UMIN-ICDS Clinical Trial

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

Healthy Japanese subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

NAGASE BeautyCare Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

Date of disclosure of the study information

2022

Year

06

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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/icdr_e/ctr_view.cgi?recptno=R000054843