UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041271
Receipt number R000047134
Scientific Title A study to evaluate the effects of irradiation by test product on amount of ATP in the body Part2
Date of disclosure of the study information 2020/08/01
Last modified on 2020/12/10 16:15:22

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Basic information

Public title

A study to evaluate the effects of irradiation by test product on amount of ATP in the body Part2

Acronym

A study to evaluate the effects of irradiation by test product on amount of ATP in the body Part2

Scientific Title

A study to evaluate the effects of irradiation by test product on amount of ATP in the body Part2

Scientific Title:Acronym

A study to evaluate the effects of irradiation by test product on amount of ATP in the body Part2

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To confirm the effects of 60 minutes irradiation to be examined on blood ATP (Adenosine TriPhosphate) level in healthy male and female from 20 to 65 years old.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Adenosine Triphosphate

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

60 minutes irradiation to the top of head and lower abdomen.

Interventions/Control_2


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

65 years-old >

Gender

Male and Female

Key inclusion criteria

1. 20 to 64 years old
2. Healthy Japanese males and females.
3. Those who take breakfast, lunch and dinner everyday.
4. Those who can provide their written informed consent.

Key exclusion criteria

1.Those who are currently receiving drug treatment of chronic illness.
2.Those who have a current or a past medical history of severe diseases.
3.Those who have a past and current medical history of drug or food allergy.
4.Those who started taking any of the following products in the past three months: drugs, quasi-drug products, and also those who have been routinely taking these products. Those who intend to take these products during the study period.
5.Heavy drinkers.
6.Smoker
7.Those who work night shifts.
8.Those who are currently undergoing treatment for drug dependence or drug abuse or those who have a past medical history of either of them.
9.Those who are currently pregnant or breastfeeding or those who want to become pregnant during the study period.
10.Those who are currently participating in another clinical trial or those who took a test product and completed another clinical trial in a month.
11.Those who were determined by the principal investigator and the sub investigator to be unsuitable for participation in this clinical trial.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Masumi
Middle name
Last name Mizuno

Organization

Art of Creation Japan Co.,Ltd.

Division name

none

Zip code

171-0021

Address

3-3-10, Nishi-ikebukuro, Toshimaku,Tokyo, Japan

TEL

090-6510-7867

Email

Mas.mizuno7932@gmail.com


Public contact

Name of contact person

1st name Yoshitada
Middle name
Last name Hira

Organization

imeQ RD inc.

Division name

Sales department

Zip code

104-0061

Address

6-2-1 Ginza Chuo-ku Tokyo Japan

TEL

03-6704-5968

Homepage URL


Email

y-hira@imeqrd.co.jp


Sponsor or person

Institute

imeQ RD inc.

Institute

Department

Personal name



Funding Source

Organization

IPC Works Ltd.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Suda Clinic institutional review board

Address

2-8-14,Takadanobaba,Shinjyuku,Tokyo

Tel

03-6704-5968

Email

suda-clinic_irb@imeq.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

2020 Year 08 Month 01 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

2020 Year 07 Month 17 Day

Date of IRB

2020 Year 03 Month 31 Day

Anticipated trial start date

2020 Year 08 Month 01 Day

Last follow-up date

2020 Year 08 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 07 Month 31 Day

Last modified on

2020 Year 12 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047134


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name