UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038180 |
|---|---|
| Receipt number | R000043526 |
| Scientific Title | A study to evaluate the safety of excessive intake of test food in a healthy adult subject |
| Date of disclosure of the study information | 2019/10/02 |
| Last modified on | 2020/10/09 12:01:07 |
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Basic information
Public title
A study to evaluate the safety of excessive intake of test food in a healthy adult subject
Acronym
A study to evaluate the safety of excessive intake of test food in a healthy adult subject
Scientific Title
A study to evaluate the safety of excessive intake of test food in a healthy adult subject
Scientific Title:Acronym
A study to evaluate the safety of excessive intake of test food in a healthy adult subject
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examine the safety of 4-weeks excessive ingestion of a food containing plant extracts in a healthy adult subject
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of adverse events and side effects
Key secondary outcomes
(1) Physical measurement (Body weight, Body mass index, body fat percentage)
(2) Physical examination
(3) Blood biochemical test
(4) Hematological test
(5) Urinalysis
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 | Device,equipment |
Interventions/Control_1
Oral intake of the test product with a plant extract (10 tablets per day; 4 weeks)
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)Healthy adult males and females from 20 to 64 years of age.
(2)Subjects who participate in this study with a written informed consent.
Key exclusion criteria
(1) Subjects who receive a drug treatment
(2) Subjects who have a history of serious disorder (heart disease, liver disease, kidney, digestive system disease, or et al.)
(3) Females who have diagnosed pregnancy or is breast-feeding
(4) Subjects who have medication or food allergy
(5) Subjects who have excessive alcohol-drinking
(6) Subjects who have extremely irregular dietary habits
(7) Subjects who are participating in other trial, have participated in the past 4 weeks, or plan to participate in other trial during scheduled period in this trial
(8) Subjects who have made a blood donation of 200 mL within the last one month prior to this study
(9) Male subjects who have made a blood donation of 400 mL within the last three months prior to this study (10) Female subjects who have made a blood donation of 400 mL within the last four months prior to this study
(11) Male subjects who have made a blood donation over an amount (1,200 mL minus the estimated volume of blood sampling during the study) within the last one year prior to this study
(12) Female subjects who have made a blood donation over an amount (800 mL minus the estimated volume of blood sampling during the study) within the last one year prior to this study
(13) Subjects judged as unsuitable for the study by the investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Yamamoto |
Organization
House Wellness Foods Corporation
Division name
Research and Development Institute
Zip code
664-0011
Address
Imoji 3-20, Itami, Hyogo, Japan
TEL
072-778-1127
Yamamoto_Yoshihiro@house-wf.co.jp
Public contact
Name of contact person
| 1st name | Ryusei |
| Middle name | |
| Last name | Uchio |
Organization
House Wellness Foods Corporation
Division name
Research and Development Institute
Zip code
664-0011
Address
Imoji 3-20, Itami, Hyogo, Japan
TEL
072-778-1127
Homepage URL
Uchio_Ryusei@house-wf.co.jp
Sponsor or person
Institute
Research & Development Institute, House Wellness Foods Corporation
Institute
Department
Personal name
Funding Source
Organization
House Wellness Foods Corporation
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwauchikannda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.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 | 10 | Month | 02 | 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
| 2019 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 02 | Day |
Last modified on
| 2020 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043526
