UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038621
Receipt number R000043989
Scientific Title Exploratory study of test foods acting on autonomic nerves for men aged 20 to under 50
Date of disclosure of the study information 2019/11/19
Last modified on 2020/03/11 13:50:19

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Basic information

Public title

Exploratory study of test foods acting on autonomic nerves for men aged 20 to under 50

Acronym

Exploratory study of test foods acting on autonomic nerves for men aged 20 to under 50

Scientific Title

Exploratory study of test foods acting on autonomic nerves for men aged 20 to under 50

Scientific Title:Acronym

Exploratory study of test foods acting on autonomic nerves for men aged 20 to under 50

Region

Japan


Condition

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose is to search for test foods that act on autonomic nerves for Japanese males aged 20 to under 50.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Electronic pupillometer measurement data

Key secondary outcomes

Heart rate sensor measurement data,questionnaire


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is 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

Single intake of test food after conducting Uchida-Kraepelin test on the test day

Interventions/Control_2

Single intake of test food after conducting Uchida-Kraepelin test on the test day

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

20 years-old <=

Age-upper limit

50 years-old >

Gender

Male

Key inclusion criteria

1.Japanese male aged 20 years or older and younger than 50 years at the time of the informed consent.
2.Subjects without smoking habits
3.Subjects who can take alcohol
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 with BMI>=25kg/m2
2.Subject who have an onset or history of eye disease(Excludes mild illnesses such as infectious diseases)
3.Person with eyelid droop
4.Subject who have moved or changed their jobs within the last 3 months, separated from their close relatives, etc., and are likely to have great
5.Subject who is taking medication or under medical treatment because of some serious illness.
6.Subject who is under exercise therapy or dietetic therapy.
7.Subject who has an allergy for test food.
8.Subject who has or had a history of either medicine or alcohol dependence syndrome.
9.Subject who has or had a history of mental illness (depression) or sleep disturbance.
10.Subject who is on a night-shift or is a shift worker.
11.Subject whose lifestyle is extremely irregular.
12.Subject who has an unbalanced diet.
13.Subject who is disease or history such severe diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), kidney disease, heart disease, thyroid disease, adrenal disease, other metabolic diseases person.
14.Subject who uses health foods ,supplements, and medicines that are thought to affect autonomic nerves, sleep, and stress
15.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.
16.Subject who can't keep the daily records.
17.Subject who is considered as an inappropriate candidate by the doctor in charge.

Target sample size

20


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

Asahi Quality & Innovations 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 11 Month 19 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

23

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 11 Month 08 Day

Date of IRB

2019 Year 11 Month 11 Day

Anticipated trial start date

2019 Year 11 Month 19 Day

Last follow-up date

2019 Year 12 Month 18 Day

Date of closure to data entry

2019 Year 12 Month 19 Day

Date trial data considered complete

2019 Year 12 Month 24 Day

Date analysis concluded

2020 Year 01 Month 31 Day


Other

Other related information



Management information

Registered date

2019 Year 11 Month 19 Day

Last modified on

2020 Year 03 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043989


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name