UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037725
Receipt number R000043003
Scientific Title Effect of Probiotic Intake on Improvement of Higher Cerebral Function in Participants with Suspected Mild Cognitive Impairment
Date of disclosure of the study information 2019/08/23
Last modified on 2020/03/27 09:10:34

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Basic information

Public title

Effect of Probiotic Intake on Improvement of Higher Cerebral Function in Participants with Suspected Mild Cognitive Impairment

Acronym

Effect of Probiotic Intake on Improvement of Higher Cerebral Function in Participants with Suspected Mild Cognitive Impairment

Scientific Title

Effect of Probiotic Intake on Improvement of Higher Cerebral Function in Participants with Suspected Mild Cognitive Impairment

Scientific Title:Acronym

Effect of Probiotic Intake on Improvement of Higher Cerebral Function in Participants with Suspected Mild Cognitive Impairment

Region

Japan


Condition

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is to examine effect to give improvement of the higher brain function in healthy Japanese men and women aged less than 50 years or older 80 years old with suspected mild cognitive impairment who have continued to consume the test food for 16 weeks.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

RBANS

Key secondary outcomes

MCI screen


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


Institution consideration

Institution is not considered as adjustment factor.

Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

16-week intake of the test food

Interventions/Control_2

16-week intake of the placebo food

Interventions/Control_3


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

50 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

1)Japanese male and female aged less than 50 years or older 80 years old at the time of the informed.
2)Male and female with Japanese nationality.
3)Subject with an MMSE score of 22 or more.
4)Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.

Key exclusion criteria

1)Subject who is diagnosed as dementia.
2)Subject who is under exercise therapy or dietetic therapy.
3)Subject who has an allergy for test food.
4)Subject who has or had a history of either medicine or alcohol dependence syndrome.
5)Subject who has or had a history of mental illness (depression) or sleep disturbance.
6)Subject who is on a night-shift or is a shift worker.
7)Subject whose lifestyle is extremely irregular.
8)Subject who has an unbalanced diet.
9)ubjects who have disease or history of diabetes, liver disease(hepatitis), kidney disease, heart disease, thyroid disease, adrenal disease, and metabolic disease.
10)Subject who uses health foods, supplements, and medicines that may affect cognitive function
11)Subjects who has undergone surgery of the gastrointestinal tract(Appendicitis is excluded).
12)Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study.
13)Subject who has blood drawn 200mL within the past 1 months or 400mL within the past 3 months from the day of the consent acquisition.
14Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
15)Subject who can't keep the daily records.
16)Subject who is judged as an inappropriate candidate according to the screening data.
17)Subject who is considered as an inappropriate candidate by the doctor in charge.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Daisuke
Middle name
Last name Ochitani

Organization

HUMA R&D CORP

Division name

Clinical Development Division

Zip code

108-0014

Address

Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan

TEL

03-3431-1260

Email

ochitani@huma-rd.co.jp


Public contact

Name of contact person

1st name Daisuke
Middle name
Last name Ochitani

Organization

HUMA R&D CORP

Division name

Clinical Development Division

Zip code

108-0014

Address

Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan

TEL

03-3431-1260

Homepage URL


Email

ochitani@huma-rd.co.jp


Sponsor or person

Institute

HUMA R&D CORP

Institute

Department

Personal name



Funding Source

Organization

Morinaga Milk Industy Co, Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committees of Nihonbashi Egawa Clinic

Address

2F Kotobuki Build. 1-1-3 Yaesu Chuo-ku, Tokyo 103-0028 Japan

Tel

03-5204-0311

Email

jim@medipharma.co.jp


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



Other administrative information

Date of disclosure of the study information

2019 Year 08 Month 23 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

80

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

2019 Year 05 Month 20 Day

Date of IRB

2019 Year 06 Month 17 Day

Anticipated trial start date

2019 Year 08 Month 09 Day

Last follow-up date

2019 Year 12 Month 24 Day

Date of closure to data entry

2019 Year 12 Month 24 Day

Date trial data considered complete

2020 Year 01 Month 22 Day

Date analysis concluded

2020 Year 03 Month 26 Day


Other

Other related information



Management information

Registered date

2019 Year 08 Month 19 Day

Last modified on

2020 Year 03 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043003


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name