UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056072 |
|---|---|
| Receipt number | R000064053 |
| Scientific Title | Confirmation of the effects of food intake on cognitive function in healthy subjects |
| Date of disclosure of the study information | 2024/11/17 |
| Last modified on | 2025/03/19 13:40:01 |
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Basic information
Public title
Confirmation of the effects of food intake on cognitive function in healthy subjects
Acronym
Confirmation of the effects of food intake on cognitive function in healthy subjects
Scientific Title
Confirmation of the effects of food intake on cognitive function in healthy subjects
Scientific Title:Acronym
Confirmation of the effects of food intake on cognitive function in healthy subjects
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of food intake on cognitive function in healthy subjects using placebo as a control
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cognitive function tests (Cognitrax long)
Key secondary outcomes
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
One packet (30.0 g as solids) of the test food is dissolved in the prescribed amount of water (120 mL) and taken at once
Interventions/Control_2
One packet (30.0 g of solids) of placebo is dissolved in the prescribed amount of water (120 mL) and taken at once
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females from 20 to 64 years of age
(2) Those whose first language is Japanese
(3) BMI at the time of pre-examination is 18.5 kg/m 2 or more and less than 30 kg/m 2
(4) Those who do not have abnormalities in fasting blood glucose at the time of pre-examination and changes in blood glucose after maltodextrin loading
(5) Those who fully understand the purpose and content of the research and agree to participate in the research of their own free will
Key exclusion criteria
(1) Those who have a habit of drinking alcohol on a daily basis (40 g or more of alcohol equivalent/day), and those who have lifestyle habits that interfere with evaluation, such as irregular sleep schedule.
(2) Those who are judged to be unsuitable as subjects based on the results of the pre-examination
(3) Those who are prescribed or regularly use medications that may affect cognitive function
(4) Those who consume health foods such as specified health foods and functional foods related to cognitive function at least one day per week
(5) Those who have had abnormalities in clinical laboratory values or cardiopulmonary function, and are judged to have a problem participating in the study
(6) Those who may develop allergies in relation to the study, those who are at risk of developing seasonal allergies such as hay fever during the research period
(7) Those who have a disease that requires constant medication, those who have a disease under treatment, who have symptoms of memory impairment such as dementia or sleep disorders, or who are undergoing treatment those who have a history of serious disease that required medication
(8) Those whose physical measurements, physical examination values, and clinical examination values before the start of intake were significantly out of the reference range
(9) Those who work in shifts, work late at night, and have an irregular daily rhythm
(10) Those who are participating in the other study within one month prior to the start of this study
(11) Those who plan to become pregnant or breastfeed during the study period
(12) Those who have a smoking habit
(13) Those who are not good at blood sampling tests or those who have difficulty collecting blood
(14) Those who are judged to be unsuitable as subjects based on the answers to the background survey
(15) Those who are judged as unsuitable for the study by the investigator for other reason
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Nakagawa |
Organization
NIHON SHOKUHIN KAKO CO., LTD.
Division name
RESEARCH INSTITUTE
Zip code
417-8530
Address
30 Tajima Fuji, Shizuoka
TEL
0545-53-5995
yoshinori.nakagawa@nisshoku.co.jp
Public contact
Name of contact person
| 1st name | Rio |
| Middle name | |
| Last name | Fujiwara |
Organization
EP Mediate Co., Ltd.
Division name
Development Department Trial Planning Section
Zip code
162-0821
Address
Kagurazaka AK Bldg., 1-8 Tsukudocho, Shinjuku-ku, Tokyo
TEL
070-7079-8488
Homepage URL
fujiwara.rio605@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
NIHON SHOKUHIN KAKO CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@eps.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
医療法人財団 同仁記念会 明和病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 17 | 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
| 2024 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 24 | 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 | 06 | Day |
Last modified on
| 2025 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064053
