UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055842 |
|---|---|
| Receipt number | R000063789 |
| Scientific Title | Effects of test food on cognitive function |
| Date of disclosure of the study information | 2024/10/15 |
| Last modified on | 2025/11/11 14:49:58 |
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Basic information
Public title
Effects of test food on cognitive function
Acronym
Effects of test food on cognitive function
Scientific Title
Effects of test food on cognitive function
Scientific Title:Acronym
Effects of test food on cognitive function
Region
| Japan |
Condition
Condition
Healthy participants
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of 12 weeks of continuous intake of test food on cognitive function in a randomized, double-blind, placebo-controlled, parallel-group study. At the same time, the safety of the test food will also be examined.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Japanese version of the MCI Screen
Key secondary outcomes
(Secondary outcomes)
The Japanese version of the Pittsburgh Sleep Quality Index, POMS 2-A, BDNF
(Safety evaluation)
Vital signs, physical measurements (weight, BMI), blood biochemistry, hematology, urinalysis, adverse events
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
Continuous intake of test foods for 12 weeks
Interventions/Control_2
Continuous intake of control foods 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
| 50 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Japanese men and women aged between 50 and 75 years old at the time of obtaining written consent.
2.Participant who is aware of their cognitive decline.
3.Participant who has a MMSE-J score of 24 points or more.
4.Participant who has received sufficient explanation of the purpose and content of the research, and has the ability to consent.
Key exclusion criteria
1.Participant who has been diagnosed with dementia by a physician.
2.Participant who is taking medication or under medical treatment due to serious illness.
3.Participant who is under exercise therapy or dietetic therapy.
4.Participant who is at risk of showing allergic symptoms to 28 food allergens (7 allergens (egg, milk, wheat, peanut, shrimp, buckwheat, crab) required and 21 allergens (kiwifruit, walnut, soybean, banana, yam, cashew nut, peach, sesame, mackerel, salmon, squid, chicken, apple, macadamia nut, orange, beef, gelatin, pork, abalone, salmon roe, almond) recommended for labeling).
5.Participant who has or had a history of either drug or alcohol dependence syndrome.
6.Participant who currently attends a hospital for or has a history of mental disorder (depression, etc.) or sleep disorder (insomnia, sleep apnea syndrome, etc.).
7.Participant whose working hours are irregular due to night shifts, etc.
8.Participant who has extremely irregular lifestyle habits such as eating and sleeping.
9.Participant who has an extremely unbalanced diet.
10.Participant who smokes more than 21 cigarettes/day.
11.Participant who drinks alcohol heavily (average net alcohol intake of about 60 g/day or more).
12.Participant with a serious current or previous illness such as brain disease, malignant tumor, immunological disease, diabetes, liver disease (hepatitis), renal disease, cardiac disease, thyroid disease, adrenal disease, or other metabolic disease.
13.Participant who takes supplements, health foods, etc. (including food for specified health uses and food with functional claims) or medicines that affect cognitive functions for 4 days or more per week.
14. Participant who has a habit of taking products containing the functional substance of the test food.
Target sample size
136
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Miyazawa |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0023
Address
NAKANO SPRING Bld 5F, 4-11-17 Shibaura, Minato-ku, Tokyo 108-0023 Japan
TEL
03-3431-1260
rd@huma-rd.co.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Miyazawa |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0023
Address
NAKANO SPRING Bld 5F, 4-11-17 Shibaura, Minato-ku, Tokyo 108-0023 Japan
TEL
03-3431-1260
Homepage URL
rd@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
Tokyo Shinjuku Clinic Ethical Review Board
Address
5F,SIL Shinjuku-building ,2-46-3,Kabukicho,Shinjuku-ku,Tokyo,160-0021,Japan
Tel
03-6709-6071
tokyoshinjuku@taifukukai.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 | 10 | Month | 15 | 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
136
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 | 09 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 13 | Day |
Date of closure to data entry
| 2025 | Year | 07 | Month | 22 | Day |
Date trial data considered complete
| 2025 | Year | 08 | Month | 08 | Day |
Date analysis concluded
| 2025 | Year | 10 | Month | 29 | Day |
Other
Other related information
(Exclusion criteria continued)
15.Participant who has participated in other clinical studies within the past 3 months from the day of the consent acquisition, or who is planning to participate in other clinical studies during the current study.
16.Participant who has participated in blood collection or donation of more than 200 mL within the past 1 month, or more than 400 mL within the past 3 months, from the day of the consent acquisition.
17.Participant who is planning to get pregnant after the day of informed consent or is currently pregnant or lactating.
18.Participant who has difficulty abiding to responding various survey forms.
19.Participant who is judged as an inappropriate candidate according to the screening data.
20.Participant who is considered as an inappropriate candidate by the doctor in charge.
21.Participant who is unable to cooperate in infection control measures and various inspections.
Management information
Registered date
| 2024 | Year | 10 | Month | 15 | Day |
Last modified on
| 2025 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063789
