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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028223
Receipt No. R000032304
Scientific Title Safety evaluation for excessive intake of drink containing plant derived extractive.
Date of disclosure of the study information 2017/07/13
Last modified on 2017/11/17

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Basic information
Public title Safety evaluation for excessive intake of drink containing plant derived extractive.
Acronym Safety evaluation for excessive intake of drink containing plant derived extractive.
Scientific Title Safety evaluation for excessive intake of drink containing plant derived extractive.
Scientific Title:Acronym Safety evaluation for excessive intake of drink containing plant derived extractive.
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the safety of excessive intake of drink containing plant derived extractive for 4 weeks.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hematologic test, Blood biochemistry test, Urine test, Blood pressure/pulsation, Weight/body mass index, Interview, before and 2, 4 weeks after intake and Adverse events thorough the study.
Key secondary outcomes

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 Intake of drink containing plant derived extractive, 3-fold quantity of recommended daily intake, for 4 consecutive 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
64 years-old >=
Gender Male and Female
Key inclusion criteria Healthy males and females aged 20-64 years old.
Key exclusion criteria 1. Subjects who constantly use supplements in addition to the normal meal richly containing polyphenol.
2. Subjects having a current or past history of serious diseases such as diabetes, hepatic or renal disorder, or cardiovascular disease.
3. Subjects having possibilities for emerging allergy related to the study.
4. Subjects having a disease requiring treatment or a history of serious diseases for which medication was required.
5. Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination.
6. Subjects who have participated in other clinical studies within the last one month prior to the current study or are planned to participate in other studies after obtaining informed consent for the current study.
7. Subjects who intend to become pregnant or lactating.
8. Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire.
9. Subjects who are judged as unsuitable for this study by physician.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sadao Mori
Organization Morinaga & Co.,Ltd.
Division name Health and Wellness Headquarters
Zip code
Address 2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama.
TEL 045-571-2982
Email s-mori-ab@morinaga.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriko Watanabe
Organization TTC Co.,Ltd.
Division name Clinical Research Planning Department
Zip code
Address Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo.
TEL 03-5459-5329
Homepage URL
Email n.watanabe@ttc-tokyo.co.jp

Sponsor
Institute TTC Co.,Ltd.
Institute
Department

Funding Source
Organization Morinaga & 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
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

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 13 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
2017 Year 06 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 14 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
2017 Year 07 Month 13 Day
Last modified on
2017 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032304

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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