UMIN-CTR Clinical Trial

Public title

A study to evaluate the impact of test food ingestion on cerebral blood flow

Acronym

A study to evaluate the impact of test food ingestion on cerebral blood flow

Scientific Title

A study to evaluate the impact of test food ingestion on cerebral blood flow

Scientific Title:Acronym

A study to evaluate the impact of test food ingestion on cerebral blood flow

Region

Japan

Condition

Healthy people

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effects of test food on cerebral blood flow

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Cerebral blood flow

Key secondary outcomes

Correlation between each result including cerebral blood flow

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

Blocking

Concealment

No need to know

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of the test food (6 weeks).

Interventions/Control_2

Intake of control food (6 weeks).

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

45

years-old

<=

Age-upper limit

60

years-old

>=

Gender

Male and Female

Key inclusion criteria

1)Adult of both sexes aged from 45 to 60 years old at time of informed consent provided
2)Subjects confirmed to be healthy on pre-observation inspection
3)Subjects who are right handed
4)Subjects whose native language is Japanese
5)Subjects who are competent to consent and give voluntary consent in writing with full understanding after receiving explanation of this study aim and contents

Key exclusion criteria

1.Subjects with current medical history and history of serious disorders that influence this study
2.Subjects with surgical history of head or foreign metal in their head
3.Subjects who are under hormone treatment, or who have been diagnosed as climacterium
4.Subjects with history of heart disease or heart pacemakers
5.Subjects with pollen allergy
6.Subjects with difficulty of color discrimination
7.Subjects whose visual or hearing acuity is too low to perform tests, or who have been diagnosed as amblyopia, blindness, or deafness
8.Subjects who may have physical deconditioning due to test foods
9.Subjects who have diseases requiring regular administration, or who have anamnesis of severe diseases
10.Subjects who are under treatment for brain function, or who regularly intake drugs or health foods that influence brain function more than once a week
11.Subjects who regularly intake drugs or health foods that influence cerebral blood flow more than once a week
12.Subjects who regularly intake foods resembling test food or energy drink more than once a week
13.Subjects who are, or are planning to be pregnant or nursing during study
14.Subjects who sometimes have irregular lifestyles during study
15.Subjects who regularly drink alcohol beyond proper quantity
16.Smokers, or subjects who initiated smoking cessation within 12 months
17.Subjects who undergo brain function tests within 12 months
18.Subjects who make 200 mL or 400 mL blood donation within 3 months
19.Subjects who are participating in other clinical trials within 1 month or who are planning to participate in other clinical trials during study
20.Subjects who are suspected of dementia
21.Subjects considered to be unsuitable for enrollment based on lifestyle questionnaire or cerebral blood flow measurement
22.Subjects who work in a company developing functional foods
23.Subjects who are judged as unsuitable by doctor

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Kuniaki Obara

Organization

Kirin Company, Limited

Division name

Research and Development Division, Research Laboratories for Health Science and Food Technologies

Zip code

Address

1-13-5, Fukuura Kanazawa-ku, Yokohama, Kanagawa, Japan

TEL

080-1930-9932

Email

k-obara@kirin.co.jp

Name of contact person

1st name
Middle name
Last name	Shigeru Imai

Organization

KT Medical Corporation

Division name

Food clinical trial Division

Zip code

Address

6F 2-2-3 Marunouchi,Chiyoda-ku, Tokyo, Japan

TEL

03-5223-8811

Homepage URL

Email

imai@kt-medical.co.jp

Institute

KT Medical Corporation

Institute

Department

Personal name

Organization

Kirin Company, Limited

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

ブレストヘルスクリニック（東京都）

Date of disclosure of the study information

2020

Year

09

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2018

Year

11

Month

29

Day

Date of IRB

Anticipated trial start date

2019

Year

02

Month

04

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2019

Year

01

Month

11

Day

Last modified on

2019

Year

01

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040471