UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033570
Receipt number R000038268
Scientific Title Effect on concentration (and cognitive function) by single ingestion of a test food
Date of disclosure of the study information 2018/08/20
Last modified on 2019/01/17 16:26:23

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Basic information

Public title

Effect on concentration (and cognitive function) by single ingestion of a test food

Acronym

Effect on concentration (and cognitive function) by single ingestion of a test food

Scientific Title

Effect on concentration (and cognitive function) by single ingestion of a test food

Scientific Title:Acronym

Effect on concentration (and cognitive function) by single ingestion of a test food

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 was to investigate the effect of a single dose of the test food on concentration in healthy Japanese men and women aged 30 years or older and younger than 50 years.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cognitrax,Uchida Kraepelin test

Key secondary outcomes

POMS2 shorter version,VAS questionnaire,Salivary marker


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

Prevention

Type of intervention

Food

Interventions/Control_1

On the day intake of the test food
Wash out
On the day intake of the placebo

Interventions/Control_2

On the day intake of the placebo
Wash out
On the day intake of the test 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

30 years-old <=

Age-upper limit

50 years-old >

Gender

Male and Female

Key inclusion criteria

1)Japanese men and women aged 30 to younger than 50 at the time of informed consent
2)Non smoker
3)A person who has received sufficient explanation of the purpose and content of the research, is capable of giving informed consent, voluntarily volunteers to participate in the research, and consents to participate in the research in writing.

Key exclusion criteria

1)Patients currently receiving any type of drug or outpatient treatment
2)Subjects who are currently receiving exercise or dietary therapy under the supervision of a physician.
3)Persons with a history or current or concurrent liver disease or serious renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic disease.
4)Patients with a history of drug or food allergy
5)Those who wish to do so during pregnancy, lactation, or the duration of the study.
6)Persons with serious or past brain diseases.
7)Subjects who have received blood donations or vaccinations within the previous 3 months or have scheduled them during the study period.
8)People who routinely consume health foods, supplements, and medicines that may affect concentration
9)Persons with a history of psychiatric disorders (e.g., depression), sleep disorders, or psychiatric disorders in the past.
10)Alcoholism, substance abuse, or substance abuse with treatment or a history of treatment.
11)Employees working during night shifts, etc.
12)Excessively irregular lifestyle such as eating or sleeping
13)Subjects who have participated in other clinical studies or have participated in other clinical studies within the previous 3 months.
14)Persons who are difficult to comply with the records of various surveys
15)Other than the above, the principal investigator judged that the subject was ineligible for the study.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ochitani Daisuke

Organization

HUMA R&D CORP

Division name

Clinical Development Division

Zip code


Address

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

TEL

81-3-3431-1260

Email

ochitani@huma-rd.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

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

TEL

81-3-3431-1260

Homepage URL


Email

ochitani@huma-rd.co.jp


Sponsor or person

Institute

HUMA R&D CORP

Institute

Department

Personal name



Funding Source

Organization

Asahi Group Holdings,Ltd

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

2018 Year 08 Month 20 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

2018 Year 07 Month 13 Day

Date of IRB


Anticipated trial start date

2018 Year 08 Month 20 Day

Last follow-up date

2018 Year 10 Month 20 Day

Date of closure to data entry

2018 Year 10 Month 29 Day

Date trial data considered complete

2018 Year 10 Month 29 Day

Date analysis concluded

2018 Year 12 Month 25 Day


Other

Other related information



Management information

Registered date

2018 Year 07 Month 31 Day

Last modified on

2019 Year 01 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038268


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name