UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044305
Receipt number R000050608
Scientific Title Effects of consumption of the test food on the cognitive function in healthy subjects 40 years old or more: a randomized, double-blind placebo-controlled trial
Date of disclosure of the study information 2021/05/24
Last modified on 2022/02/25 13:40:06

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Basic information

Public title

Effects of consumption of the test food on the cognitive function in healthy subjects 40 years old or more

Acronym

Effects of consumption of the test food on the cognitive function in healthy subjects 40 years old or more

Scientific Title

Effects of consumption of the test food on the cognitive function in healthy subjects 40 years old or more: a randomized, double-blind placebo-controlled trial

Scientific Title:Acronym

Effects of consumption of the test food on the cognitive function in healthy subjects 40 years old 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 the cognitive function in healthy subjects 40 years old or more

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The measured values of the standardized score of composite 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) and 12w

2. The measured values of the standardized scores of 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, and brain derived neurotrophic factor (BDNF) at 12w

3.The amount of change of the standardized scores of 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, and BDNF between Scr and 12w

4. The measured values of all of the items of an original qustionaires at 4, 8, and 12w


Base

Study type

Interventional


Study design

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 need to know


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: 12 weeks
Test food: Food containing sugarcane stem extract
Administration: Take five capsules (100 mg sugarcane stem extract/capsule) with water after breakfast

* 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: Food containing low sugarcane stem extract
Administration: Take five capsules (50 mg sugarcane stem extract/capsule) with water after breakfast

* 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: Food not containing sugarcane stem extract
Administration: Take five capsules (without sugarcane stem extract) with water after breakfast

* 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



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 years old 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 are judged as eligible to participate in the study by the physician according to the results of Beck depression inventory (BDI)-II

8. Subjects who have a "yes" in the validity indicator of Cognitrax on both verbal memory and visual memory

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

10. Subjects who have a relatively low standardized score in composite memory by Cognitrax

Key exclusion criteria

1. Subjects who have at least one previous medical history of malignant tumor, heart failure or myocardial infarction

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

3. Subjects who are 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 are smokers

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

8. Subjects who take supplements 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

9. Subjects who take blue-backed fish such as sardines, mackerel, and saury more than four days per week

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

11. Subjects who currently taking medicines (include herbal medicines) and supplements

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

13. Subjects who are pregnant, breast-feeding, or planning to become pregnant after the agreement to participate in this trial

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

90


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

Mitsui Sugar 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

2021 Year 05 Month 24 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

99

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 05 Month 12 Day

Date of IRB

2021 Year 05 Month 12 Day

Anticipated trial start date

2021 Year 05 Month 24 Day

Last follow-up date

2021 Year 11 Month 07 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 05 Month 24 Day

Last modified on

2022 Year 02 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050608


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name