UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000018572
Receipt No. 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 (Ver. 9)

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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
Email 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
Email s-yoneda@qol-rd.co.jp

Sponsor
Institute QOL RD Co.,Ltd.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021498