UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044919 |
|---|---|
| Receipt number | R000051309 |
| Scientific Title | A verification study for improving cognitive function with consumption of the test food in healthy subjects aged 40 or more: A randomized double-blind placebo-controlled trial |
| Date of disclosure of the study information | 2021/07/20 |
| Last modified on | 2022/03/23 13:01:20 |
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Basic information
Public title
A verification study for improving cognitive function with consumption of the test food in healthy subjects aged 40 or more
Acronym
A verification study for improving cognitive function with consumption of the test food in healthy subjects aged 40 or more
Scientific Title
A verification study for improving cognitive function with consumption of the test food in healthy subjects aged 40 or more: A randomized double-blind placebo-controlled trial
Scientific Title:Acronym
A verification study for improving cognitive function with consumption of the test food in healthy subjects aged 40 or more
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of the test food on cognitive function in healthy subjects aged 40 or more
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The measured value of the standardized score of visual memory at 12 weeks after consumption (12w)
Key secondary outcomes
1. The amount of change of the standardized score of composite memory between screening (before consumption; Scr) or start intake (0w) and 12w
2. The measured values and amounts of changes from Scr or 0w of the standardized score of other cognitive domains at 12w
3. The measured values and amounts of changes from 0w in each of the following items at 12w: physical component summary (PCS), mental component summary (MCS), role component summary (RCS), physical functioning, role physical, bodily pain, general health, activity, social functioning, role emotional, and mental health, brain derived neurotrophic factor (BDNF), Tumor Necrosis Factor-alpha (TNF-alpha), Interleukin-6 (IL-6), Biological Antioxidant Potential (BAP), d-Reactive Oxygen Metabolites (d-ROM)
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test food: Food 1 (Low dose)
Administration: Take two pieces per day
Interventions/Control_2
Duration: 12 weeks
Test food: Food 2 (High dose)
Administration: Take two pieces per day
Interventions/Control_3
Duration: 12 weeks
Test food: Control food
Administration: Take two pieces per day
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Subjects aged 40 or more
4. Healthy subjects
5. Subjects who are aware of the decline in their memory function
6. Subjects who are judged as eligible to participate in the study by the physician
7. Subjects whose scoring of Mini Mental State Examinination (MMSE)-J is 24 or more at Scr
8. Subjects who have a "yes" in the validity indicator of Cognitrax on both verbal memory and visual memory
9. Subjects who have a relatively low standardized score in visual memory by Cognitrax at Scr
Key exclusion criteria
Subjects (who)
1.have a history or current history of serious diseases of the heart, liver, kidneys, or digestive organs, or a history of major digestive system surgery such as gastrectomy, gastrointestinal suture, or intestinal resection
2.have a pacemaker or an implantable cardioverter defibrillator
3.are a treatment for chronic diseases
4.have significant abnormalities in blood pressure, physical and/or hematological data
5.have severe anemia
6.are pre- or post-menopausal women with severe physical changes
7.have dementia
8.have mental health issues
9.take medications and supplements
10.take supplements and/or foods related to improving cognitive functions, and/or take blue-backed fish at least 4 times a week
11.use devices, equipment, and applications that may affect cognitive functions at least 4 times a week
12.are allergies (particularly to wheat, eggs, milk, and soy)
13.are smoker
14.are heavy alcohol intake
15.with extremely irregular life rhythms
16.are on a carbohydrate restriction or diet, or who plan diet during the test period
17.have eaten less than one meal per day at least once a week for the past a month
18.may change their lifestyles during the test period
19.can't do the following actions: replace the main meal with test food at any 2 meals, receive the test food twice per week, and/or store test foods in frozen storage
20.are pregnant, breast-feeding, or planning to become pregnant
21.have been enrolled in other clinical trials within the last 4 weeks (wks) before the agreement to participate in this trial or plan to enroll in another clinical trial during trial period or within 4 wks after test period
22.donated blood before consuming the food (whole blood either 400 mL within 16 wks [women] or 12 wks [men], 200 mL within 4 wks [both], or blood components within 2 wks [both])
23.are judged as ineligible to participate in the study by the physician
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
Nisshin Seifun Group Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel
03-5793-3623
IRB@takara-clinic.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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 20 | 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
24
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
| 2021 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 20 | Day |
Last modified on
| 2022 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051309
