UMIN-CTR Clinical Trial

Public title

Effects of consumption of the test food on the cognitive function in healthy Japanese subjects

Acronym

Effects of consumption of the test food on the cognitive function in healthy Japanese subjects

Scientific Title

Effects of consumption of the test food on the cognitive function in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study

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 efficacy and safety of test food consumption for 12 weeks on the cognitive function in healthy Japanese subjects aged 40 or more

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. Efficacy Outcome
1-1. The measured value of the standardized score of composite memory at 12 weeks after consumption (12w)

Key secondary outcomes

1. Efficacy Outcomes
1-1. The amount of change of the standardized score of composite memory between screening (before consumption; Scr) and 12w

1-2. The measured value of 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} at four weeks after consumption (4w) and 12w

1-3. The amount of change of the standardized score of each cognitive domain from Scr to 4w and 12w

1-4. The measured values of each of the items of an original qustionaires at 4w and 12w

2. Safety Outcomes
2-1. Incidence of side effects

2-2. Incidence of adverse events

2-3. The proportion of subjects whose values of blood test and urinalysis are outside the reference range after intervention despite within the reference range at Scr

2-4. Physical measurement

2-5. Urinalysis

2-6. Blood test

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: 12 weeks
Test food: Drink containing beta-hydroxybutyric acid (BHB) (BHB 16.0 g/day)
Administration: Drink four bottles after breakfast and four bottles before going to bed

* 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

Duration: 12 weeks
Test food: Drink containing BHB (BHB 12.0 g/day)
Administration: Drink each four bottles after breakfast and four bottles before going to bed

* 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_3

Duration: 12 weeks
Test food: Drink not containing BHB
Administration: Drink four bottles after breakfast and four bottles before going to bed

* 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_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 who are judged as eligible to participate in the study by the physician

7. Subjects who have 24 points or more of MMSE (Mini Mental State Examination)

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 composite memory by Cognitrax

Key exclusion criteria

1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction

2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Subjects who currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases

4. Subjects who have dementia

5. Subjects who have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues

6. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use

7. Subjects who take supplements or foods that may be related to improving cognitive functions, such as docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), ginkgo leaf extract, tocotrienol, astaxanthin, gamma-aminobutyric acid (GABA), phosphatidylserine, and plasmalogen in daily use

8. Subjects who take blue-backed fish such as sardines, mackerel, and saury at least four times a week

9. Subjects who use devices, equipment, and applications that may affect cognitive functions (e.g., brain training puzzles, brain training games) in daily

10. Subjects currently taking medicines (include herbal medicines) and supplements

11. Subjects who are allergic to medicines and/or the test food related products

12. Subjects who are pregnant, breast-feeding, and planning to become pregnant

13. Subjects who suffer from COVID-19

14. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial

15. Subjects who are judged as ineligible to participate in the study by the physician

Target sample size

30

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

OSAKA GAS 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

2021

Year

10

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

33

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

Terminated

Date of protocol fixation

2021

Year

10

Month

13

Day

Date of IRB

2021

Year

10

Month

13

Day

Anticipated trial start date

2021

Year

10

Month

22

Day

Last follow-up date

2022

Year

03

Month

27

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2021

Year

10

Month

19

Day

Last modified on

2022

Year

07

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052283