064262
