UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048134 |
|---|---|
| Receipt number | R000054843 |
| Scientific Title | Effects of consumption of the test food on the cognitive function in healthy Japanese subjects: an open-label trial |
| Date of disclosure of the study information | 2022/06/22 |
| Last modified on | 2023/07/05 18:19:17 |
* 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
Effects of consumption of the test food on the cognitive function in healthy Japanese subjects: an open-label trial
Acronym
Effects of consumption of the test food on the cognitive function in healthy Japanese subjects: an open-label trial
Scientific Title
Effects of consumption of the test food on the cognitive function in healthy Japanese subjects: an open-label trial
Scientific Title:Acronym
Effects of consumption of the test food on the cognitive function in healthy Japanese subjects
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 the cognitive function as well as the secondary effects on vascular endothelial function and vascular age in healthy Japanese subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The standardized score of composite memory
Key secondary outcomes
1. The standardized scores of each cognitive domain {neurocognition index (NCI), verbal memory, visual memory, psychomotor speed, reaction time, complex attention, cognitive flexibility, processing speed, executive function, social acuity, reasoning, working memory, sustained attention, simple attention and motor speed}
2. Flow mediated dilation (FMD), maximum expansion width of the blood vessel*, and the resting vessel diameter
3. Vascular age, deviation value of vascular aging, waveform index, and low frequency / high frequency ratio
4. An original questionnaire (1."Are you told that you say the same thing repeatedly by people around you?", 2."Do you often forget where you put your things such as your wallet and keys and have to look for them?", 3."Do you sometimes find it difficult to say the words that you were going to say?", 4."Do you feel decline in attention and/or concentration?", 5."Do you sometimes find it difficult to show interest in new things due to lack of motivation?", 6."Do you sometimes forget other things to do while you are doing one thing?", 7. "Can you recall recent news or events and tell it somebody", 8."Do you sometimes lose the plot of a story during a conversation?", 9."Do you feel that you become more angry and/or suspicious easily?", 10."Do you feel that you make more mistakes in daily life such as cooking, cleaning up, calculating, or driving?", 11."Do you feel that you take more time to remember new things / you cannot remember new things / you forget it immediately?", and 12."Do you often feel that you cannot recall people's names?"
*Maximum expansion width of the blood vessel = the maximum dilated vessel diameter - the resting vessel diameter
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test food: Food containing fermented Ganoderma lucidum and rosemary extract
Administration: Take two packets with water without chewing at any time during the day
* Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2
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
| 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 whose scoring of Mini Mental State Examinination (MMSE) is 24 or more at Scr
7. Subjects who have a "yes" in the validity indicator of Cognitrax on both verbal memory and visual memory
8. Subjects whose the standardized score of composite memory measured by Cognitrax are relatively low
Key exclusion criteria
Subjects (who)
1.are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2.have a pacemaker or an implantable cardioverter defibrillator
3.currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4.use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily
5.currently taking medications (including herbal medicines) and supplements
6.are allergic to medicines and/or the test food related products
7.are pregnant, lactation, or planning to become pregnant
8.suffer from COVID-19
9.have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate in another trial during this trial
10.are judged as ineligible to participate in the study by the physician
11.have irregular working hours
12.have irregular ifestyles (such as diet, exercise, and sleep)
13.live with requiring long-term care persons
14.drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)}
15.take food/beverage containing functional ingredients which may influence cognitive function or vessel function
16.have dementia
17.have mental health issues such as depression disorder, attention deficit/hyperactivity disorder, or other issues
18.are smokers
19.currently undergoing treatment for hemorrhagic disease, hypotension, thrombocytopenia, convulsive disorder, bradycardia, pulmonary disease, gastrointestinal tract obstruction, peptic ulcer, hyperthyroidism, or urogenital obstruction
20.plan to have surgery within two weeks after this trial
Target sample size
16
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
NAGASE BeautyCare Co., Ltd.
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
| 2022 | Year | 06 | Month | 22 | 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
18
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 | 15 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 22 | Day |
Last modified on
| 2023 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054843
