UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042950
Receipt number R000049031
Scientific Title Study to evaluate the safety of overconsumption of test food
Date of disclosure of the study information 2021/01/17
Last modified on 2021/04/15 14:57:21

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Basic information

Public title

Study to evaluate the safety of overconsumption of test food

Acronym

Study to evaluate the safety of overconsumption of test food

Scientific Title

Study to evaluate the safety of overconsumption of test food

Scientific Title:Acronym

Study to evaluate the safety of overconsumption of test food

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety of test food by ingesting 5 times the defined amount for 4 weeks in healthy men and women aged between 20 and 64.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Incidence of side effects and adverse events

Key secondary outcomes

General hematology / blood biochemistry tests, urinalysis, physiotherapy, vital signs


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

Prevention

Type of intervention

Food

Interventions/Control_1

Take 10 tablets of test food with water after breakfast

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

64 years-old >

Gender

Male and Female

Key inclusion criteria

1. Aged between 20 and 64 years at the time of informed consent
2. Japanese male or female
3. Participant who can input electronic diary with smartphone/PC
4. Participant who can provide written consent

Key exclusion criteria

1. using medication or Chinese medication (except for the drugs as needed)
2. on diet / exercise therapy under the guidance of a doctor
3. history or current episode of serious diseases such as heart failure, myocardial infarction
4. history of gastrointestinal surgery (except for appendicitis)
5. taking healthy food or supplements daily
6. allergic for some drugs or food
7. participation in another clinical trial in the previous one month, currently, or during the trial.
8. pregnant or lactating, or willing to be pregnant during the trial
9. Alcohol consumption of >60g equivalent
10. heavy smoker (21 or more cigarettes /day)
11. on irregular diet, working in shift or late at night
12. donate component blood or 200ml of whole blood in the previous one month before the trial, or planning to donate blood during the trial
13. donate 400ml of whole blood in the previous three months before the trial
14. judged by the investigator to be unsuitable for participating in this study

Target sample size

12


Research contact person

Name of lead principal investigator

1st name Naoki
Middle name
Last name Igari

Organization

Daiwa Pharmaceutical Co., Ltd.

Division name

Research and Development Department

Zip code

154-0024

Address

1-16-19 Sangenjaya Setagaya-ku Tokyo

TEL

03-5430-4050

Email

igari@daiwa-pharm.com


Public contact

Name of contact person

1st name Hirokuni
Middle name
Last name Kayama

Organization

IMEQRD Co., Ltd

Division name

Sales department

Zip code

104-0061

Address

6-2-1 Ginza Chuo-ku Tokyo

TEL

03-6704-5968

Homepage URL


Email

h-kayama@imeqrd.co.jp


Sponsor or person

Institute

IMEQRD Co., Ltd

Institute

Department

Personal name



Funding Source

Organization

Daiwa Pharmaceutical 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

Suda Clinic institutional review board

Address

2-8-14,Takadanobaba,Shinjyuku,Tokyo

Tel

03-6704-5968

Email

n-yuzawa@imeqrd.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

2021 Year 01 Month 17 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 12 Month 04 Day

Date of IRB

2020 Year 12 Month 22 Day

Anticipated trial start date

2021 Year 01 Month 18 Day

Last follow-up date

2021 Year 03 Month 17 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 01 Month 08 Day

Last modified on

2021 Year 04 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049031


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name