UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052067 |
|---|---|
| Receipt number | R000059427 |
| Scientific Title | Study to confirm the effects of test food ingestion on brain activity |
| Date of disclosure of the study information | 2024/04/26 |
| Last modified on | 2023/08/31 11:27:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study to confirm the effects of test food ingestion on brain activity
Acronym
Study to confirm the effects of test food ingestion on brain activity
Scientific Title
Study to confirm the effects of test food ingestion on brain activity
Scientific Title:Acronym
Study to confirm the effects of test food ingestion on brain activity
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify effects of test foods on brain activity.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of brain activity (objective and subjective evaluations)
Key secondary outcomes
Safety Assessment (adverse events and side effects)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single ingestion of test food > washout period > single ingestion of placebo food.
Interventions/Control_2
Single ingestion of placebo food > washout period > single ingestion of test food.
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females aged over 18 to under 30 when informed consent.
(2) Subjects who first language is Japanese.
(3) Subjects who have received enough explanation and understood about this study, and who can obtain informed consent documents.
(4) Subjects who are able to come to the measurement facility on the designated measurement date and take the measurement.
Key exclusion criteria
Subjects who
1)fasting blood glucose of 126 mg/dL or higher
2)have chronic physical illness
3)have or are being treated for memory impairment disease symptoms such as dementia
4)have alcoholism or other mental disorders
5)currently have some kind of disease and are receiving drug treatment
6)have received any kind of drug treatment(except for a history of abortive medication such as headache, menstrual cramps, common cold, etc.)for one month prior to obtaining consent
7) have currently, or within the past 3 months, continuously using drugs that claim to maintain or enhance cognitive function
8)have currently, or within the past 3 months have been, or will be during the study period, continuously consuming functional foods, health foods, or supplements that claim to maintain or enhance cognitive function
9)have undergone medical treatment involving hospitalization within the past 6 months, or those who are scheduled to be hospitalized during the examination period
10)have current medical history or past medical history of serious disease in heart, liver, kidney, digestive organ
11)who have been diagnosed with iron deficiency anemia by a physician or determined to have iron deficiency anemia by medical examination or other means
12)may develop seasonal allergic symptoms such as hay fever during the study period
13) have food allergies (including a history of food allergies) (especially milk and gelatin)
14)Pregnant, lactating, or possibly pregnant, or planning to become pregnant during the study period
15)Subjects with smoking habit
16)may change their lifestyle during the study period (drastic change in club activities, long trips, etc.)
19)currently participating in another clinical trial, or one month has not passed since participation in another clinical trial
22)were judged ineligible for enrollment in the study by the principal investigator or sub-investigator
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Toshihiro |
| Middle name | |
| Last name | Kawama |
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, JAPAN
TEL
0455716140
t-kawama-jb@morinaga.co.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Matsui |
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, JAPAN
TEL
0455716140
Homepage URL
y-matsui-jd@morinaga.co.jp
Sponsor or person
Institute
R&D Institute
Morinaga & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
R&D Institute
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
Chiyoda paramedical care clinic Institutional Review Board
Address
3-3-10 Honngokucyo Nihonbashi Cyuo-ku Tokyo
Tel
0362259005
IRB@cpcc.co.jp
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 | 04 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 28 | 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 | 08 | Month | 31 | Day |
Last modified on
| 2023 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059427
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
