UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048084 |
|---|---|
| Receipt number | R000054792 |
| Scientific Title | Effects of test foods on cognitive function |
| Date of disclosure of the study information | 2022/06/17 |
| Last modified on | 2023/06/19 11:23:53 |
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Basic information
Public title
Effects of test foods on cognitive function
Acronym
Effects of test foods on cognitive function
Scientific Title
Effects of test foods on cognitive function
Scientific Title:Acronym
Effects of test foods on cognitive function
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of 12 weeks of continuous intake of test foods on cognitive function in a randomized, double-blind, placebo-controlled, parallel-group study. At the same time, we will confirm the safety of the test food.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
BDNF,Cognitrax
Key secondary outcomes
(Secondary outcomes)
Brain Health Check (expanded version), Pittsburgh Sleep Questionnaire
(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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Continuous intake of test foods 1 for 12 weeks
Interventions/Control_2
Continuous intake of test foods 2 for 12 weeks
Interventions/Control_3
Continuous intake of control foods for 12 weeks
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 50and 75 years old at the time of obtaining written consent.
2. Subject who is aware of cognitive decline.
3. Subject who has a MMSE-J score of 22 points or more.
4.Subject who has received sufficient explanation of the purpose and content of the research, has the ability to consent.
Key exclusion criteria
1.Subject who has been diagnosed with dementia by a physician.
2.Subject who is taking medication or under medical treatment due to serious illness.
3.Subject who is under exercise therapy or dietetic therapy.
4.Subject who is at risk of showing allergic symptoms to 28 food allergens (7 allergens (egg, milk, wheat, peanut, shrimp, buckwheat, crab) obligated and 21 allergens (kiwifruit, walnut, soybean, banana, yam, cashew nut, peach, sesame, mackerel, salmon, squid, chicken, apple, matsutake mushroom, orange, beef, gelatin, pork, abalone, salmon roe, almond) recommended for labeling)
5.Subject who has or had a history of either medicine or alcohol dependence syndrome.
6.Subject who are currently attends a hospital or has a history of mental disorder (depression, etc.) or sleep disorder (insomnia, sleep apnea syndrome, etc.)
7.Subject whose working hours are irregular due to night shifts, etc.
8.Subject who has extremely irregular lifestyle habits such as eating and sleeping.
9.Subject who has an extremely unbalanced diet.
10.Smoking more than 21 cigarettes/day or heavy alcohol drinkers (average net alcohol intake of about 60 g/day or more)
11.Subject 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.
12.Subject 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.
13.Subjects who has a habit of taking products containing ingredients of test foods.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hidemasa |
| Middle name | |
| Last name | Toya |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0014
Address
Round Cross Tamachi 9F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
03-3431-1260
toya@huma-rd.co.jp
Public contact
Name of contact person
| 1st name | Hidemasa |
| Middle name | |
| Last name | Toya |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0014
Address
Round Cross Tamachi 9F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
03-3431-1260
Homepage URL
toya@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
Ethics Committees of Yoga Allergy Clinic
Address
4-32-16 Yoga,Setagaya-ku,Tokyo 158-0097 Japan
Tel
03-5491-4478
jim@medipharma.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
| 2022 | Year | 06 | 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
60
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
| 2022 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 08 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 28 | Day |
Date trial data considered complete
| 2023 | Year | 01 | Month | 25 | Day |
Date analysis concluded
| 2023 | Year | 04 | Month | 13 | Day |
Other
Other related information
(Exclusion criteria continued)
14.Subject 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.
15.Subject who has blood collection or donation more than 200mL within the past 1 month or more than 400mL within the past 3 months from the day of the consent acquisition.
16.Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
17.Subject who has difficulty observing records on various survey forms.
18.Subject who is judged as an inappropriate candidate according to the screening data.
19.Subject who is considered as an inappropriate candidate by the doctor in charge.
20.Subject who is unable to cooperate with the countermeasures against SARS-CoV-2 infection and PCR testing as stipulated by the government and local authorities according to the status of SARS-CoV-2 infection.
Management information
Registered date
| 2022 | Year | 06 | Month | 17 | Day |
Last modified on
| 2023 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054792
| Research Plan | |
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| Registered date | File name |
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