UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020552
Receipt number R000023729
Scientific Title The effect of plant-derived B on cognitive functions, a randomaized controlled trial.
Date of disclosure of the study information 2016/01/13
Last modified on 2016/07/13 10:23:21

* 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

The effect of plant-derived B on cognitive functions, a randomaized controlled trial.

Acronym

The effect of plant-derived B on cognitive functions.

Scientific Title

The effect of plant-derived B on cognitive functions, a randomaized controlled trial.

Scientific Title:Acronym

The effect of plant-derived B on cognitive functions.

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Effects of improvement on cognitive functions

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cognitive functions on pre and post of the study

Key secondary outcomes

SF-36 and analysis of blood


Base

Study type

Interventional


Study design

Basic design

Parallel

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 B, two packages per day, 16weeks

Interventions/Control_2

Intake of beverage without plant-derived A, two packages per day, 16weeks

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

69 years-old >=

Gender

Male and Female

Key inclusion criteria

1) have subjective memory impairment.
2) have showed 29 or more and 52 or less in the score of RBANS
3) have showed 24 or more and 27 or less in the score of Mini Mental State Examination

Key exclusion criteria

1) Subjects who have food allergy
2) Subjects who had stroke and cerebrovascular disease
3) heavy drinker and smoker
4) Subject who have hepatitis
5) Severe anemia
6) Medications treatment
7) Subjects who have taken cognitive battery
8) Subjects who participate in other clinical study
9) Subjects who take a psychotropic medicine
10) Subjects who take a health food
11) Inadequate with physician's decision
12) Green tea intake >= 3 cup/week

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Koikeda

Organization

Shiba Palace Clinic

Division name

Chair

Zip code


Address

6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan

TEL

03-5408-1590

Email

jimukyoku@mail.souken-r.com


Public contact

Name of contact person

1st name
Middle name
Last name Ko MASUDA

Organization

SOUKEN Co., Ltd

Division name

Management Division

Zip code


Address

3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan

TEL

03-5408-1555

Homepage URL


Email

k_masuda@mail.souken-r.com


Sponsor or person

Institute

Shiba Palace Clinic

Institute

Department

Personal name



Funding Source

Organization

Kao corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2016 Year 01 Month 13 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

2015 Year 11 Month 26 Day

Date of IRB


Anticipated trial start date

2016 Year 02 Month 08 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 01 Month 13 Day

Last modified on

2016 Year 07 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023729


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name