UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042950
Receipt No. 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

* 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 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
Institute IMEQRD Co., Ltd
Institute
Department

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
URL(English) https://upload.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


Contact us.