UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030859
Receipt number R000035234
Scientific Title Examination on an effect of continuous intake of a test food product on improving cognitive function in young adults.
Date of disclosure of the study information 2018/01/18
Last modified on 2018/04/18 13:18:17

* 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

Examination on an effect of continuous intake of a test food product on improving cognitive function in young adults.

Acronym

Examination on an effect of continuous intake of a test food product on improving cognitive function in young adults.

Scientific Title

Examination on an effect of continuous intake of a test food product on improving cognitive function in young adults.

Scientific Title:Acronym

Examination on an effect of continuous intake of a test food product on improving cognitive function in young adults.

Region

Japan


Condition

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine an influence of a test food product on cognitive function in healthy Japanese males and females aged 25 and over, below 35 by assigning them to take the test food product for 2 weeks on a continuous basis.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cognitrax, Uchida-Kraepelin test, VAS

Key secondary outcomes

Hematologic test, blood biochemical test, vital signs


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

Central registration


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

2-week intake of the test food

Interventions/Control_2

2-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

25 years-old <=

Age-upper limit

35 years-old >

Gender

Male and Female

Key inclusion criteria

1)Age: 25 and over, below35
2)Sex: Males and females with Japanese nationality
3)Those who are able to take 9 capsules a day for 2 weeks
4)Non-smoker
5)Workers (excluding students)

Key exclusion criteria

1)Currently in treatment with medication or seeing a doctor for treatment
2)Previous history of hepatic disorder or severe disorder related to kidney, endocrine, cardiovascular system, gastro-intestine, lung, blood, or metabolism, or currently presence of complications
3)Previous history of drug allergy or food allergy
4)Regular intake of a food product or supplements with a possible influence on cognitive function
5)Regular intake of drug with a possible influence on cognitive function
6)Extreme faddiness
7)Extremely irregular lifestyle such as a dietary pattern and a sleeping pattern
8)Suspicion of insomnia
9)Presence or previous history of mental disorder (depression, etc.)
10)Presence or previous history of alcoholism
11)Current participation in another clinical trial or participation in another clinical trial within the last three months
12)Irregular work hours such as working on night shift
13)Determined by the investigator to be unsuitable for enrollment in this study

Target sample size

42


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takihara Takanobu

Organization

ITO EN, Ltd.

Division name

Central Research Institute

Zip code


Address

21 Mekami, Makinohara-shi, Shizuoka 421-0516, Japan

TEL

0548-54-1247

Email

t-takihara@itoen.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ochitani Daisuke

Organization

HUMA R&D CORP

Division name

Clinical Development Division

Zip code


Address

Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan

TEL

81-3-3431-1260

Homepage URL


Email

ochitani@huma-c.co.jp


Sponsor or person

Institute

HUMA R&D CORP

Institute

Department

Personal name



Funding Source

Organization

ITO EN,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


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

2018 Year 01 Month 18 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 12 Month 08 Day

Date of IRB


Anticipated trial start date

2018 Year 01 Month 28 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

2018 Year 01 Month 17 Day

Last modified on

2018 Year 04 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035234


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name