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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000048134
Receipt No. 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 2022/06/23

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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
Email 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
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

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
Email 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
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 Open public recruiting
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
2022 Year 06 Month 23 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054843

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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