UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053549 |
|---|---|
| Receipt number | R000061108 |
| Scientific Title | Examination of cerebral blood flow changes during food image presentation using fMRI |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2024/08/06 09:05:52 |
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Basic information
Public title
Examination of cerebral blood flow changes during food image presentation using fMRI
Acronym
Examination of cerebral blood flow changes during food image presentation using fMRI
Scientific Title
Examination of cerebral blood flow changes during food image presentation using fMRI
Scientific Title:Acronym
Examination of cerebral blood flow changes during food image presentation using fMRI
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the changes in cerebral blood flow in food image presentation after eating test food
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of cerebral blood flow
Key secondary outcomes
Questionnaire on palatability and feelings toward test foods
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
test food, Single intake
Interventions/Control_2
test food, Single intake
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
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Subjects who have experience of eating complex frozen desserts and like them
2)Subjects who have received fMRI
3)Right handed person
4)Healthy and free of chronic diseases
5)Subjects who have received explanation and understood about this study, and who can consent to the content on the informed consent documents.
6)Subjects who can come to the venue on the designated day and take measurements
Key exclusion criteria
1)Individuals using medical products.
2)Subjects whose medical history cannot be determined to have no effect on study participation
3)Subjects with alcoholism or a mental illness.
4)Subjects who used or applied a drug for treatment of disease in the past 1 month.
5)Subjects with food allergy.
6)Subjects who are a smoker.
7)Females who are or are possibly pregnant, or lactating.
8)Subjects who have had brain surgery or have brain disease
9)Claustrophobic
10)Subjects with tattoos
11)Subjects who have undergone correction or implants, and who have metal in their bodies such as metal plates or screws for prosthesis such as fractures.
12)Subjects who were hospitalized and received treatment in the past 6 months.
13)Subjects who participated in other clinical studies within three month of consent for participation in this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Kawamoto |
Organization
Morinaga & Co., Ltd.
Division name
R&D institute
Zip code
230-8504
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama
TEL
045-571-6140
m-kawamoto-hf@morinaga.co.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Yamamoto |
Organization
Morinaga & Co., Ltd.
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa
TEL
045-571-6140
Homepage URL
t-yamamoto-jc@morinaga.co.jp
Sponsor or person
Institute
Morinaga & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Morinaga & 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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Building 6F, 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
jimukyoku@mail.souken-r.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 | 07 | Month | 01 | 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
Completed
Date of protocol fixation
| 2023 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 16 | 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 | 02 | Month | 06 | Day |
Last modified on
| 2024 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061108
