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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name