UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018572 |
|---|---|
| Receipt number | R000021498 |
| Scientific Title | A Clinical Study for Evaluating the Safety of Excessive Consumption of Beverages Containing Plant Extract. (Ex.no.H27-0608) |
| Date of disclosure of the study information | 2016/03/31 |
| Last modified on | 2020/03/31 23:11:42 |
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Basic information
Public title
A Clinical Study for Evaluating the Safety of Excessive Consumption of Beverages Containing Plant Extract. (Ex.no.H27-0608)
Acronym
A Clinical Study for Evaluating the Safety of Excessive Consumption of Beverages Containing Plant Extract.
Scientific Title
A Clinical Study for Evaluating the Safety of Excessive Consumption of Beverages Containing Plant Extract. (Ex.no.H27-0608)
Scientific Title:Acronym
A Clinical Study for Evaluating the Safety of Excessive Consumption of Beverages Containing Plant Extract.
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of excessive consumption of beverage containing plant extract for 4 weeks in healthy adult.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Medical examination by blood biochemistry, hematology, urinalysis, physical examination at 2-week and 4-week consumption.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
test food containing plant extract
4 weeks excessive consumption.
Interventions/Control_2
control food without plant extract
4 weeks excessive consumption.
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) subjects aged 20 to 64 years old.
(2) Subjects giving written informed consent.
Key exclusion criteria
(1) Subjects with serious medical history of hepatic, renal, cardiovascular, respiratory and intestinal disease.
(2) Subjects taking any kind of medicine or supplement which affect the result of the trial for habitual use.
(3) Subjects with serious food allergy .
(4) Subjects who are judged as unsuitable for the study by the investigator for the other reasons.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shinichiro |
| Middle name | |
| Last name | Take |
Organization
Saitama Kaisei Hospital
Division name
Director
Zip code
340-0825
Address
455.Daibara.Yashio-city.Saitama
TEL
048-995-3331
kaisei-ijika@cure.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Soichi |
| Middle name | |
| Last name | Yoneda |
Organization
QOL RD Co.,Ltd.
Division name
CRO Department Food Division
Zip code
103-0023
Address
2-14-1,Nihonbashi,Chuo-Ku,Tkyo,
TEL
03-6386-8809
Homepage URL
s-yoneda@qol-rd.co.jp
Sponsor or person
Institute
QOL RD Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kao 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
Saitama Kaisei Hospital IRB
Address
455,Ohara, Yashio
Tel
048-995-3331
kaisei-ijika@cure.ocn.ne.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
埼玉回生病院（埼玉県）、白岡中央総合病院（埼玉県）、横浜なみきリハビリテーション病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Unpublished due to the protocol including the intellectual property rights
Publication of results
Unpublished
Result
URL related to results and publications
works in progress
Number of participants that the trial has enrolled
32
Results
No significant difference in the primary outcome
Results date posted
| 2020 | Year | 03 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy subjects
Participant flow
32 participants completed and 32 subjects were incorporated into the analyses
Adverse events
No adverse effect related to the test diets reported
Outcome measures
Safety
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 06 | Day |
Last modified on
| 2020 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021498
