UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029163
Receipt number R000033345
Scientific Title Study of the effects of the food containing plant-derived ingredient on brain function and its associated symptoms -A randomized, double-blind, placebo-controlled, crossover study-
Date of disclosure of the study information 2017/09/15
Last modified on 2020/03/04 16:22:56

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Study of the effects of the food containing plant-derived ingredient on brain function and its associated symptoms -A randomized, double-blind, placebo-controlled, crossover study-

Acronym

Effects of plant-derived ingredient on brain function.

Scientific Title

Study of the effects of the food containing plant-derived ingredient on brain function and its associated symptoms -A randomized, double-blind, placebo-controlled, crossover study-

Scientific Title:Acronym

Effects of plant-derived ingredient on brain function.

Region

Japan


Condition

Condition

Mild cognitive impairment (MCI) and mild dementia.

Classification by specialty

Neurology Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To confirm the effects of the plant-derived ingredient on brain function and its associated symptoms in MCI and dementia.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Neuropsychological tests before and after the 12-week treatment period (MMSE, ADAS-cog, Trail Making Test and CDR)

Key secondary outcomes

Epworth sleepiness scale, blood analyses, questionnaires


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Intake of beverage containing plant-derived ingredient (active beverage), twice a day, for 12 weeks. -Washout for 4 weeks. -Intake of beverage without plant-derived ingredient (placebo beverage), twice a day, for 12 weeks.

Interventions/Control_2

Intake of placebo beverage, twice a day, for 12 weeks. -Washout for 4 weeks. -Intake of active beverage, twice a day, for 12 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



Eligibility

Age-lower limit

60 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

1) MCI or mild dementia patients who are between 60 and 85 years old at the time of registration.
2) Subjects who shows 23 or more scores in MMSE.
3) Subjects who haven't taken treatment for cancer, myocardial infarction, or stroke within the past 5 years.
4) Subjects who do not take drugs used to treat dementia (Aricept, Reminyl, Rivastach, Memary)
5) Subjects who are not depressed with the GDS scores of less than 5.
6) Subjects who can visit the clinic on appointed days.
7) Subjects who can fully understand the purpose and contents of this study, and voluntarily agree to participate in this study with written consent.

Key exclusion criteria

1) Subjects who have food allergy.
2) Subjects who underwent surgery for cerebrovascular disease.
3) Subjects who take medicine that may influence the outcome of this study (e.g., antipsychotic drug).
4) Subjects who take supplement or food that may influence the outcome of this study (e.g., food for specified health uses).
5) Subjects who experienced unpleasant feeling during blood collection.
6) Subjects who have participated in other clinical study within the last 4 weeks.
7) Heavy drinker and smoker.
8) Subjects who have extremely irregular dietary pattern.
9) Subjects who don't agree to the purpose and contents of this study.
10) Subjects who drink more than two or more cups of coffee daily.
11) Subjects who are judged unsuitable for participating in this study by doctors.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Takashi
Middle name
Last name Asada

Organization

Memory Clinic Ochanomizu

Division name

Chief director

Zip code

113-0034

Address

1-5-34, Yushima, Bunkyo-ku, Tokyo, Japan

TEL

+81-3-6801-8718

Email

asada@memory-cl.jp


Public contact

Name of contact person

1st name Yoshika
Middle name
Last name Komori

Organization

KSO Corporation

Division name

Sales Department

Zip code

105-0023

Address

1-9-7 Shibaura, Minato-ku, Tokyo, Japan

TEL

+81-3-3452-7733

Homepage URL


Email

yoshi@kso.co.jp


Sponsor or person

Institute

KSO Corporation

Institute

Department

Personal name



Funding Source

Organization

Kao Corporation

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

Shinagawa Season Terrace Health Care Clinic

Address

Minato-ku, Tokyo, Japan

Tel

03-3452-3381

Email

tomohiro_kogo@sempos.or.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

医療法人社団 創知会 メモリークリニックお茶の水


Other administrative information

Date of disclosure of the study information

2017 Year 09 Month 15 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


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

2017 Year 08 Month 28 Day

Date of IRB


Anticipated trial start date

2017 Year 09 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete

2018 Year 09 Month 03 Day

Date analysis concluded

2018 Year 09 Month 27 Day


Other

Other related information



Management information

Registered date

2017 Year 09 Month 15 Day

Last modified on

2020 Year 03 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033345


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name