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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024433
Receipt No. R000028121
Scientific Title A Clinical Study for Evaluating the Safety of Excessive Consumption of Beverages Containing Plant Extract. (Ex.no.H28-0827)
Date of disclosure of the study information 2016/10/18
Last modified on 2019/09/13

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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.H28-0827)
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.H28-0827)
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 Active
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 containing plant extract (commercial product)
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
Middle name
Last name Hiroshi Moriyama
Organization Kanazawabunko Hospital
Division name Deputy Director
Zip code
Address 2-6-22,Kamariyahigashi,Kanazawa-ku, Yokohama sity,Kanagawa,Japan
TEL 045-785-3311
Email nagashima@kanabun-hp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hitomi Nasu
Organization QOL RD Co.,Ltd.
Division name CRO Department Food Division
Zip code
Address 2-14-1,Nihonbashi,Chuo-Ku,Tkyo,
TEL 03-6386-8809
Homepage URL
Email h-nasu@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
Address
Tel
Email

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 金沢文庫病院(神奈川県)、白岡中央総合病院(埼玉県)、埼玉回生病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 18 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
2016 Year 09 Month 21 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 17 Day
Last modified on
2019 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028121

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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